Intrathecal drug delivery is an effective pain management option for patients with chronic and cancer pain. The delivery of drugs into the intrathecal space provides superior analgesia with smaller doses of analgesics to minimize side effects while significantly improving quality of life. This article aims to provide a general overview of the use of intrathecal drug delivery to manage pain, dosing recommendations, potential risks and complications, and growing trends in the field. The spinal cord is a key anatomical site for pain processing and more specifically the dorsal horn of the spinal cord within the intrathecal space. There are various receptor targets within the spinal column that can be utilized in relieving pain. These receptors include opioid , GABA, alpha-2, dopaminergic, NMDA as well as sodium and calcium channels2. The advantage of delivering the medication directly into the CSF in smaller dosages to target the specific receptors is that it may reduce the systemic side effects and the direct delivery to the site of action allows a more rapid and effective response. As a popular alternative for patients experiencing cancer or chronic pain, intrathecal analgesia has become a therapeutic option for patients who have exhausted all other treatment avenues as well as patients experiencing side effects from their current treatment options. The system uses a small pump that is surgically placed under the skin of the abdomen and delivers medication through a tunneled catheter directly into the intrathecal space3. The pump is refilled periodically through a subcutaneous access port in an office setting utilizing a sterile technique. The pump can be programmed to be a fixed-rate, constant flow device or a variable rate pump with the option of boluses via patient controlled analgesia programming using a wireless radiofrequency transmitter given to the patient1. In contrast to more conservative oral or intravenous delivery methods, ITDD is becoming increasingly popular for its efficacy in managing cancer and chronic pain. This review will specifically target ITDD uses for patients with cancer-related pain although its use has also been very popular in patients with chronic non-cancer pain.Intrathecal drug delivery (ITDD or IDD) is a method which provides analgesia by a direct continuous infusion of medication into the cerebrospinal fluid (CSF). The rationale is based on the concept that direct delivery into the CSF within the intrathecal space avoids crossing the blood-brain barrier and allows delivery of smaller doses than oral, intravenous, transdermal or epidural drug administration4. Pain is often considered as the most feared symptom amongst individuals living with cancer and it can occur at any point during the course of the illness. Pain is often also the first sign of malignancy4. Pain is also often associated with the treatment of cancer and it can present itself as both acute and chronic pain. Furthermore, advancement of the disease process can lead to pain or make the existing pain worse. It is difficult to estimate the prevalence of cancer pain because of a lack of standardization in definitions of pain and in the measures used to assess it5. The other factor that makes it challenging in estimating the prevalence is the heterogeneity of nociceptive and neuropathic pain conditions6. About 50% of patients will report pain as a symptom at the time of cancer diagnosis and early in the course of disease6. Its prevalence increases to 75% or more at advanced stages. A strategy should be devised to evaluate the prevalence of pain in patients with cancer by separating the pain related to the disease process, to its treatment, or to unrelated causes.The incidence of deaths due to cancer has been estimated to be 6.6 million people globally each yearet al. published in the Annals of Oncology in 20074, the range of reported prevalence of pain is highest for the following tumors:Head and neck (67–91%)Prostate (56–94%)Uterine (30–90%)Genitourinary (58–90%)Breast (40–89%)Pancreatic (72–85%)According to a systematic review of the past 40 years by van den Beuken7. There is increasing evidence that intrathecal opioids are superior to oral delivery in malignant pain, especially when narcotic dosage is limited by its side effects1. It is believed that this advantage results from delivering extremely small doses on target receptors in the spinal column8.The various treatment options for cancer pain generally depend on the location, character, duration, its origin, and the success or failure of previous and ongoing treatments. Treatment options for cancer-related pain include oral non-steroidal anti-inflammatory drugs, oral opioid analgesics, neuropathic pain medications, parenteral opioids, peripheral nerve blocks, neurolysis such as celiac plexus blocks, local anesthetic injections, spinal cord stimulation, continuous epidural analgesia, and intrathecal pumps. In most cases, multiple forms of treatment are used for the most effective treatment combination. Opiates such as morphine, dilaudid, fentanyl, and sufentanil are most commonly administered via the intrathecal drug delivery system for cancer-related and non-malignant painThere are other agents also available to treat neuropathic pain, spasticity related pain, sympathetic pain, and visceral pain  2012 which lists the algorithms for intrathecal therapies in both neuropathic and nociceptive pain . The alg10 involving 120 patients with non-malignant pain syndromes found that the patients benefited from the intrathecal opiate therapy and the average pain reduction was 67.4% after 6 months from implantation. Over ninety percent of the patients were satisfied with the therapy and 81% reported an improvement in their quality of life.A retrospective study9.Besides opiates, other medications such as baclofen (GABA agonist) for spasticity related pain, ziconotide  for severe chronic neuropathic pain, bupivicaine , clonidine , and ketamine (NMDA antagonist) have also been used in various instances and in specific patient groups. In addition, ITDD systems can also be used to deliver chemotherapy agents such as floxuridine and methorexate for the treatment of primary or metastatic cancer3. Baclofen is a GABA-A receptor agonist which can have a prominent effect on the motor tone via direct hyperpolarization of the motor horn cells. It is most often utilized in patients suffering from spasticity, cerebral palsy, amyotrophic lateral sclerosis, Stiff-Pearson syndrome, and those suffering from brain and spinal cord injuries7.One of the most common uses of the ITDD system is the delivery of baclofen for spasticity related pain3. In intrathecal drug delivery or ITDD, medication is delivered directly into the CSF in the intrathecal space  or disease progression is difficult to assess from a single-shot trial or even with a brief 72–96 hour infusion. A trial may also lead to underestimation of the failure rate and potential side effects. Still, the rationale for performing trials is based on the intuitive basis that it best mimics the system that would eventually be implanted7. Generally speaking, there is currently no solid base to either refute or adopt preimplantation trials but it is generally recommended although not required2. The British Pain Society expert panel suggested that trials should always be performed before the implantation of an intrathecal drug delivery system7.There have been various publications and consensus guidelines in regards to a screening trial before proceeding with pump implantationThere is a spectrum of intrathecal system options that range from a percutaneous catheter/external pump to a totally implanted system. Choice is dependent on a number of factors including, but not limited to, life expectancy, cost and availability of professional expertise and patient’s wishes and comfort level.In general, percutaneous refers to a medical procedure in which a catheter or a medical device is introduced into the body via needle-puncture of the skin. This approach is favored because the catheter is easy to place (fluoroscopy can be used to confirm the position of the catheter and to maneuver it into the desired location) and is suitable for patients with limited life expectancy. The catheter is then attached to an external pump which delivers the medication directly into the intrathecal space. However, it is generally considered only a temporary option due to limitations such as frequent monitoring for infection, catheter migration, and patient’s immobility. The risks from this procedure are similar to performing a spinal anesthetic which includes bleeding, infection, headache, spinal cord damage, etc.Fully implanted drug delivery systems are suitable for long-term use. Mobility and functional activity are not particularly adversely affected by these systems. The implantation is performed by a skilled health care provider in an operating room under monitored anesthesia care with local anesthetic infiltration or general anesthesia. The patients require specialized care with a full multi professional infrastructure including regular follow-up appointments for pump refills. The pump can be programmed to be a fixed-rate, constant flow device or a variable rate pump with the option of boluses via patient controlled analgesia programming using a wireless radiofrequency transmitter given to the patient. Fixed rate delivery systems are less expensive than variable rate delivery systems but lack flexibility of medication delivery based on the need of a patient. These systems have a larger reservoir volume which allows for longer intervals between refills. In cases of suspected or actual medication overdose or implant malfunction, the pump’s drug reservoir has to be emptied and the device is interrogated by a designated health care professional.There are two systems available for implantable intrathecal devices–those that are programmable and those that are fixed-rate. In addition, some systems come with a bolus option that gives patients more control in managing their treatment. The needs of the patient as well as the suitability of the system for use with selected drugs need to be considered when deciding between the options.Programmable devices such as Medtronic’s SynchroMed system deliver a specific amount of medication intermittently . These sConstant flow systems such as Codman’s 3000 delivers a continuous amount of medication into the intrathecal space. These devices are favorable because they are generally less expensive, do not require a battery to operate and possess a larger drug reservoir that allows the drug to be delivered for a longer period of time before requiring a refill. However, constant rate devices are disadvantageous because they don’t give the flexibility to change the programming or a patient controlled bolus option for additional analgesia.11. It is a remote hand-held device which communicates with the implanted pump and allows the patient to self administer boluses based on the medication limits which are pre-programmed by the clinical provider. This system gives patients the ability to activate a bolus option when adequate pain relief is not achieved. The clinical care provider has the ability to set the number of boluses a patient may receive in a 24 hour period. There is a lockout system in place with the programmer that does not allow the patient to self activate the bolus option more than what it is allowed based on the settings created by the clinical provider. This allows for flexibility for the patients who have more intimate needs to control their pain based on certain body positions, movement, time of the day, and/or progression of their underlying disease. There are several safety options built in to the device such as the maximum number of boluses the patient may self administer in a 24 hour period, maximum dosage of the total drug in a 24 hour period, lockout in-between bolus activation, and the duration of time during which a bolus is administered.The Medtronic SynchroMed II infusion system comes with a Patient Therapy Manager (PTM) which is a trademark of the Medtronic CorporationThe placement of ITDD consists of two parts: 1) placement of the catheter in the intrathecal space surrounding the spinal cord and 2) placement of the pump/reservoir in the abdomen/flank region. The pump is implanted in the lower abdomen and is attached to the intrathecal catheter which is tunneled under the skin from the patient’s back towards the abdomen. The procedure requires two surgical incisions: 1) Lower back where the catheter is inserted into the intrathecal space and is secured to the fascia. 2) The lower abdominal wall to create a pocket for the pump. The procedure generally takes 3 to 4 hours from start to finish.13. This is because ITDD has less adverse effects than other pain treatments, so patients can endure more aggressive levels of chemotherapy or radiation.Patient selection is an important consideration. Patients who are good candidates for ITDD therapy include those that have significant side effects from oral or IV opioids which hinders titration of these agents to adequate analgesia. Another criterion includes patients who do not achieve adequate analgesia in spite of significant doses of oral opioids. These pumps are implanted by pain physicians and neurosurgeons. When implanted by pain physicians, they continue to manage the pump as well. Neurosurgeons primarily implant the pump which they then send back to pain specialists or palliative specialists to manage. It has been shown that ITDD for pain management can actually help patients on cancer therapies such as chemotherapy or radiationPrior to the procedure, a thorough evaluation is performed by the anesthesiologist to ensure patient’s ability to undergo surgery and anesthesia. Physical exam, blood tests, electrocardiogram, and chest x-rays may be requested by the provider. Current systemic use of analgesics is discontinued as well as anticoagulants and antiplatelet therapies. The position of the pump is proposed and agreed upon by the patient and provider keeping patients’ comfort, activity, need for future procedures and rehabilitation matters in consideration. The choice of medication is dependent on the success of past and present medication choices and acceptable side effects. This is usually pre-determined from either previous efficacy of a particular medication or during a trial period.12. Real time fluoroscopy is used to identify the ideal location for placement of the catheter via a needle provided by the device manufacturer. A small skin incision is made in the middle of the back to expose the fascia over the bony arch (lamina) of the vertebra and the catheter is placed in the subarachnoid, or intrathecal space and then anchored into the fascia to prevent migration.Implantation of an ITDD system is a minor surgical procedure that is carried out in the operating room using aseptic precautions, including skin preparation, sterile draping, and the use of full surgical attire. The patient is positioned in a lateral decubitus position with the patient’s side for the pump pocket nondependentOnce the catheter is in place and secure, a tunneling device is used to pass the catheter under the skin from the spine to the abdomen where the pump will be implanted. A 4–6 inch skin incision is made in the side of the abdomen below the waistline. The surgeon then creates a pocket for the pump between the skin and muscle layers and the catheter is attached to the pump. Once the connector is attached to the pump, the pump is correctly positioned under the skin and secured to the thick fascia layer overlying the stomach muscles using suture loops. A space inside the pump called the reservoir is filled with the desired medication and the pump is programmed. The incisions in the back and abdomen are closed with sutures or staples and a dressing is applied. The patient is taken to the recovery area and is monitored per the standard requirements of the institution before being discharged.Often antibiotics are prescribed to prevent complications and a one week follow-up is recommended. There may be temporary restriction on daily activities to allow for healing of the wound and pump to settle. Once healed, no special care is necessary.th–300th of the amount of medication is used with the pump delivery as compared with the amount when taken orally. A survey conducted among a small group of physicians highly-experienced in ITDD revealed that morphine was the more frequently used and prescribed choice of medication, both alone and in combination with other drugs14. The concentrations and daily dosages administered of medications varied from patient to patient. Providers often adjusted the dosages of drugs or drug combinations by a fixed percentage, between 10% and 20%, whether increasing or decreasing the dosage. An average of five to eight adjustments in dosage was completed before a different drug or drug combination was introduced in cases of inadequate analgesia13.As mentioned previously, ITDD delivers medicine directly into the cerebrospinal fluid, bypassing the route that oral medication takes through the body. Generally 1/1007. Long-term intrathecal application of opioid medications in cases of cancer pain is substantially more effective than its systemic application. Intrathecally applied opioids exert a strong analgesic effect via spinal receptors, without significantly influencing motor, sensory, and sympathetic reflexes. It has been shown to improve patients’ overall mood and reduces the incidence of systemic side effects. As a result, patients have reported an improvement in quality of life and the ability to participate more fully in daily activities. Furthermore, a randomized controlled study illuminates the efficacy of ITDD over comprehensive medical management in treating refractory cancer pain13. Patients receiving ITDD not only had better pain control and relief, but also had improved survival, a reduction in drug toxicity, and fewer drug side effects13.Studies have suggested that ITDD is effective in providing pain relief to 60–80% of patients experiencing chronic malignant painAs with any surgical procedure, serious complications may arise post-implant that require immediate attention and perhaps the removal of the device.15 showed that the most common complication was patients’ adverse reaction to a drug. Pharmacological complications were the most common immediately post-implant and generally subsided as treatment continued. Serious complications include respiratory depression/arrest, anaphylaxis, and meningitis with introduction of contaminated solution. It was also found that certain opioids (the drugs of choice) were more prone to complications than others. For example, the incidence of tip catheter granulomas is higher with morphine and hydromorphone as compared to fentanyl which has been upgraded to a first-line drug in the algorithm due to that specific advantage7.A retrospective study15 found catheter related complications as the most common cause of repeat surgery. Despite suturing the catheter to the underlying fascia, coiling of the tube and leakage at the connection site remains a problem. A study reviewing complications from long-term intrathecal drug therapy found that the annual rate for complications requiring surgical procedure was 10.5%, with 35% being pump related and 65% catheter related2. Errors in pump programming have also been reported and resulted in incorrect flow rates. Device related complications have led to infections (meningitis), pockets abscesses, bleeding, pain and discomfort, and blood or fluid in the pump’s pocket.Catheter and pump related malfunctions are one of the main sources of complications. In fact, one study16, with all infections appearing within the first three months post-implant. Factors that increased the potential risk of complication included psychological problems, obstructive sleep apnea, immunosuppression, smoking, diabetes active infections, bleeding disorders, and concurrent anticoagulation therapy7. A data analysis found that one successful measure to further decrease the chance of infection was adherence to guidelines and recommendations for surgical site infections17.Although rare, patient induced complications generally involve infections at implant location. Immune cells form a mass, known as a granuloma, around the catheter tip to wall off foreign substances. However, the incidence of infections in all cases reviewed during a study was 0.7% per year9. These standards apply to compounding of solutions by various routes, including intrathecal administration. There are strict provisions in place for considerations such as: training of personnel, a segregated sterile compounding area, air quality of the compounding area, certification and calibration of equipment, a cleaning and disinfection program, and a quality assurance program7. Any violation of any of the provisions can result in a civil and criminal law suit in addition to the suspension of the privileges to dispense compounded medications. An outbreak of fungal meningitis resulted in 2012 when several lots of contaminated methylprednisolone vials were used for epidural steroid injections in various states which were obtained from a compounding pharmacy. Shortly following the outbreak, the device manufacturer Medtronic released an "Urgent Medical Device Safety Notification" in November 2012 discouraging the use of unapproved drugs with its delivery system9.The FDA and the United States Pharmacopoeia have issued standards on compounded sterile products that have clinical, legal, and practical significance18.With estimates of pain care treatment costs exceeding $1 billion annually in the United States, cost and efficacy are important factors in clinical decision making. Although the initial cost of intrathecal drug delivery is substantially more, maintenance costs over time are significantly lower than conventional routes of administration. Cost analyses by the group concluded that intrathecal delivery is the most cost-effective route of opioid administration for patients who require long-term management of cancer (≥ 3–6 months) or nonmalignant pain (≥ 11–22 months)et al. showed that intrathecal therapy is a cost-effective method of treating chronic nonmalignant pain caused by failed back syndrome and that the break-even point occurs at 28 months, after which conventional pain therapy is the more expensive treatment option19. A separate analysis by Scott Guillemette from Ingenix Consulting on patients suffering from failed back surgery syndrome concluded with similar results. Despite the higher upfront costs, patients utilizing intrathecal drug delivery returned to ‘normal living’ more quickly than those with conventional therapy and the break-even point between the two points occurred between months 19 and 2020.An analysis by Kumar8. The spinal cord is a key anatomical site for pain processing and more specifically the dorsal horn of the spinal cord within the intrathecal space8. The advantage of delivering the medication directly into the CSF in smaller dosages is that it may reduce the systemic side effects and the direct delivery to the site of action allows a more rapid and effective response. As a popular alternative for patients experiencing cancer or chronic pain, intrathecal analgesia has become a therapeutic option for patients who have exhausted all other treatment avenues as well as patients experiencing side effects from their current treatment options. However, there are limitations such as adequate patient selection, ability to tolerate the procedure, and costs. There are also potential complications related to the device, drug, and procedure that may require hospitalization and immediate removal/revision of the device. Despite numerous studies involving existing and novel drugs, only limited data is available to address the issue of medication safety, efficacy, stability and compatibility with the intrathecal drug delivery system. As this option becomes more popular with patients and physicians, future research should focus on cross-site studies that would provide a more accurate outlook on this type of delivery.The treatment of pain poses an ongoing challenge to the healthcare field and better prevention, assessment and treatment of pain is needed. Intrathecal drug delivery can become a critical component of this transformation in treatment when more conservative forms of pain management have failed to provide adequate pain relief. In comparison to more conservative delivery methods such as drugs administered orally or intravenously, ITDD is more effective because the medication is directly introduced into the subarachnoid space I have read this submission. I believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. I have read this submission. I believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. This is an informative review  that provides the basic information and rationale for using ITDD for the treatment of cancer pain.  I have one major reservation and a few suggestions: 1. Cancer pain can be managed by a variety of practitioners; in the majority of situations it will fall under the purview of the patient’s primary oncologist or a primary care physician, who typically are unfamiliar with ITDDs. It would be very helpful, in my view, to add a paragraph that would outline in more detail when one should start thinking about referring a patient for consideration of ITDD? What criteria does the patient need to meet? E.g. life expectancy? Whom such patients should be referred to? Who will manage the pump after the implantation? How is it going to affect further treatment such as chemotherapy or radiation? What kind of treatment break one can expect? This kind of information is crucial for the treating oncologist. Some of this information is already in the text, however it would be very useful to organize it better and add some more specific and practical information. Perhaps in a form of a table?   A few clarifications may be needed:Table 2: - Is Meperidine still used as an opioid in ITDD? Its clinical use, especially in cancer pain, has been basically eliminated. - NMDA receptor – consider adding Methadone. Methadone is an opioid but also has NMDA activityPage 7: - In the US, the commonly used term is  “cancer pain”, instead of “carcinoma pain”Marcin Chwistek, MD FAAHPMI have read this submission. I believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. I don't see that the question of the difference in thickness between the 20cc and 40cc pumps was addressed.I have read this submission. I believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. This article gives a broad overview of the various types of ITDD systems used in the management of complex cancer pain. It also discusses the advantages, the common side-effects and complications, the technique and cost-effectiveness of using ITDD systems. Overall the article is useful in providing an understanding for doctors and nurses not familiar with the intrathecal drug delivery systems.  The article is written at a basic level and although it is useful to beginners and people who are not well versed in ITDD, it does not deliver much to experienced practitioners. I have reservations as I feel that this review article would have been of a higher standard if it was more comprehensive.I have read this submission. I believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Thank you very much for your response. This article was written for general practitioners to gain an understanding of ITDD systems for cancer pain. Page 3: There can be a need for increasing doses of opioids as tolerance develops.Page 5: There is a difference in thickness of the 20cc and 40cc pumps.Page 6: The lamina is not routinely exposed unless laminotomy leads are being placed.et al. (2002) J Clin Oncol.Smith TJ for efficacy.Page 7: Referenceet al. (2004) Follett KAnesthesiology for complications.Page 7: ReferencePage 7: (Table 5) – Ziconotide is not an opioid.I have read this submission. I believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Thank you very much for your response. Page 3: There can be a need for increasing doses of opioids as tolerance develops. We understand and agree with your comment; however, we are unsure as to where you feel this statement should to be added within the article. Page 5: There is a difference in thickness of the 20cc and 40cc pumps. We understand and agree with your comment; however, we are unsure as to where you feel this statement fits in the article.Page 6: The lamina is not routinely exposed unless laminotomy leads are being placed.6.2 Operating room procedure - We have changed the sentence to say that the incision is made to expose the fascia over the bony arch (lamina).Page 7: Reference et al. (2002) J Clin Oncol.Smith TJ  for efficacy.  A discussion of this article has been added into the efficacy section to show that ITDD is a better system of pain management than comprehensive medical management for patients with cancer pain.  et al. (2004) Follett K Anesthesiology for complications.Page 7: Reference   After reviewing this article, it has been added into our article that in order to further decrease the chances of infection, there must be an adherence to guidelines and recommendations regarding surgical site infections. Page 7: (Table 5) – Ziconotide is not an opioid.              Ziconotide has been taken out of the chart.


The National Institute for Health and Clinical Excellence guidelines recommend acupuncture as a clinically effective treatment for chronic back pain. However, there is insufficient knowledge of what factors contribute to patients’ positive and negative experiences of acupuncture, and how those factors interact in terms of the acceptability of treatment. This study used patient interviews following acupuncture treatment for back pain to identify, understand and describe the elements that contribute or detract from acceptability of treatment.The study used semi-structured interviews. Twelve patients were interviewed using an interview schedule as a sub-study nested within a randomised controlled trial of acupuncture for chronic back pain. The interviews were analysed using thematic analysis.Three over-arching themes emerged from the analysis. The first entitled facilitators of acceptability contained five subthemes; experience of pain relief, improvements in physical activity, relaxation, psychological benefit, reduced reliance on medication. The second over-arching theme identified barriers to acceptability, which included needle-related discomfort and temporary worsening of symptoms, pressure to continue treatment and financial cost. The third over-arching theme comprised mediators of acceptability, which included pre-treatment mediators such as expectation and previous experience, and treatment-related mediators of time, therapeutic alliance, lifestyle advice and the patient’s active involvement in recovery. These themes inform our understanding of the acceptability of acupuncture to patients with low back pain.The acceptability of acupuncture treatment for low back pain is complex and multifaceted. The therapeutic relationship between the practitioner and patient emerged as a strong driver for acceptability, and as a useful vehicle to develop the patients’ self-efficacy in pain management in the longer term. Unpleasant treatment related effects do not necessarily detract from patients’ overall perception of acceptability. Chronic low back pain is a problem in the UK. The results of the York Acupuncture for Back Pain trial(YACBAC) Evidence from a trialists’ collaboration which conducted a meta-analysis of nearly 18,000 cases of acupuncture for chronic pain conditions including non-specific back pain indicated that acupuncture for low back pain is more than a placebo, although the difference between true acupuncture and sham acupuncture is relatively modest. According to the MRC guidelines for the evaluation of complex interventions, an important part of an evaluation process is an exploration of the way in which the intervention under study is implemented, because it can provide valuable insight into why an intervention fails or has unexpected consequences, or why a successful intervention works and how it can be optimised. To extend our understanding of acceptability, we have used qualitative methods, based on in-depth interviews with patients who received acupuncture for chronic low back pain nested within a randomised controlled trial. Our aim has been to capture patients’ reports on their thoughts, attitudes and experiences of treatment and to understand and describe the elements that they ascribe to the acceptability, or not, of acupuncture.This research was a qualitative sub-study nested within the York Acupuncture for Back Pain Trial (YACBAC)(ISRCTN80764175) In a postal questionnaire at three months after randomisation, 133 participants reported on treatment effects of acupuncture. Of those, twelve interview participants were drawn as a purposive sample, designed to include a range of known patient characteristics: age and gender, previous experience of acupuncture treatment, and both good and less favourable treatment outcomes. All 12 participants approached agreed to participate in the study and consented to a one to one, face-to-face, audio-recorded, semi-structured interview in their own home, and were considered suitable to represent the diversity of known patient characteristics.Lucy Thorpe, a research associate experienced in investigating acupuncture for back pain and depression and trained in conducting qualitative research recruited and interviewed all 12 participants, and Mike Fitter, a research consultant provided additional supervision.The interview opened with an introduction designed to draw out the participants’ account of treatment received as part of the trial, followed by prompts from a prepared topic guide  to eliciAn inductive thematic analysis following the methods of Braun & Clarke 2006 Three over-arching themes were identified and developed from the codes, The data was checked independently by co-author HM, and the coding and identification of subthemes were discussed and developed collaboratively between AH and HM throughout. The subthemes are illustrated with quotes that embody the participants’ experiences embedded within the analytical narrative, as suggested by Braun and Clarke 2006). Additional quotes that support each subtheme within the over-arching themes are set out in 006. AddiThe patients interviewed were 2 men and 10 women, purposively sampled to reflect the diversity of known characteristics across all participants in the trial. In the three-month questionnaires, which were completed at around the same time of the interviews, all study participants reported their health as fair to excellent, and the majority reported satisfaction with the acupuncture they had received. Only half of the patients who were interviewed reported satisfaction with the level of their back pain at three months.Three over-arching themes pertaining to the acceptability of acupuncture treatment were identified. The first over-arching theme entitled “Facilitators of acceptability” contained five subthemes; reduction in symptoms, improved physical activity, relaxation, reduction of psychological symptoms and reduced reliance on medication (Table1). The second over-arching theme entitled “Barriers to acceptability” encompassed four subthemes: needle-related discomfort, temporary worsening of symptoms, and tiredness, and the pressure to continue treatment with its’ potential financial cost (Table2). The third over-arching theme entitled “Mediating factors” comprised pre-treatment mediators , and treThe first facilitator of acceptability of treatment to be identified from the coding was the subtheme “reduction in symptoms of low back pain"(Table1). Two patients reported experiencing a reduction in pain symptoms from the first treatment session. More commonly, the pain relief became apparent gradually, following a trajectory over a period of several weeks. For example, several patients reported that they noticed a reduction in symptoms of low back pain about 4–6 weeks into treatment.“I had gone at first where it ached for two or three sessions, and I thought, this is not going to work, and then on the fourth session it was a lot easier. It was either the fifth or the sixth session when it was severe, and after that great. Each time I went then I got better and better. It got to the last one and I thought well really I don’t need it”. (p10)the nerves have come back to life” (p7). Most patients still experienced a degree of pain during specific household or work related tasks.Through the patients’ descriptions of pain relief, different types of pain were identified; commonly, severe pain was referred to in threatening terms such as sharp, stabbing, burning, whilst dull and aching pain was considered more tolerable. Two patients reported a reduction in their severe pain, to leave a dull aching, which they considered a good outcome. The relief from constant pain was reported in some cases, whereas for others, the specific types of pain changed in nature. Several patients reported a reduction in the frequency of radiating nerve pain or sciatic pain, bodily dissociation and numbness associated with back pain. One patient graphically described improvement as a sensation of energy flowing, warmth generated, and ““I don’t have constant pain like I did before, I know when I do certain things I'm going to get pain, but I don’t have it constantly which is a big difference to me in my life” (p12)The reduction in painful symptoms was not limited to low back pain; two patients reported that their chronic knee pain had been relieved, and another patient was pleased that her shoulder pain was treated during the course of treatment. In summary, the perceived reduction in the symptoms of back pain appeared to facilitate the acceptability of acupuncture.A second subtheme to facilitate acceptability of treatment was the improvement in energy levels and physical functioning. For the majority of patients the awareness of the reduction in daily pain became apparent through their ability to increase physical activity. Several patients compared their levels of activity before and after acupuncture. Their descriptions allude to the debilitating nature of chronic pain and illustrate how pain regularly interrupted everyday tasks, whereby short periods of rest were necessary in order to complete the task in hand. Over the course of treatment, several patients noticed an increase in their level of energy, which enabled them to complete daily chores more easily.“My energy level has increased. I can now cook a meal without having to lie down every couple of minutes in between doing something, which is better”. (p5)The salience of improved physical function differed; for one patient the ability to conduct self-care and simple activities of daily living were a very positive aspect. For several others the improvement in energy levels meant they could engage in beneficial exercise, an aspect that helped to focus the patient on their abilities rather than disability. This served to reduce frustration and, for some, led to being able to engage in gentle exercise activities to help regain strength and fitness. These positive outcomes in functioning were a welcome effect of the treatment.“You can get about; you can do things you’re not just kind of stuck to a chair or confined to the house… I like to go swimming which you know I couldn’t do and I’ve done it since the treatment. I’ve been back swimming I do that, and I hoover up now, which I didn’t do before and I’ve done a lot of walking” (p8).A third facilitator of acceptability of treatment was a positive, and for some unexpected, side effect of treatment, namely relaxation. Within this subtheme, several patients reported feeling very relaxed whilst the acupuncture needles were in situ, although the interpretation of relaxation differed between individuals.“While I was there having the treatment I felt relaxed…it was just nice to be peace and quiet and just lay there… It’s a relaxant, it just levels you, it levels you an talking relaxes you so that you’ve got time…you walk home floating” (p6)One patient cited a feeling of well-being, another reported being able to clear their mind during treatment. Two others actually fell asleep during treatment, with one person reporting feeling revitalised afterwards, an effect that continued into the following day.In summary, independent of whether there was a reduction in symptoms of pain, the feeling of wellbeing and relaxation during the treatment enhanced acceptability of the treatment.awful” pain experienced from neural symptoms was the cause of their low mood and tearful state (p11). Another acknowledged that stress was a major contributor to poor posture and other physical problems.The fourth subtheme of facilitators of acceptability was the psychological change experienced by some patients. Three patients linked the psychological components and physical components of chronic pain from different perspectives. One patient was clear in saying that the ““You get a load of stress in your head and your body doesn’t work properly, you know that stress is transmitted into your posture and everything else”. (p3)I’ve been listened to… I felt supported”. (p5) The ability to share the emotional or psychological aspects of chronic pain with a supportive practitioner, who could include these aspects in the treatment, was an important element of acceptability.This patient explicitly acknowledged the benefit of a holistic approach, where the acupuncturist was able to prioritise the treatment of his psychological symptoms. Unfortunately, for one patient the lack of ability to find suitable work due to chronic pain and the worry of the subsequent financial difficulty created extreme anxiety. Despite these worries the patient said, “The fifth subtheme identified as a facilitator of acceptability was the reduced use of medication. Several patients reported reliance on a combination of over the counter anti-inflammatory medication and prescribed analgesics. One patient recounted how he took analgesics as a prophylactic measure before engaging in exercise. Another used analgesics as an aid to sleep.“Prior to the acupuncture I was taking pain killers for my back to get to sleep at night, and then as the acupuncture progressed I didn’t take any for my back… I don’t like taking pills because of their effects on the body.” (p1)Most patients disliked being dependent on medication, citing unpleasant side effects, fear of addiction and ineffectiveness of commonly used analgesics as major drawbacks. Once acupuncture treatment had started, one patient stopped taking medication as a means of testing the efficacy of acupuncture. Several patients reported a reduction in the dosage and frequency of usage over the course of the treatment. Overall, reduced reliance on medication, along with reduced concern about unwanted side effects was a further contributor to the acceptability of acupuncture.The over-arching theme of barriers to acceptability comprised three subthemes related to treatment - needle-related discomfort, temporary worsening of symptoms, and tiredness - and a further subtheme on the pressure to continue with treatment with its potential financial cost .The first barrier was associated with needling discomfort. Discomfort due to needling varied across several patients; in most cases the type of treatment reactions reported were transient and mild.“Sometimes the needles themselves, when they put them in a certain point, they twist them and you get a sharp pain, and they do it again till it’s a kind of achy pain” (p5)One patient described a possible needling injury; one of her fingers twitched for four days after treatment and she/he was concerned that a needle had hit a nerve (p6).Another patient reported finding the treatment somewhat painful at times, but acknowledged that subsequent physical activity may have contributed to their discomfort.Two patients reported an unpleasant worsening of back pain symptoms after treatment, which lasted into the following day, and was relieved by taking paracetomol. One patient had been warned of the possibility of a reaction. The warning helped to reduce the patient’s concern and enabled them to view the reaction as an acceptable temporary discomfort with potential for overall improvement (p11). In contrast, warning of a possible reaction led the other patient to assume that the discomfort they experienced was entirely due to the treatment. They did not link the worsening of their symptoms to the effects of an extended car journey taken immediately after treatment.“I got the most awful back-ache in the car…really really bad backache. I ended up taking paracetomol that night. I think it was a temporary thing, a reaction to the acupuncture ‘cos in fact she warned me I may get an adverse effect to it to start with and of course I did”, (p4)Three patients felt extremely tired during the earlier sessions of the course of treatment. For one this was quite unexpected and inconvenient when lasting into the following day. In contrast, the second patient found the tiredness difficult to cope with initially, but later construed this reaction as an acceptable part of the healing process. The third patient successfully managed the situation by carefully planning appointment times. In doing so, the tiredness they experienced became part of their relaxation routine, and was viewed as recovery time.“I used to feel very tired… It was just a progression maybe of just your body saying you know you needed time to heal…I intentionally used to make my appointments later on in the day so I could come home and relax.” (p9)Several patients had previous experience of acupuncture and expected minor discomfort as an acceptable risk as part of the treatment. Although some patients continued to experience unpleasant reactions in later sessions, they had also experienced some benefit and persevered with the course of treatment. For a minority, these reactions detracted from the overall acceptability of the treatment, particularly where any overall benefit from treatment was less than expected.The fourth barrier to acceptability was the pressure to continue with treatment after the course of treatment paid for by the YACBAC trial had ended. None of the twelve people interviewed reported 100% pain relief without later recurrence of some of the back pain symptoms. Several patients were still in pain at the end of the 10 session course and reported that their acupuncturist had suggested one or two (or more) treatments as a private patient. Two patients welcomed the opportunity to continue. Another, who had not experienced pain relief felt unsure, but had appreciated the care and concern they had received and agreed to pay for additional sessions in the hope that it would work eventually.“She suggested it; it was her who suggested five more because she thought… she was hoping we would have cracked it really in five more sessions. I mean that must have been at the time when we were still feeling there was some improvement being maintained”. (p12)Two more patients would have liked to continued treatment, or would have considered treatment in the future, but were constrained by the financial cost of each session. Another patient tried to have the treatment continued via the GP but was told that funds were not available. In summary, patients found the cost of treatment more acceptable if they were experiencing some benefits, however, where the benefit was in question, or if they felt pressured to pay or could not pay, then the pressure to continue treatment and the potential financial cost of ongoing treatment were not acceptable.The third over-arching theme is that of mediating factors, which could potentially influence a patient’s behaviour, experience and perception of treatment in either positive or negative ways. Pre-treatment mediating factors related to aspects of expectation and previous experience . Two treExpectation of efficacy varied; six patients with previous experience of acupuncture felt that it might be helpful. For those without previous experience, two patients expressed doubt, and were influenced by the attitudes and experiences of others, one had read extensively and was very positive. Another felt excited at the prospect, but realised that the effect may be limited; one was convinced that belief was the key to efficacy. Most patients welcomed the opportunity to try acupuncture because their pain was severe, and they disliked taking medication. Only one patient, based on previous experience, offered an explanation of how he expected acupuncture to work:“with acupuncture it tends to keep the energy flowing through everything so it can obviously work better…if you’ve got energy going through properly which is what acupuncture does really, it controls these hidden energy lines which goes through and activates or deactivates muscles really or invigours(sic) them, so if you can organise that and get that kind of thing balanced then your back’s going to be straight and that’s how I think it works for me anyway” (p3).Time, the first mediating subtheme, represented a component of treatment that had a multifaceted impact that underpinned all aspects of the treatment process. The majority of patients interviewed enjoyed the time spent within an acupuncture consultation and contrasted it with that of a GP consultation. The acupuncture consultation was found to be more acceptable by several patients because it allowed them time to fully explain their experience of pain, receive individualised treatment for their back pain and other concurrent physical and psychological symptoms within the same consultation.“It’s totally for you, not for anybody else, totally for you and its lovely to have the attention instead of being on this five minutes list at a doctors and they don’t listen. They’ve got to listen to you and she’s interested”. (p6)One patient reported her enjoyment of the acupuncture session as a personal time to relax and reflect. In contrast, another patient who had a pressing workload found the treatment too time consuming for the pain relief gained and resented setting time aside to attend sessions. Even where GPs had given a diagnosis, prescribed several medications and made a referral to a physiotherapist, the brevity of the GP consultation was the overriding memory for most patients. For most people interviewed, the disparity in the time allowed for the GP consultation enhanced the perceived acceptability of the acupuncturists’ consultation.It’s a very nice sort of atmosphere there all friendly there and very relaxed. It’s not like sitting in the doctor’s waiting room you know pretending not to look at each other and waiting… You know it’s completely different … well it’s holistic compared to hustle-istic in the doctors. (p3)Underpinned by the subtheme of time, the second mediating factor was the subtheme of the therapeutic alliance. On a superficial level, three patients reported that their acupuncturist was kind, considerate and friendly. For two patients the development of good rapport and a trusting bond were key components of the therapeutic alliance and instilled faith in the acupuncturist’s abilities.“She’s well trained to do things, she’d know what she was doing… they are more thorough in examining you and ironing out your problems” (p5)For one patient, the level of courtesy and privacy was a special feature of the acupuncturist’s care. Two patients also comment on the acupuncturist’s care, concern and understanding of their condition compared to a perceived lack of sympathy from their doctor. Although one patient considered their doctor enthusiastic and sympathetic, the patient still lacked confidence in the doctor’s knowledge of treatment for back pain.“I think, with backs, GPs just don’t know what they are talking about. They just don’t know. You have to go to someone that is a specialist… if I do need to go back then I shan’t go to my GP” (p10)In contrast, where an acupuncturist was working in a multi-bed setting in a college clinic and moving between several patients at a time, the attention was not as personal, and the patient was left to glean information from passing acupuncture students.In summary, for most patients the provision of sufficient time and one-to-one attention clearly facilitated the development of the therapeutic relationship and contributed to the acceptability of the treatment.The third component within the theme of mediating factors was the provision of appropriate lifestyle advice. For the majority of patients, lifestyle advice was a common feature in consultations within both acupuncture and GP care. Patients were offered lifestyle advice related to their acupuncture diagnosis over the course of treatment. For several patients, the supportive encouragement from the acupuncturist helped them to engage in gentle exercise and regular activity according to their individual ability and with realistic expectations. In contrast, one patient seemed to be irritated with advice on exercise as at the time they regularly engaged in exercise that they considered appropriate to help them regain function and mobility. Three patients received dietary advice to lose weight, whereas another was offered individualised dietary advice to help them understand the importance of warm and cold foods in relation to their traditional Chinese diagnosis. Several patients received advice from the acupuncturist about their posture when walking:“She did give me two exercises to do with my hips which I have tried to do. She also talked to me about trying to look at myself in the mirror and see, try to be aware of my posture and also try to walk… keep my hips mobile and keep them moving in the right way really. So it’s been more to do with physical posture and things like that” (p11)learned me an awful lot” (p10).Two patients were advised to take more rest. One of these was specifically asked to do exercise to strengthen their back muscles but very clearly not to go beyond the point where the pain would get worse. The second was advised not to do anything, and to take it easy, and the patient summed up that “I wouldn’t say they .Overall, lifestyle advice was reported to be more acceptable when the acupuncturist provided it gradually, over the course of treatmentThe fourth mediating factor was the subtheme of the patients’ personal involvement in their own recovery. Three people reported that the treatment had brought them to an acceptance of their back pain. Two of those accepted that there was always going to be a certain amount of pain, but they could live with that. Another two patients became more aware of their fragility, but managed their back pain by maintaining personal vigilance of their posture and engaging in specific strengthening exercises.Two patients reported regaining a strong sense of control of their life and cited taking personal control as a key feature of their ongoing recovery, and the importance of setting time aside for themselves. Although acupuncture was not particularly effective for another person, they felt better placed to seek other treatment rather than putting up with back pain. In contrast, two people knew what steps to take in order to manage their back pain, but were unwilling to make changes. One other patient felt that he had taken all lifestyle steps possible to ensure a good recovery, and though capable of lifting heavy objects, he remained fearful of taking a labouring job that might lead to re-injury. In summary, for most patients, the taking of responsibility and being supported to gain control were potential facilitators of acceptability.“The start of curing yourself is to take steps to do something about it. That’s an acceptance, you know something’s wrong with you and you’ve got to get it sorted out. It does help to create a positive attitude. I deliberately altered me posture, trying to get it back over a year or two”. (p3)The results of this study show that acceptability of acupuncture for patients is based on a complex and multifaceted appraisal of the treatment, which incorporates potentially positive and negative experiences and perceptions. The therapeutic relationship between the practitioner and patient appears to be a strong driver of acceptability, but not the only reason. In addition to offering care and compassion, the supportive therapeutic alliance is a useful vehicle to promote learning, and to develop the patient’s self-efficacy in pain management, two aspects that might contribute towards a beneficial outcome and its maintenance. In this study, patients reported a range of beneficial outcomes and drawbacks of treatment. However, the judgment on how each of the benefits and drawbacks contributed to acceptability varied with the patients’ individual experience. These qualitative findings should be considered in the context that the quantitative data showed acupuncture had a clinically and statistically significant effect in reducing chronic pain. An understanding of the underlying mechanisms of effectiveness was not considered important by patients in their reports on efficacy or acceptability of treatment.Qualitative studies nested within randomised controlled trials are particularly suited to exploring in depth the reasons why an intervention might be successful or not. Our use of in-depth interviews provided a deep understanding of what acceptability means to patients receiving acupuncture for low back pain and presented rich detail of how they interpret their experience of treatment. The bottom-up process of thematic analysis was conducted following the steps recommended by Braun and Clarke. Our findings provide insight into a key factor related to effectiveness, namely acceptability of treatment. Acceptability is an important factor because it will impact on the take-up of the treatment offered and the compliance or willingness to see the course of treatment through. We have reported on patients’ experiences of acceptability, whether the outcomes from acupuncture were beneficial or not. A strength of our study is that we have been able to qualify the quantitative results on effectiveness with our data on acceptability. A better understanding of the underlying factors that impact on acceptability and effectiveness enhances our understanding of the potential transferability of the intervention to practitioners of acupuncture across the UK. For example, our study adds to the quantitative data by providing an understanding on the impact of the patient-practitioner relationship on the acceptability of acupuncture treatment, and what steps the practitioner and patient might take to maximise the likelihood of acceptability for the patient.A limitation of the study was the small number of interviews, however, the coding for each theme was congruent across the majority of the sample and data saturation occurred within six interviews. Individual differences were included in the results to illustrate contrasts where they occurred, and to avoid bias in representation. The researchers AK and HM were in accordance with each other on the data extracted and their interpretation; however lack of wider consultation may be a potential source of bias. A further limitation was the minimal integration with the quantitative data available from the YACBAC trial. Willingness to have acupuncture again has been found to be a quantitative indicator of acceptability among patients with low back pain. The expectation of pain relief is reported to have a significant impact on outcomes in patients with chronic pain. An awareness of gaining greater control over back pain enhanced the acceptability of the treatment for some patients. Within the therapeutic alliance, the development of the learning processes appeared to engender greater efficacy in the patients’ personal management of back pain. These findings are consistent with practitioner reports from two other qualitative studiesAcceptability of acupuncture treatment appears to increase when the combined processes of care lead the patient to accept responsibility for their ongoing back care, and helps to shift their focus from pain elimination to the restoration of function. This shift in focus creates of an opening for a transition from the biomedical model which focuses on healing through techniques, toward the ‘healing through adaptation,’ based on a biopsychosocial explanatory model of back pain The time allowed for each acupuncture session was an important contributor to acceptability, however, the time-frame needed for the processes of treatment to occur is not possible within the consultation time available within the GP surgery. Acceptability of acupuncture treatment for low back pain is associated with a complex appraisal of the treatment processes and outcomes, and reflects the quality of the care received. Acceptability is enhanced by beneficial physiological and psychological outcomes, and the development of learning processes that engender personal responsibility and increased self-efficacy in the management of low back pain. Dissatisfaction with the amount of pain relief received, and unpleasant treatment effects do not necessarily detract from the patients’ overall perception of acceptability of the treatment.Appendix S1TOPIC GUIDE.(DOC)Click here for additional data file.Appendix S2COREQ 32-ITEM CHECKLIST.(DOC)Click here for additional data file.


Inguinal hernia is one of the most common male diseases all over the world with an incidence rate of 18-24% throughout life. Chronic inguinal pain is one of the complications that prolong return to work time.The main aim of this study was to determine the effect of ilioinguinal neurectomy on postoperative chronic pain (PCP) in patients that underwent open inguinal hernia repair via the Lichtenstein method.In this randomised controlled clinical trial, male patients with unilateral inguinal hernia were randomized into two groups: 74 cases in the preserved-nerve group and 66 cases in the nerve-excised group. The method of herniorrhaphy was the classic Lichtenstein method. Pain and numbness were evaluated at 1 day, 1 week, 1 month, 6 months and 1 year after surgery via visual analogue scale (VAS) system. We used SPSS ver.16 for analysis.All patients were male with mean age of 39.1 years (with a range of 18 to 68 years). The follow-up rate was 100% after 1 year. Pain severity was significantly lower in nerve-excised patients at 1 day, 1week, 1 month and 6 months after surgery; but it was not significant after one year, although overall pain severity was low. Numbness was significantly higher in excised patients at all endpoints .Ilioinguinal nerve excision at the time of inguinal hernia repair decreased post-surgical inguinal pain, and it can be used as a routine method in herniorrhaphy. Chronic post-herniorraphy pain is among the most frequent complications after inguinal hernia repair. In some patients it can be disabling. The prevalence of postoperative chronic pain (PCP) ranges from 0 to 63%, regardless of the type of hernia repair and may be secondary to a multitude of disorders including the post-herniorrhaphy pain complex syndrome . The iliNociceptive or neuropathic pain syndromes related to hernia surgery have to be differentiated from other sources . ChronicThe underlying causes of PCP include neuropathic and non-neuropathic conditions. The neuropathic causes are nerve compression by perineural fibrosis, suture, staples, prosthetic material and nerve injury during surgery. Walking and hyperextension of the hip trigger this type of pain. The non-neuropathic (somatic pain) causes are periosteal reaction, scar tissue, mechanical pressure of folded mesh called ‘meshoma’ and visceral pain (encountered only on ejaculation); Neuropathic causes, especially chronic nerve irritation, are considered as an important cause of moderate or severe PCP . In a meNon-identification of the ilioinguinal nerve during open inguinal mesh repair carries a significant risk for the development of pain lasting longer than 3 months . The iliThe main aim of this study was to evaluate long-term and short-term outcomes  following ilioinguinal nerve-excision compared to nerve-preservation.This was a randomized controlled clinical trial on male patients with uni-lateral inguinal hernia admitted to our hospital. Informed consent was obtained before surgery from hospital-admitted patients. Patients were randomized in two groups: 74 cases in preserved-nerve group and 66 cases in nerve-excised group. Pain and numbness were evaluated at 1 day, 1 week, 1 month, 6 months and 1 year after surgery with VAS system. We used SPSS ver.16 for analysis. Pain and numbness was assessed before the operation and on days 0, 1, 7, and 6 months and 1 year postoperation.Between june 2009 to july 2010 patients consecutively diagnosed with primary unilateral inguinal hernia and scheduled for Lichtenstein’s operation were included; 140 patients older than 18 years who suffered from primary inguinal hernia were randomized into two clinically comparable groups: 66 patients were in the nerve-excision group (group A), and 74 patients were in the nervepreservation group (group B). In group A, we performed Lichtenstein hernia repair and neurectomy; in group B, only Lichtenstein’s operation was performed. Patients with recurrent, bilateral, strangulated and incarcerated hernias and patients with history of diabetes mellitus, history of previous abdominal operation, opium addiction and cerebrovascular accident were excluded.Informed consent, including explanation of the risk of chronic pain, was obtained from all patients in an outpatient setting. We explained probable complications to all patients. Analyzed parameters included age, gender, preoperative pain, post-operative pain, post-surgical complications , physical activities, type of hernia (direct or indirect) and type of anesthesia. The primary outcome was the incidence of disabling pain and numbness at 6 months and 1 year post-surgery. Also surgical incision length on the first day after surgery was measured with a ruler. And returnto-work time was recorded. Comparative data about the groups are shown in This project was approved by the University Research Council and by the local ethics committee. We performed ilioinguinal neurectomy in this study because this nerve always lies between the mesh and the muscular layer after anterior mesh repair, and fibrous tissue can cause nerve entrapment. In this study, the inguinal hernia of the patient was repaired using the open tensionfree mesh technique as described by Lichtenstein et al. Surgical technique was the same in both groups, and surgery was performed with the patient under spinal and general anesthesia. Local anesthetics were not used. Postsurgical analgesic medications were opiods in the early postsurgical hours and then with nonsteroidal antiinflammatory drugs.Hernia repairs were performed by two experienced surgeons. In group B, tension-free hernia repair was performed and Polypropylene of 7×15 cm in size was secured to the floor of the inguinal canal by 2/0 nylon stitches. The ilioinguinal nerve mentioned above was identified and preserved. Then, the external oblique fascia was closed above the spermatic cord, ilioinguinal, iliohypogastric and genital nerves. In group A, the ilioinguinal nerve was cut sharply with a blade 1 to 2 cm lateral to the internal inguinal ring, and 3 to 4 cm of the nerve was excised. Neither electrocautery nor suture material was used in cutting the nerve. To control of bleeding, direct pressure was used when needed. After the transection of the nerve, its proximal end was implanted into the internal oblique muscle without tension and drains were not used. A polypropylene mesh was placed as described. We confirmed the division of the ilioinguinal nerve by histopathologic examination.The patient and the person who completed the forms did not know to which group the patient belonged (study group or control group). The surgeon preserved or excised the nerve according to patient number and the randomization table (double blind). This was not written on the surgery report but could be determined later using the patient number and the randomization table. Severity of pain and hypoesthesia were determined at mentioned endpoints after surgery. VAS was used as a standard scale for rating pain. In addition to pain assessment, numbness was recorded as well. The reliability and validity of this scale among other pain scales has been acceptable. Follow-up was performed by an assessor who was unaware of the procedure and the patients; therefore, the study was conducted in a double-blind fashion. Chi-square and T-Test were used for analysis of data and differences were considered significant at P < 0.05. Collection and analysis of the data was performed using SPSS statistical software version 16.0; all patients were visited at the outpatient clinic at determined endpoints were examined by a physician and a general surgeon who were not aware of the surgical intervention.In this study, 140 patients were enrolled ; 66 patients (47.1%) were in nerve excision group and 74 patients (52.9%) were in nerve preserved group; All patients attended the follow up examinations and none of them were excluded at this stage. The mean age of patients was 39.1 ± 11.9 with a range of 18 to 68 years. The mean age in the nerve-excision group was 39.5 ± 13.5 and in the nerve-preserved group was 38.8 ± 10.3; 65 patients were university graduates (46.4%) and the remaining patients (53.6%) were high school graduates. The job of most patients was related to the military forces (44.3%); 19.3% of patients were students, 8.6% were farmers and 12.1% were worker; 84 patients (60%) had right inguinal hernia and 56 patients (40%) had left inguinal hernia. In nerve-excision group 60.4% of patients had right inguinal hernia and 39.4% had left inguinal hernia. Most common complaints were pain and protrusion (both together and concurrently) in the groin area (51.4%); thereafter, protrusion and pain (as a separate complaint) were present in 25.7% and 22.9% of patients respectively.In the short-term and long-term follow up, there was no significant difference between pain severity after the surgery and chief complaint of patients before surgery. Mean pain severity in patients with pain complaint and in patients with protrusion was 3.16 ± 0.95 and 2.97 ± 1.25, respectively; in patients with both pain and protrusion together, were 2.79 ± 1.12; 22.7% of patients in nerve excision group and 24.3% in nerve preserved group had a background of cardiovascular disease; 110 patients (78.6%) underwent spinal anesthesia and 30 patients (21.4%) underwent general anesthesia.Overall, the mean incision length was 7.1 cm. The minimum length of incision and maximum length of incision were 5 cm and 10 cm respectively. The average incision length was 7.4 cm in nerve-excision group and 6.9 cm in nerve preserved group. Preoperative mean pain severity on the VAS was 4.48, with the minimum and maximum of 3 and 6. The mean preoperative pain in nerve-excised group was 4.3 and in nerve-preserved group was 4.6. In the short and long term follow ups, there were no significant statistical differences between age and post-surgical pain; mean pain in patients less than 40 years after first week was 2.91 ± 0.99 and in older than 40 years was 2.93 ± 1.28; and mean pain in patients less than 40 years after one year was 0.19±0.39 and in older than 40 years was 0.18 ± 0.39. Mean pain severity one day after surgery in nerve-preserved group and in nerve-excised group was 8.5 ± 0.16 and 7.6 ± 0.7, respectively.Mean pain severity scores a week after surgery in nerve-preserved group and in nerve-excised group were 3.7 ± 0.7 and 2.03 ± 0.7, respectively. Mean pain severity scores a month after surgery in nerve-preserved group and in nerve-excised group were 1.89±0.6 and 0.56±0.5, respectively. Mean pain severity scores six months after surgery in nerve-preserved group and in nerve-excised group were 0.9±0.6 and 0.3±0.4, respectively. Mean pain severity scores a year after surgery in nerve-preserved group and in nerve-excised group were 0.22 ± 0.44 and 0.15 ± 0.3, respectively. Mean numbness scores (measured via VAS) a day after surgery in nerve-preserved group and in nerve-excised group were 0.19 ± 0.3 and 0.41 ± 0.4, respectively. Mean numbness scores a week after surgery in nerve-preserved group and in nerve-excised group were 1.3 ± 0.5 and 2.86 ± 0.7, respectively. Mean numbness scores a month after surgery in nerve-preserved group and in nerve-excised group were 1.91 ± 0.7 and 4.61 ± 0.7, respectively. Mean numbness scores six months after surgery in nerve-preserved group and in nerve-excised group were 2.15 ± 0.7 and 5.18 ± 0.7, respectively. Mean numbness scores one year after surgery in nerve-preserved group and in nerveexcised group were 1.3 ± 0.7 and 7.52 ± 0.7, respectively. Mean return to work time (according to patient’s job) was 5.2 days. Mean return to work time in nerve-preserved group and in nerve-excision group was 5.7 ± 0.9 and 4.6 ± 0.8, respectively. Post-surgical complications in both groups were in Residual pain should be viewed as an essential endpoint when assessing the outcome of hernia surgery. After 24 to 36 months, nearly 30% of the patients reported some form of pain or discomfort and close to 6% of all patients reported inguinal pain of such intensity that it disturbed their concentration in activities of daily life during the week preceding follow-up . The repIn a small randomized controlled trial involving 20 patients with a bilateral inguinal hernia; Ravichandran et al. evaluated the differences in the incidence of pain between the ilioinguinal nerve ‘preserved’ and ‘divided’ sides and did not find any significant difference in the pain and numbness between both sides . In anotIn Ravichandran et al. study, at 6 months postoperatively, pain was present in 1 of 20 patients (5%) on the nervepreserved side versus 0 of 20 patients (0%) on the nerve division side. Numbness was present in 0 of 20 patients (0%) on the nerve-preserved side versus 2 of 20 patients (10%) on the nerve divided side. No significant difference was seen in pain or numbness between the divided and preserved sides. Sensory loss detected by clinical examination was more common following the division of the nerve compared with preservation. Elective division of the ilioinguinal nerve during inguinal hernia repair does not appear to be associated with a significant increase in postoperative symptoms . Based oEvaluation of pain was subjective in our study and this is one of the limitations. Another limitation was that the long-term effect of ilioinguinal neurectomy was not investigated. Larger clinical trials with more patients and longer follow-up are warranted to study the long-term effect of prophylactic neurectomy in patients undergoing Lichtenstein repair. And finally we showed that prophylactic neurectomy reduces the incidence of postoperative chronic pain. After the exclusion of patients with preoperative pain the CP rates were 13.2% and 13.8%, in Group A and B, respectively. Our policy was to identify and preserve intact nerves and divide damaged nerves or nerves that were at risk for injury. Ilioinguinal nerve excision at the time of inguinal hernia repair decreased post-surgical inguinal pain and it can be used as a routine method in herniorrhaphy. This procedure is safe and easy to perform during anterior mesh repairs. However, further studies are needed to demonstrate the effectiveness of this procedure in various settings; but this study recommends that Ilioinguinal neurectomy should be considered as a routine surgical step during open mesh hernia repair.


Previous studies in patients with hip and knee osteoarthritis (OA) have advocated the relevance of assessing the number of painful joint sites, other than the primary affected joint, in both research and clinical practice. However, it is unclear whether joint-pain comorbidities can simply be summed up.A total of 401 patients with hip or knee OA completed questionnaires on demographic variables and joint-pain comorbidities. Rasch analysis was performed to evaluate whether a sum score of joint-pain comorbidities can be calculated.Self-reported joint-pain comorbidities showed a good fit to the Rasch model and were not biased by gender, age, disease duration, BMI, or patient group. As a group, joint-pain comorbidities covered a reasonable range of severity levels, although the sum score had rather low reliability levels suggesting it cannot discriminate well among patients.Joint-pain comorbidities, in other than the primary affected joints, can be summed into a joint pain comorbidity score. Nevertheless, its use is discouraged for individual decision making purposes since its lacks discriminative power in patients with minimal or extreme joint pain. Previous studies in patients with hip and knee osteoarthritis (OA) advocated the relevance of assessing the number of painful joints, other than the primary hip or knee joint, in both research and clinical practice -3. JointTo date, the use of joint counts to indicate the level of joint-pain comorbidity in people with knee or hip OA is common -5. By siTherefore, the aim of this study was to examine the validity of summing painful joint sites in people with hip or knee OA.Data were used from a previous study, which examined the prevalence of joint-pain comorbidities in patients with a physician-based diagnosis of hip or knee OA . The patAt baseline, information was gathered on gender, age, body-mass index (BMI), and disease duration. In addition, the patients received a questionnaire within 14 days after their visit, assessing their joint pain at 19 joint sites, including the hands, wrists, elbows, shoulders, cervical spine, thoracic spine, lumbar spine, hips, knees, ankles, and feet. Patients had to indicate whether they experienced symptoms from particular joints and whether these symptoms were present for more than half of the time during the last month. If both questions were positive, the joint was counted as being painful.The study was approved by the Institutional Review Board of the University Medical Centre, Nijmegen and all patients enrolled in the study gave informed consent.Whether the joint-pain comorbidities can simply be summed up was evaluated using Rasch analysis. A feature of the Rasch model is that it assumes all items to be equally discriminating . As a reIn order to perform Rasch analysis, the data must conform to a number of underlying assumptions of the Rasch model -10 incluThe first assumption, unidimensionality, was tested with a principal component analysis of the tetrachoric correlation matrix in SPSS Statistics 18.0, using oblimin rotation. The scale was assumed to be sufficiently unidimensional (i.e. there is one dominant underlying factor) if the ratio of the first and second eigenvalue was >3 : 1 .The second assumption concerns the model’s ability to reflect the true relationship among the underlying construct and the item responses -10. ThisThe final assumption assumes that the items are not further associated with each other once the Rasch factor is taken into account. Violation of this assumption might point to response dependency  or to multidimensionality of the scale ,12. ItemIn case the Rasch assumptions were satisfied, joints were checked for differential item functioning (DIF). DIF is present when subgroups of patients with similar levels of the measured underlying construct (i.e. the degree of joint-pain comorbidity as measured by summing the number of painful joints) give different responses (i.e. painful or not painful) to a specific joint ,10. DIF Finally, the performance of the sum score was examined by evaluating its test information function with associated reliability levels; showing whether precise and reliable joint-pain comorbidity scores can be obtained across the range of joint pain comorbidity severity. Reliabilities >0.7 were deemed acceptable for group use . In addiRasch analyses were performed using Winsteps, version 3.65 .2. The majority of the participants had a K/L grade of ≥ 2 and a disease duration of >5 years, respectively 76% and 61%. Mean (SD) pain levels were 45 (21) points for the hip group and 50 (20) points for the knee group, as measured with the Hip disability and Osteoarthritis Outcomes Score and Knee Injury and Osteoarthritis Outcome Score respectively [Data were collected from 401 patients (58% n=231] women and 42% n=170] men), of which 71% were referred for knee OA and 29% for hip OA. The average (SD) age of the study sample was 58 (13) years, with an average (SD) body mass index of 27 (5) kg/mectively ,17. More0 men), o31 women ectively .The test of unidimensionality showed that the ratio between the first and second eigenvalue was 9.701 : 2.117, which is >3 : 1. Thus, the 19 items formed a sufficiently unidimensional scale for Rasch analysis.The results of the Rasch analysis showed an acceptable fit of the comorbid joints (i.e. other than the primary affected joints) to the Rasch model Table . Infit MAlthough some Infit and Outfit values fell outside the specified range for a number of joints, these analyses were based on very strict sample size corrected Infit and Outfit statistics. A more commonly applied, less strict, rule of thumb is that both the Infit and the Outfit MNSQ are allowed to be somewhere between the 0.7 and 1.3. When these values were held against the data, fit was even better with none of the joints showing Infit MNSQ values <0.70 or >1.30 and only 5 joints showing Outfit MNSQ values <0.70 or >1.30.r > 0.70, within a range of -1.04 to +1.18, corresponding to the presence of 5 to 14 painful joints. Although this indicates that the instrument can discriminate well between patients within these wide range of joint scores, it only covered 11.2% of the patient sample since most patients (86.8%) had less than 5 painful joints. The instrument’s discriminative power for this large majority of patients with few complaints is much lower, diminishing the instrument’s usefulness.The test information function Figure  shows thThe past decades show a marked increase in item response theory applications within the rheumatic field . Item reComorbidity is very common in people with OA ,22 and iThe results of this study showed that it is valid to sum the number of painful joint sites to assess joint-pain comorbidity in hip or knee osteoarthritis. However, prudence is in order when using this instrument for treatment decisions on an individual level.OA: Osteoarthritis; BMI: Body mass index; MNSQ: Mean square; DIF: Differential item functioning.None of the authors have financial, commercial, or other associations that might pose a conflict of interest in connection with the work.LS was responsible for the conceptualization of the manuscript. EVDE and TH were responsible for data collection. PTK, TH, EVDE, and MVDL supervised the whole study and the interpretation of the results. All authors critically evaluated the manuscript, contributed to its content, and approved the final version. LS and TH take responsibility for the integrity of the work as a whole, from inception to finished article .The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/14/234/prepub


No consensus exists on how rehabilitation programs for lumbar discectomy patients with persistent complaints after surgery should be composed. A better understanding of normal and abnormal postoperative trunk muscle condition might help direct the treatment goals.A three-dimensional CT scan of the lumbar spine was obtained in 18 symptomatic and 18 asymptomatic patients who had undergone a lumbar discectomy 42 months to 83 months (median 63 months) previously. The psoas muscle (PS), the paraspinal muscle mass (PA) and the multifidus muscle (MF) were outlined at the L3, L4 and L5 level. Of these muscles, fat free Cross Sectional Area (CSA) and fat CSA were determined. CSA of the lumbar erector spinae  was calculated by subtracting MF CSA from PA CSA. Mean muscle CSA of the left and right sides was calculated at each level. To normalize the data for interpersonal comparison, the mean CSA was divided by the CSA of the L3 vertebral body . Differences in CSA between the pain group and the pain free group were examined using a General Linear Model (GLM). Three levels were examined to investigate the possible role of the level of operation.p = 0.009) independently of the level. The mCSA of the LES was significantly smaller in pain patients, but only on the L3 slice (p = 0.018). No significant difference in mCSA of the PS was found between pain patients and pain-free patients (p = 0.462). The fCSA of the MF (p = 0.186) and of the LES (p = 0.256) were not significantly different between both populations. However, the fCSA of the PS was significantly larger in pain patients than in pain-free patients. (p = 0.012).In lumbar discectomy patients with pain, the mCSA of the MF was significantly smaller than in pain-free subjects (The level of operation was never a significant factor.CT comparison of MF, LES and PS muscle condition between lumbar discectomy patients without pain and patients with protracted postoperative pain showed a smaller fat-free muscle CSA of the MF at all levels examined, a smaller fat- free muscle CSA of the LES at the L3 level, and more fat in the PS in patients with pain. The level of operation was not found to be of importance. The present results suggest a general lumbar muscle dysfunction in the pain group, in particular of the deep stabilizing muscle system. Following lumbar discectomy, residual complaints persist to some degree in 28%  to 74.6%As in nonspecific chronic low back pain (LBP) -11, the . Muscle atrophy has been scored on CT-images of patients with good and poor recovery 2 to 5 years after surgery for spinal stenosis or disc herniation [Previous studies have reported on the Computed Tomography (CT) quality of the back muscles of lumbar discectomy patients -14. Muscrniation . The MF rniation . Mayer erniation . They foTo our knowledge, differences in muscle quality of the isolated MF between lumbar discectomy patients with and without pain have not been studied yet.Therefore, the present study was designed to investigate possible differences in muscle condition of 3 trunk muscles, particularly the MF, in lumbar discectomy patients with pain and without pain. The muscles were examined at three levels to study the possible influence of the level of operation.After obtaining approval from the Ghent University Ethics Committee, lumbar discectomy patients with and without pain were included in the study. A volume CT scan of the lumbar region (L3 lower endplate to S1 lower endplate) was performed to screen for old and new lumbar disorders. In case of normal postoperative findings, reconstructions were made through the lower endplates of L3, L4 and L5 for measurement of the total and fat-free muscle cross-sectional area (CSA) of the isolated MF, lumbar erector spinae (LES) and PS on both the left and right side. Fat area was calculated as the subtraction of fat-free muscle CSA from total CSA.Thirty-six patients with a history of L5-S1 lumbar discectomy, participated in the study. They were divided into a pain-free postdiscectomy group (n = 18) and a postdiscectomy group with pain (n = 18), based on their pain history and the results of a Visual Analogue Scale (VAS) for pain. Pain-free patients had experienced no or occasional back pain following the operation. The cut-off point was set at 1.5 on VAS since 7 patients scored between 0.5 and 1.5 on VAS, stating that this score reflected no real pain, but rather awareness of their back .Disc resection was unilateral in 20 (56%) and bilateral in 16 (44%) cases. Time since surgery ranged from 12 months to 89 months (mean 59 months). All participants read and signed an informed consent form. Their clinical data are presented in table Overall exclusion criteria were lumbar scoliosis, hip disorders, pregnancy within the last year, a history of central neurological impairments, and major pathological conditions such as a malignant tumour or uncontrolled systemic disease. Patients with abnormal postoperative CT-findings were also excluded from the study. These abnormal findings included recurrent disc herniation or new disc herniation with compression of the spinal cord or nerve root compression, spinal stenosis, spondylolisthesis, spinal tumour or pseudomeningomyelocele, degenerative narrowing of the lateral recess with compression of neural structures, and stress fracture of the vertebral arch.Clinical evaluation of outcome included an interview and a neurological examination by an independent observer, and standard questionnaires (Quebec Back Pain Disability Questionnaire (QBPDS)-22, VAS A 4-slice CT-scan  was used at 140 kV and 200 mAs with a slice collimation of 1.25 mm and a pitch of 0.75. The patient was scanned in prone position from the lower endplate of the L3 to the S1 vertebral body, without contrast administration. Adjacent 5-mm reconstructions were made in a soft-tissue kernel . All scans were evaluated on a Leonardo  workstation by a single radiologist, blinded for the patient's complaints. Five-mm thickness reconstructions were made through the lower endplate of the L3, L4 and L 5 vertebral bodies in a standard fashion  was set at the borders of the PS (psoas major + iliac muscle), the PA  and the isolated MF  figure .The total CSA (fat+muscle) of the different muscles was measured. Next, fat-free muscle CSA was determined using a threshold technique (Osiris), in which the area occupied by pixels within the soft-tissue threshold limits (0 -250 HU) was selected. Fat CSA was calculated as the difference between total CSA and fat-free muscle CSA. The CSA of the LES was calculated by subtracting the MF CSA from the PA CSA. The CSA of the L3 vertebral body was measured to normalize the data: each CSA was divided by the CSA of this body, resulting in normalized fat-free muscle CSA data (mCSA) and normalized fat CSA (fCSA) data.All measurements were performed by the same examiner. Intratester reliability was assessed by repeated measurement of 20 of the 36 scans. The assessment of measurement repeatability showed good agreement between the two measurements for PS (ICC = 0.92), LES (ICC = 0.97) and MF (ICC = 0.96), indicating that the measures were reliable.Descriptive statistics were used to analyse patient characteristics and clinical findings.Mann-Whitney-U tests were performed to investigate differences in patient group characteristics. For each muscle investigated  a repeated measures analysis of variance with 3 factors was performed to investigate possible differences in mCSA and fCSA between pain-free and pain patients. The between subject factors were 'group' (with 2 sublevels: pain and no pain) and 'level of operation' (with 2 sublevels: L4 discectomy and L5 discectomy). The within subject factor was 'slice' (L3 slice/L4 slice/L5 slice).P < 0.05.The statistical analyses were performed with SPSS 15.0 software . Statistical significance was set at p < 0.001), MPI (p < 0.001) and TAMPA (p = 0.039) outcome scores were significantly higher in the pain group.The asymptomatic and symptomatic lumbar discectomy group did not significantly differ in age, gender, Body Mass Index (BMI), duration of pain before surgery and time elapsed since surgery table . QBPDS : the mean mCSA at the L3 slice was significantly smaller than on the L4 slice (p < 0.001) and on the L5 slice (p < 0.001); the mean mCSA on the L4 slice was significantly smaller than on the L5 slice (p < 0.001).No significant interactions were found between the factors. The factor 'group' (p = 0.009) was significant. The mCSA was smaller in patients with pain compared to pain-free patients. The factor 'level of operation' (p = 0.796) was not significant. The factor 'slice' was significant (Because a significant interaction was found between the factors 'group' and 'slice' (p = 0.049), comparisons between the two study groups were performed for each slice separately. Next, comparisons between slices were done for both patient groups. On the L3 slice, mCSA of the LES was significantly larger in pain-free patients than in pain patients (p = 0.016). On the L4 and L5 slice, no significant difference in mCSA of the LES was found between both patient groups.Although a significant interaction was found for the factors 'group' and 'slice', the analysis for both groups sepperately revealed the same results:p < 0.001); the mean mCSA at the L3 slice was significantly bigger than at the L4 slice (p < 0.001) and the L5 slice (p < 0.001); mean mCSA on the L4 slice was significantly larger than on the L5 slice (p < 0.001).the factor 'slice' was significant (The factor 'level of operation ' was not significant (p = 0.638).p < 0.001). Post hoc analysis revealed a smaller mean mCSA on the L3 slice compared to the L4 slice (p < 0.001) and to the L5 (p = 0.001) slice. There was no significant difference in mCSA between the L4 and L5 slice (p = 0.398). The factors 'group' (p = 0.462) and 'level of operation' (p = 0.427) were not significant.Repeated measures analysis of variance showed no significant interactions between the main factors. The factor 'slice' was significant (p < 0.001): the mean fCSA on the L3 slice was significantly smaller than on the L4 (p < 0.001) and the L5 slice (p = 0.001); the mean fCSA on the L4 slice was significantly smaller than on the L5 (p < 0.001). The factors 'group' (p = 0.186) and 'level of operation' (p = 0.146) were not significant.No significant interactions were found between the factors. The factor 'slice' was significant (No significant interactions were found between the factors. The factors 'group' (p = 0.258), 'level of operation' (p = 0.131) and 'slice'(p = 0.208) were not significant.p < 0.001): the mean fCSA at the L3 slice was significantly smaller than at the L4 slice (p = 0.001). There was no significant difference in fCSA between the L3 and the L5 slice (p = 0.054), nor between the L4 and L5 slice (p = 1.000). The factor 'level of operation' (p = 0.709) was not significantNo significant interactions were found between the factors. The factor 'group' (p = 0.012) was significant. The fCSA was larger in patients with pain than in pain-free patients. The factor 'slice' was significant , indicating that the cause of pain had been abolished during the operation. This was not entirely the case in the patients with persistent pain. The muscle abnormalities might therefore be the result and not the cause of their persistent pain. A more plausible explanation for MF atrophy at multiple levels and LES atrophy at the L3 level seems to be a pain-related inhibition phenomenon. Postoperative pain could have perpetuated the inhibition process that started at the occurrence of a symptomatic lumbar disc herniation. In the pain free patients, however, this was reversed by lumbar discectomy.For none of the CSAs examined was the level of operation found to be a significant factor. Consequently, the operation did not seem to be responsible for the muscle atrophy observed. This finding is in accordance with the study by Sihvonen et al. In patients with poor recovery 2 to 5 years after surgery for spinal stenosis or disc herniation, they found muscle atrophy not to be restricted to the level of operation, but rather attributed it to muscle disuse . MontesuBecause the TAMPA score for kinesiophobia was significantly higher in pain patients than in pain free patients, another hypothesis could be that back muscle deconditioning occurred as a consequence of fear avoidance in the patients with persistent pain. Back pain patients are more likely to avoid back extension movements than hip flexion movements, which explains why no atrophy was found for the mCSA of the PS. However, this muscle also showed signs of deconditioning as it contained more fat, which could be the result of some additive general muscle deconditioning in the pain patients.Since there are no data for healthy controls in the current study design, CT muscle quality of the pain free discectomy patients could not be compared with that of healthy controls. Questions remain concerning the presence of atrophy in pain free patients, which could for instance be influenced by the duration of pain preceding the disc surgery, or by back guarding to prevent recurrent LBP.The clinical relevance of the differences between the pain group and the asymptomatic group still has to be proven in future studies.A test-retest acquisition and consecutive measurements are necessary in order to estimate the reproducibility of the method. It was however not defendable to redo a 3D CT scan with 5000 Rad to this aim.Comparison of CT muscle condition of the MF, LES and PS in lumbar discectomy patients with pain and without pain long after surgery showed a smaller fat free muscle CSA of the MF at all levels examined, a smaller fat free muscle CSA of the LES at the L3 level, and more fat in the PS muscle in pain patients. The level of operation was not found to be of importance. The present results suggest a general lumbar muscle dysfunction in the pain group, and in particular of the deep stabilizing muscle system.The authors declare that they have no competing interests.KGWB participated in the study design, in collecting the data, the statistical analyses, and drafting of the manuscript. CT scan interpretation was performed by OV. VKS participated in collecting the data. PLC advised and assisted in the statistical analyses. CJJ and DCC participated in the study design. GGV coordinated the study. LAD participated in the study design and in the progress and drafting of the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/12/65/prepub