A nonsurgical intervention, interventional microadhesiolysis, was developed to release adhesions in joints and soft tissues. This paper introduces the procedure and evaluates the efficacy of the intervention for adhesive capsulitis of the shoulder.Ten patients (five men and five women) with primary adhesive capsulitis of the shoulder were treated at a chronic pain management center in Korea. Three specially made needles are used in interventional microadhesiolysis: the Round, Flexed Round, and Ahn's needles. A Round Needle is inserted on the skin over middle of supraspinatus and advanced under the acromion and acromioclavicular joint . A Flexed Round Needle is inserted two-fingers caudal to the inferior border of the scapular spine and advanced over the capsule sliding on the surface of infraspinatus muscle-tendon fascia. The capsule is released while an assistant simultaneously passively abducts the shoulder to full abduction (posteroinferior capsule release). An Ahn's Needle is inserted on the skin over the lesser tubercle and advanced under the coracoid process sliding on the surface of the subscapularis muscle (subcoracoid release).p < .01), the shoulder range of motion increased significantly (p < .01), and joint effusion in the affected shoulder decreased or disappeared in nine of ten patients on magnetic resonance imaging compared to their initial status.After the patients underwent interventional microadhesiolysis, the self-rated pain score or severity declined significantly (Our findings suggest that interventional microadhesiolysis is effective for managing adhesive capsulitis of the shoulder. Adhesive capsulitis of the shoulder is characterized by pain in the shoulder and limitation of glenohumeral movement. It tends to occur in patients older than 40 years of age and most commonly in females in their 50s. It has been reported that adhesive capsulitis lasts 2–3 years . Even afVarious interventions have been developed to treat this annoying condition, including oral medication, corticosteroid injection, physical therapy, nerve blocks, manipulation under anesthesia, distension arthrography, and surgical or arthroscopic release -8.Evidence exists that the pathological changes underlying adhesive capsulitis involve synovial inflammation with subsequent reactive capsular fibrosis, which is the ultimate course of adhesive capsulitis irrespective of the underlying cause . Therefointerventional microadhesiolysis, was developed to release adhesions in joints and soft tissues. The procedure has been used to relieve adhesive capsulitis of the shoulder. The objectives of this study were to introduce this procedure and evaluate the efficacy of the intervention for adhesive capsulitis of the shoulder.A nonsurgical intervention, i.e., pain in the shoulder and global loss of glenohumeral movement without underlying pathologies such as diabetes mellitus, previous upper extremity fracture, surgery with immobilisation, or stroke.Ten patients (five men and five women) with primary adhesive capsulitis of the shoulder were treated at a chronic pain management center in the Republic of Korea between 2005 and 2006. The diagnosis of primary adhesive capsulitis in the subjects was made by an expert in pain management based on the medical history and physical examination, The average age of the subjects was 56.0 ± 7.9 years: 59.0 ± 8.9 years for the males and 53.0 ± 6.3 for the females. The average pain duration in the subjects was 6.2 ± 2.9 months: 5.0 ± 1.4 months in males and 7.4 ± 3.6 months in females. The adhesive capsulitis affected the left shoulder in four patients (two men and two women) and the right shoulder in six (three men and three women). Table The needles used in interventional microadhesiolysis are shown in Figure In medicine, hollow injection needles are generally used to administer medications into tissues. They are rigid and inflexible, penetrating tissues that are softer than the needle or are stopped if the tissues are harder, which can damage the tissues. Therefore, a new type of needles was developed for interventional microadhesiolysis. They are streamlined, solid, flexible, and have blunt round tips Figure . They weInterventional microadhesiolysis for adhesive capsulitis involves three release approaches: subacromial release, posteroinferior capsule release, and subcoracoid release. The Round Needle is used for the subacromial release, the Flexed Round Needle for the posteroinferior capsule release, and Ahn's needle for the subcoracoid release.®, 2–2.5 mg/kg for induction and 100–200 μg/kg/min for maintenance) to avoid pain during the procedure.First, the patient is asked to lie on a table in the prone position and is sedated with intravenous propofol  is applied between the skin of the patient and the surgical glove. The ultrasound gel applied between the linear probe and the surgical glove does not need to be sterile, but that applied between skin of the patient and the surgical glove should be sterile.Fluoroscopy Figure  and ultrAfter completing each phase of the release, about 5 ml of diluted triamcinolone acetonide (0.4 mg/ml) is introduced along each microadhesiolysis route to prevent readhesion after the procedure Figure . The solAfter the patients undergo the initial intervention, their pain level and range of motion (ROM) are evaluated every 3 weeks. If the patient complains of persistent pain or limited ROM, the intervention is repeated 3 weeks later.We selected three outcome measures to evaluate the treatment effect of interventional microadhesiolysis in adhesive capsulitis: the self-rated pain score or severity, the glenohumeral ROM of the affected shoulder, and magnetic resonance imaging (MRI) of the affected shoulder. These measures were assessed before and after the intervention.The patients were asked to rate their overall pain level using a visual analogue scale (VAS) consisting of a 10-cm line anchored by two extremes of pain. They were also asked to rate the severity of pain at night, during rest, and on activity to evaluate the pain level in specific situations. The severity was described as 1 = none, 2 = mild, 3 = moderate, 4 = severe, or 5 = very severe pain.Glenohumeral ROM was measured with the patients in a supine position. To measure glenohumeral internal rotation, the humerus was kept in maximal allowable abduction with the elbow flexed 90° while the examiner's hand prevented the scapula from elevating or tilting anteriorly. The forearm was taken toward the supporting surface of the examining table with the palm facing toward the examining table, moving the extremity into internal rotation. Once a firm end point was felt, the ROM was measured. External rotation ROM was taken from the same starting position as for the internal rotation ROM measurement. In this measurement, the forearm was taken posteriorly so that the extensor surface of the forearm was moved toward the head of the examining table . The finThe patients were also examined with a 1.0-T MRI unit . Axial, oblique sagittal, oblique coronal T2-weighted , and proton density-oblique coronal or proton density-axial images were evaluated. We did not perform MR arthrography using intra-articular contrast injection because the patients did not want to undergo an invasive diagnostic procedure before they underwent the invasive treatment, i.e., interventional microadhesiolysis. The radiological diagnosis was based on reported MR findings in adhesive capsulitis -17: thicThickening of the IGHL and a minimal or moderate joint effusion were detected on the MRI obtained before intervention. The thickness of the joint capsule and synovium was measured on the oblique coronal T2-weighted image. The minimum thickness was 4.2 mm and the maximum was 9.1 mm . Their mean VAS pain score decreased 5.2 ± 2.0 points (range 2–8 points). The severity of pain at night decreased 3.0 ± 1.3 points (range 0–4 points), that at rest decreased 1.2 ± 0.8 points (range 0–2 points), and that on activity decreased 1.8 ± 0.6 points (range 1–3 points). Conversely, the ROM increased significantly (p < .01). The angle of abduction increased 85.5 ± 15.0° (range 60–105°), that of external rotation increased 44.5 ± 18.8° (range 15–60°), and that of internal rotation increased 33.0 ± 9.5° (range 15–45°)  was prescribed to the patients who complained of severe pain after waking.The patients underwent an average of 1.8 ± 0.6 interventions (range 1–3). Except for the pain after waking following sedation, no significant or fatal adverse effect was noted. Fentanyl 50 μg/h patch (Durogesicp < .01), the ROM of the affected shoulder increased significantly (p < .01), and the joint effusion in the affected shoulder decreased or disappeared in nine of ten patients on MRI compared to their initial status. These results suggest that interventional microadhesiolysis is effective for managing adhesive capsulitis of the shoulder.After the patients underwent interventional microadhesiolysis, the self-rated pain score or severity declined significantly  [Our technique does not include an intra-articular approach. It aims to release the structures that cause significant loss of ROM of the shoulder. It does not aim to release the entire capsule because most studies do not describe significant capsular adhesion as a predominant finding in adhesive capsulitis. Although the glenohumeral joint synovial capsule is often involved in adhesive capsulitis, most of the significant loss of ROM results from pathology in structures outside of the glenohumeral joint synovial capsule (l bursa) . The posl bursa) -17. The Follow-up MRI showed that joint effusion decreased or disappeared. The increased shoulder mobility after the intervention might have contributed to this finding. However, no significant change was noted in the thickening of the IGHL. Although the clinical condition of the patients improved, it might take more time to regenerate collagen and the follow-up period for MRI might be insufficient to detect overt changes in the thickness of the IGHL.Three patients underwent one intervention only, six patients underwent two interventions, and one patient underwent three interventions. In our clinical experience, the treatment outcomes of those who had an underlying partial rotator cuff tear or biceps tendinopathy combined with adhesive capsulitis were not favorable and they needed more than one intervention. We also postulate that the underlying shoulder instability contributed to the unfavorable outcome of the initial treatment.We recommend that all of the procedures in interventional microadhesiolysis for adhesive capsulitis of the shoulder be performed in sequence. The sequential combination of all three release procedures enables full ROM of the affected shoulder joint in all directions.Interventional microadhesiolysis has several advantages compared to other interventions for adhesive capsulitis. Although this technique is invasive, it is minimally so. A skilled operator and assistant can perform this technique in 30 min for unilateral shoulder. Pre-interventional clinical laboratory tests and imaging diagnosis can be obtained at outpatient clinics and the patient need not be hospitalized for this treatment. Operators can control the extent of adhesiolysis using the specially made needles for interventional microadhesiolysis. We believe that the characteristics of the specially made needles – streamlined shape, being solid but flexible, and having a round, blunt tip – enable the operators target the lesion accurately, reach a wide area, and allow the minute release of adhesions, while minimizing unwanted tissue damage. As in other invasive interventions, we caution that the contraindications of interventional microadhesiolysis include, for example, pregnancy, bleeding tendency, and generalized weakness.This study was a case series, which poses a limitation, although we observed favorable treatment results. Thus, further studies or randomized clinical trials are needed to evaluate the efficacy of interventional microadhesiolysis compared to other treatment methods for adhesive capsulitis of the shoulder.i.e., Round, Flexed Round, and Ahn's Needles) and three release approaches  were used in interventional microadhesiolysis. After the patients underwent interventional microadhesiolysis, selected outcome measures  were improved compared to their initial status. Thus, interventional microadhesiolysis is effective to manage adhesive capsulitis of the shoulder.Interventional microadhesiolysis was developed to release adhesions in joints and soft tissues. The procedure was used to treat 10 patients with primary adhesive capsulitis of the shoulder. Three specially made needles (The author(s) declare that they have no competing interests.KA developed the interventional microadhesiolysis technique and the three specially made needles used in this study. KA and YJL designed the study. EHK collected the data. SMK and TKL were the assistants during the procedure and they also assisted with data collection and processing. YSK interpreted the magnetic resonance findings of the patients. HJJ analysed the data and wrote the manuscript.The pre-publication history for this paper can be accessed here:


Gynecological laparoscopy is a commonly performed procedure. Providing anesthesia for this can present a challenge, particularly in the day surgery population. Poor analgesia, nausea, and vomiting can cause distress to the patient and increased cost for the health system, because of overnight admission. In this review we discuss anesthetic and analgesic techniques for day-case gynecological laparoscopy. The principles include multimodal analgesia, the use of the oral route wherever possible, and the contribution of the surgeon. Laparoscopy was first performed about a century ago, but came into more routine practice around 50 years ago. This wasThis review will focus on day-case laparoscopy. It is essential that the analgesia provided is sufficient for the patient to mobilize by the evening of surgery and control the pain which may persist for several days after the operation. The pattern of pain may change over this period, with pain in different sites becoming more or less prominent. AnalgesiLocal pain will be associated with incisions for the operative ports. Lower abdominal pain may depend on the extent of intraperitoneal manipulation during diagnostic laparoscopy. Sterilization operations cause ischemia or damage to the fallopian tubes and are generally more painful than simple diagnostic procedures, with clips generally causing less pain than other techniques to occlude the tubes.et al. found that the worst pain after gynecological laparoscopic surgery was felt in the shoulder in 1% of the patients, two hours after surgery, but in 70% of the patients 24 hours after surgery.[et al. found that the pain attributed to intraperitoneal gas was as frequent as abdominal wall pain at 24 hours, but declined markedly by 48 hours, along with a corresponding reduction in the retained gas shown on X-ray.[Upper abdominal, shoulder tip, and postural high back pain after laparoscopy are likely to be caused by gas retained in the peritoneal cavity. Carbon dioxide is usually used to expand the abdomen to allow surgical visualization. Although it is a soluble gas in comparison to oxygen and nitrogen, it can take up to two days to be absorbed from the peritoneal cavity. Pain from the residual gas is of delayed onset and may present once the patient has gone home. Hohlrieder on X-ray.There are many trials of individual drugs versus placebo, but relatively few direct comparisons between drugs. A systematic review has allowed the production of comparative Tables of analgesic strength. The resuProviding analgesia before the surgical stimulus should, according to theoretical principles, reduce the amount of pain felt after surgery compared to cases where analgesia has been given after the surgical stimulus. In clinical practice this has at best only a minor effect. However,The oral route is acceptable for day-case surgery as the gastrointestinal function is generally not significantly affected (unless there is postoperative nausea and vomiting (PONV)). Tablets may be used for premedication as well as postoperatively once the patient can tolerate drinking. Starvation guidelines are often more stringently applied than necessary because of the difficulty in coordinating the last intake and the start of anesthesia. Although this is defensible in the case of food, because of the consequences of pulmonary aspiration of undigested food, it is less rational for fluid intake. Water, isotonic drinks, and clear fruit juice are cleared from the stomach within two hours.Suppositories are often given during general anesthesia, in which case it is sensible to do this before surgery rather than at the end to allow time for drug absorption and distribution. Drugs that have to be given intramuscularly such as prochlorperazine should preferably be given during general anesthesia, for patient comfort.Patients will often have an intravenous cannula in place for several hours after surgery, and therefore the intravenous route is also an option after surgery, especially in the presence of PONV.3 receptor antagonists. Although the mechanism of paracetamol analgesia is complex and not yet fully elucidated, part of its effect is mediated via a central serotonergic mechanism,[3 receptor antagonists such as granisetron.[in vivo; 5-HT3 receptor antagonists do not directly antagonize paracetamol in vitro, and thus an indirect mechanism has been postulated.Paracetamol is on the bottom step of the World Health Organization's pain ladder. It is useful for mild-to-moderate pain and has a morphine-sparing effect of up to 20% when used for more severe pain.8 It does9echanism, which manisetron. This hasThere is no absorption of paracetamol from the stomach, but there is a rapid uptake from the duodenum and small intestine. The optimum administration will therefore be when the stomach is empty. Peak plasma concentrations occur about 10 to 60 minutes after oral administration. It has been found to have a more variable onset when administered after minor surgery, possibly because of delayed gastric emptying after surgical stress. The use Paracetamol may also be given as an intravenous dose of 1 g. This is well-tolerated and produces rapid peak plasma levels. The only disadvantage is the price, which is approximately 150 times the cost of tablets. However, intravenous paracetamol is convenient to use at induction of anesthesia if paracetamol premedication has been omitted.NSAIDs alone or in combination with paracetamol are unlikely to provide adequate analgesia in the early postoperative period by themselves, but may reduce the need for opioids. Although2 antagonists, proton pump inhibitors or misoprostol), and slow-release formulations. However, it should be noted that these drugs have their own side effects (particularly the -coxib group of drugs and thrombotic events).There are a significant minority of patients in whom NSAIDs are relatively or absolutely contraindicated. Some anesthetists give them to patients with gastric sensitivity and asthma, but this should be as a result of a risk-benefit analysis and after discussion with the patient. Gastric side effects are not completely avoided by parenteral or rectal administration, and options that may be considered include the use of COX-2 selective NSAIDs (-oxicams or -coxibs), gastroprotective drugs  and the pharmacokinetics  of opioids. A mutatiOther drugs, outside the traditional analgesics have been trialed for postoperative analgesia. In a recent study from Finland, the γ-amKetamine given preoperatively demonstrates an analgesic benefit over that given postoperatively. However,et al. performed a systematic review of local anesthetic techniques for laparoscopy.[Moiniche aroscopy. They fouaroscopy. Other tearoscopy.  and about 1% of day surgical patients will be admitted overnight because of it.et al. demonstrated that the risk factors for PONV are the female sex, non-smoking, history of PONV or motion sickness, and postoperative morphine.[et al. also found a dose-dependent effect of volatile anesthesia.[Apfel morphine. The firsesthesia.et al. showed that PONV could be reduced by multimodal prophylaxis, including total intravenous anesthesia and three antiemetic agents.[et al. showed that increasing the intraoperative fluid prescription from 10 ml/kg to 30 ml/ kg, for gynecological laparoscopy, reduced the cumulative incidence of PONV over the 72-hour perioperative period from 27 to 6%.[The cost-effectiveness of prophylactic anti-emetics for all patients has been debated, especially for more expensive drugs. Scuderi c agents. However,27 to 6%.Low-dose propofol infusion has previously been used for rescue anti-emesis. However, a recent study in patients undergoing gynecological laparoscopy found that bolus doses of propofol 0.5 mg/kg administered at the end of surgery were effective in reducing PONV, when compared to placebo. Lower doet al. may allow a sensible compromise between ‘blanket’ treatment and no prophylaxis. It is probable that these interventions apply only to early PONV. Different factors apply to the occurrence of PONV beyond 24 hours.Targeting individual patients with the risk stratification of Apfel et al. found that early pain, nausea, and 24-hour morphine consumption using patient-controlled analgesia was less in women who had their airway managed with a Proseal laryngeal mask airway (PLMA) compared to tracheal intubation.[4Hohlrieder ubation.4 Their exubation.442 The PLThe European Society of Regional Anesthesia and Pain Therapy produce evidence-based guidelines on the anesthetic technique for specific procedures. However,For the immediate control of severe pain on waking after general anesthesia, intravenous opioids should be titrated to effect. Both fentanyl and morphine can be used. Morphine leads to a reduction of about three-and-a-half times the amount of supplementary oral analgesia used, compared to fentanyl, but causes about twice as much nausea and vomiting.We prescribe intramuscular morphine as escape analgesia for the step-down ward. The aim is to give this rarely, which will be true if the patients have had sufficient attention paid to analgesia at the earlier stages of the procedure. Other postoperative analgesia prescriptions are paracetamol, codeine, and diclofenac.A combination of paracetamol 1 g/codeine 60 mg four times a day, as well as an NSAID (for example diclofenac or ibuprofen) should be prescribed for five days. It shoulThere are a vast number of possible permutations to a routine analgesic and antiemetic regimen, as well as one tailored for patients with specific problems. Furthermore, drug availability and social, genetic and racial differences are further confounding factors. The key principles are to have a multimodal regimen, regular pain scoring, and encouraging patients to ask for analgesia. Patients' recovery to full function is enhanced by good quality postoperative analgesia.


Pain is common in head and neck cancer (HNC) patients and may be attributed to the malignancy and/or cancer treatment. Pain mechanisms and patient report of pain in HNC are expected to include both nociceptive and neuropathic components. The purpose of this study was to assess the trajectory of orofacial and other pain during and following treatment, using patient reports of neuropathic pain and nociceptive pain and pain impact.124 consecutive HNC patients receiving radiation therapy (RT)  participated in a patient-reported outcome (PRO) assessment. Patients completed the McGill Pain Questionnaire three times during therapy and 3 months following study entry.The majority of patients related their pain to the tumor and/or cancer treatment. Whereas 59% reported their pain to be less severe than they expected, 29% were not satisfied with their level of pain despite pain management during cancer therapy. Worst pain was 3.0 ± 1.3 on a 0- to 5-point verbal descriptor scale. Pain intensity was present at entry, highest at 2-week follow-up, declining towards the end of treatment and persisting at 3-month follow-up. The most common neuropathic pain descriptors chosen were aching (20%) and burning (27%); nociceptive words chosen were dull (22%), sore (32%), tender (35%), and throbbing (23%), and affective/evaluative descriptors were tiring (25%) and annoying (41%). 57% of patients reported continuous pain, and combined continuous and intermittent pain was reported by 79% of patients.This study provides evidence that patients with HNC experience nociceptive and neuropathic pain during RT despite ongoing pain management. The affective and evaluative descriptors chosen for head and neck pain indicate considerable impact on quality of life even with low to moderate levels of pain intensity. These findings suggest that clinicians should consider contemporary management for both nociceptive and neuropathic pain in head and neck cancer patients. Pain is common for the 35,310 people who are diagnosed with head and neck cancer (HNC) in the United States annually . HNC paiNeuropathic pain is defined by The International Association for the Study of Pain (IASP) as pain initiated or caused by a primary lesion or dysfunction in the nervous system resulting in debilitating pain . Damage One of the most feared consequences of cancer is the possibility of severe and uncontrolled pain in patients with advanced cancer . In patiCancer pain causes increased morbidity, reduced performance status, increased anxiety and depression, and diminished quality of life (QOL) ,26-28. HPain may be the first symptom in 20% to 50% of all cancer patients  due to tIn HNC patients, neuropathic pain has not been well characterized in terms of sensory report  or sensory quantification . Grond et al.  reportedWe conducted a 3-month repeated-measures study to describe the trajectory of pain and pain descriptors in consecutive patients with HNC. The study was approved by the Institutional Review Board at the University of Washington for initial data collection and at the University of Illinois at Chicago for ongoing data analysis.Eligible subjects: (a) had a diagnosis of HNC; (b) spoke and read English; and (c) had pain related to the cancer or to cancer therapy during the week prior to enrolling. Patients were excluded if they: (a) had surgery within one month; (b) were physically unable to complete study procedures; or (c) were mentally unable to complete study questionnaires because of brain metastases or developmental problems, as measured by a Mini-Mental State Exam (MMSE)   and exported it to SPSS  for data analysis. We present descriptive statistics for the pain location, intensity, quality, and pattern, as well as the number of nociceptive and neuropathic descriptors reported at each measurement time point. Pain quality findings are reported for the first pain site reported that was located in the head and neck region. We plotted scores and calculated repeated-measures ANOVAs over time for pain scores reported during the 3-month study.Patient characteristics are shown in Table Prior to study entry, the majority of patients reported pain for 0–6 months (77%), 7–12 months (5.6%), 13–23 months 4%), or more than 2 years (12.9%). At baseline, patients associated their pain with their cancer (21%), surgery (53.2%), or both tumor and surgery (20.5%). On average, patients reported 2.1 ± 2.2 pain sites. Pain measures at baseline are shown in Table %, or morThe pain intensity scores presented in Table F = 48.5, p < 0.001); the number of the nociceptive words chosen  = 51.2, p < 0.001)  = 11.9, p < 0.001); PRI-A  = 1.5, p < 0.21); PRI-E  = 3.5, p < 0.02); PRI-M  = 2.6, p < 0.05); PRI-T  = 9.2, p < 0.001)  = 8.7, p < 0.001).Pain scores decreased from admission to last follow-up. ANOVA showed significant decreases in the pain measures over the 4 time points: the number of the neuropathic words chosen . At time 3, worst pain was 2.89 ± 1.23, and at time 4 worst pain was 2.54 ± 1.40, current pain 1.02 ± 1.07 and least pain 0.60 ± 0.81 , 21% adjuvant analgesics, 8.1% step 2 opioids (for mild to moderate pain intensity), 20.2% step 3 opioids (for moderate to severe pain intensity). The other patients were taking combinations of analgesics and adjuvant drugs: 8.9% adjuvant and step 1 analgesics; 3.2% adjuvant and step 2 opioids; 4% adjuvant and step 3 opioids; 6.5% step 1 and step 2 opioids; 1.6% step 2 and step 3 opioids; 1.6% adjuvant, step 1, and step 2 opioids; 0.8% adjuvant, step 1 and step 3 opioids; and 11% were missing analgesic drug data.We estimated adequacy of analgesic prescription by calculating a pain management index (PMI) as suggested by Cleeland ,56. We sHNC patients were enrolled in the study during cancer treatment when pain was reported. Patients attributed their pain to the cancer, prior surgical treatment or the ongoing radiation therapy for HNC. Pain was discomforting on average at entry (worst pain intensity 3.0 ± 1.3), and it was less than anticipated in more than half of the patients, as expected in about one-fifth and worse than expected by some. In our survey, pain was reported first in the head and neck or oral cavity by 79% (n = 98) of the participants.In a previous study, pain was reported by patients with oral squamous cell carcinoma at presentation in 39% of 138 cases and correlated with tumor stage . Pain atNeuropathies are commonly reported in patients with malignancy (1.7%–5.5%) and may be due to direct effects of the tumor, paraneoplastic syndromes and/or treatment-related toxicity -64. NeurThe most common acute oral side effect of chemotherapy and radiotherapy is oral mucositis . Oral muSurgical procedures commonly result in acute nociceptive orofacial pain and establish conditions that may lead to painful post-surgical neuropathy. In addition to tissue injury at tumor resection, morbidity is increased by concomitant procedures such as radical neck dissection . In thisThe affective and evaluative descriptors chosen for head and neck pain indicate considerable impact on quality of life, even with low to moderate levels of pain intensity. Effective management requires accurate diagnosis of the multifaceted etiology of orofacial pain in cancer patients ,86. PainNociceptive pain is managed with treatment of the cause and topical anesthetics and analgesics, with reliance upon systemic analgesics. Neuropathic pain is typically more difficult to manage and in contrast relies upon locally acting anesthetics and centrally acting antidepressant and anti-convulsant medications, along with biopsychosocial treatment and systemic analgesics. Future research regarding pain in head and neck cancer patients should consider neuropathic and nociceptive pain-related complaints along with quantitative sensory testing to confirm neuropathic pain. In clinical practice, clinicians should consider contemporary management for both nociceptive and neuropathic pain in head and neck cancer patients.Pain experienced during radiation therapy for head and neck cancer is common. Neuropathic pain descriptors were chosen by 73% of patients and a linear trend was seen in number of neuropathic and nocicpetive descriptors chosen by pateints during therapy. Pain was common despite ongoing pain management during therapy. This study shows that pain during radiation therapy have both nocicpetive and neeuropathic qualities.The authors declare that they have no competing interests.JE reviewed study data and drafted the manuscript. YOK performed the statistical analysis. DJW conceived of the study, and participated in its design and coordination and helped to draft the manuscript. All authors contributed to and approved the final manuscript.


Low back pain (LBP) has become a main cause of absenteeism and disability in industrialized societies. Chronic LBP is an important health issue in modern countries. Discogenic LBP is one of the causes of chronic low back pain. The management of chronic discogenic LBP has been limited to either conservative treatment or operative treatment. Intradiscal electrothermal therapy (IDET) is now being performed as an alternative treatment.Ninety-three consecutive patients undergoing IDET at 134 disc levels from October 2004 to January 2007 were prospectively evaluated. All patients had discogenic disease with chronic LBP, as determined by clinical features, physical examination and image studies, and had failed to improve with conservative treatment for at least 6 months. Follow-up period was from 1 week to 3 or more years postoperatively.There were 50 male and 43 female patients, with a mean age of 46.07 years . The results were classified as symptom free (100% improvement), better (≥50% improvement), slightly better (<50% improvement), unchanged and aggravated. Eighty-nine patients were followed up in the first week; of them, 77 (86.52%) patients had improvement . The improvement rate gradually decreased to 80.90% in 1 year; and 73.91%, in 3 years.In conclusion, IDET offers a safe, minimally invasive therapy option for carefully selected patients with chronic discogenic LBP who have not responded to conservative treatment. Although IDET appears to provide intermediate-term relief of pain, further studies with long-term follow-up are necessary. The purpose of this study was to evaluate IDET's role as a definitive treatment for chronic discogenic low back pain in strictly selected patients. We hypothesized that IDET would be a beneficial additional treatment option for chronic discogenic low back pain. Here we present a single-arm, prospective analysis on 93 patients who had severe low back pain with or without radicular pain. They all were treated with application of IDET, and we evaluated the efficacy of IDET and the ability of patients to manage day-to-day tasks of life after IDET treatment.The IDET was performed as an outpatient procedure from October 2004 to January 2007 according to the inclusion and exclusion criteria listed in negative control discannular penetration of the dyesingle painful discs onlypositive pain behavioral signs during injection .The degree of pain was recorded by visual analog pain scale. Oswestry low back pain disability questionnaire has been designed to give information as to how back pain has affected ability to manage everyday tasks of life. So we used Oswestry low back pain disability questionnaire to evaluate the ability to manage everyday tasks of life.The IDET procedure uses a navigable intradiscal catheter with a thermal resistive coil. The procedure was performed under local anesthesia with lidocaine. Using fluorography, a 30-cm spineCATH catheter  with a 5-cm active electrothermal tip was inserted anteriorly into the annulus or nucleus via a 17-gauge introducer. The active tip was advanced anterior-laterally inside the nuclear tissue and directed circuitously to return posteriorly, providing an ideal position to heat the entire posterior annulus. Once a satisfactory position was obtained in the anteroposterior, lateral views, the catheter was connected to a lead and passed to an independent technician. In all cases, the catheter tips were within 5 mm of the posterior vertebral margin upon review of saved fluoroscopic films. We used a standard protocol in which heating began at 65°C and was increased incrementally by 1°C every 30 seconds to achieve a final temperature of 90°C. The final temperature was maintained for 4 minutes, giving a total treatment time of 16.5 minutes.The demographic and clinical features of the patients are listed in The results were classified as symptom free (100% improvement), better (≥50% improvement), slightly better (<50% improvement), unchanged and aggravated. The results of low back pain after IDET are listed in The results with regard to post-IDET lower limb pain are listed in A significant improvement in physical functioning was demonstrated by the IDET-treated group as measured by the physical functioning scale of the Oswestry low back pain disability questionnaire. A significant improvement was detected at 6 months post-treatment. The average of Oswestry scale scores of the 89 patients pre-IDET was 31.72, which decreased to 16.66 after 1 year of IDET treatment. There was 47.48% improvement from pre-IDET to 1 year post-IDET .0. Thus, IDET treatments showed significant beneficial effects.The data were analyzed by using paired t tests to evaluate the therapeutic effects of IDET treatments. We constructed a 99% (α= 0.01) confidence interval, and we found it would reject null hypotheses HIntradiscal electrothermal heating treatment is a minimally invasive procedure used to treat patients with low back and referred leg pain, but how or why heating decreases discogenic pain is unclear.10 There 9999et al. recently published a review paper about evidence-informed management of chronic low back pain with intradiscal electrothermal therapy.[et al. recently published a meta-analysis [et al. compared validated outcome measurements of 18 IDET studies with the same outcome measurements reported by 33 studies of fusion for degenerative disc disease.[et al. but reached different conclusions.[Derby  therapy. They madanalysis  of 17 ID disease. A meta-aclusions. Their reIn our paper, we have described treatment of 93 cases with 134 degenerated disc levels by applications of IDET procedure and tried to analyze the results. The single-arm, prospective analysis showed that the application of IDET is a safe and useful intervention for chronic low back pain. The satisfactory pain relief obtained in the majority (more than 50%) of our patients only with chronic low back pain and lower limb pain justifies a study of at least 2 years. Approximately more than half of the patients were satisfied with their outcomes, and nearly all continued to follow up approximately 2 years post-IDET in this study cohort. These results are a great contrast to those of the previous studies evaluating outcomes of the IDET procedure.Although the initial research appeared promising, IDET should be scrutinized more closely using controlled studies. On more long-term follow-up of this patient population, we find that this procedure may be less effective than previously reported. Only through the use of a blinded, treatment-uncontrolled study with long-term follow-up can questions regarding the efficacy of IDET be fully answered.


Objective To assess the quality of telephone triage by following the consecutive phases of its care process and the quality of the clinical questions asked about the patient’s clinical condition, of the triage outcome, of the content of the home management advice, and of the safety net advice given at out of hours centres.Design Cross sectional national study using telephone incognito standardised patients. Setting The Netherlands.Participants 17 out of hours centres.Main outcome measures Percentages of clinical obligatory questions asked and items within home management and safety net advice, both in relation to pre-agreed standards, and of care advice given in relation to the required care advice.Results The telephone incognito standardised patients presented seven clinical cases three times each over a period of 12 months, making a total of 357 calls. The mean percentage of obligatory questions asked compared with the standard was 21%. Answers to questions about the clinical condition were not always correctly evaluated from a clinical viewpoint, either by triagists or by general practitioners. The quality of information on home management and safety net advice varied, but it was consistently poor for all cases and for all out of hours centres. Triagists achieved the appropriate triage outcome in 58% of calls.Conclusion In determining the outcome of the care process, triagists often reached a conclusion after asking a minimal number of questions. By analysing the quality of different phases within the process of telephone triage, evaluation of whether an appropriate triage outcome has been arrived at by means of good clinical reasoning or by an educated guess is possible. In terms of enhancing the overall clinical safety of telephone triage, apart from obtaining an appropriate clinical history, adequate home management and safety net advice must also be given. Telephone triage can be described as the care process by which the degree of urgency of a patient’s clinical problem presented by telephone and the care needed are determined.3The safety of the advice given by triagists is often questioned,15We could not identify any studies that investigated the safety of telephone triage by assessing the quality of each phase of the process of telephone triage. Therefore, the objective of this study was to make a global assessment of quality, specifically the quality of the clinical questions asked, the evaluation of the answers, the triage outcomes, and the content of the home management and safety net advice, in telephone consultations carried out by triagists at out of hours centres in the Netherlands.To assess the quality of clinical case handling at out of hours centres, telephone incognito standardised patients presented seven different clinical cases three times each to 17 different out of hours centres over a period of 12 months, totalling 357 calls.We applied several criteria for the selection of cases. The cases were to be based on symptoms that are known to present frequently on the telephone to out of hours centres,The box shows the obligatory questions for each case. Table 1Can you describe the child’s behaviour now?How high is the temperature of the child?Has the child had a fit?Does the child have pain anywhere?Has the child got, or has he or she had, a headache?Can the child touch forehead on knees (or kiss knees)?Does the child seem breathless or is there indrawing of the chest/tummy?How much fluid has been taken in the past 12 hours?When did the child last pass urine?Does the child have a rash?Did the child recently travel abroad?Duration of nosebleed?How many nosebleeds have you had in the past 48 hours?How much blood has been lost?Have you vomited any blood?Has there been a blow to the head?Are you feeling faint?Might you have a foreign object in the nose?Do you have bruises anywhere?Do you have a bleeding disorder?Do you take anticoagulant (blood thinning) treatment?Did the fever start with shaking/rigor?How high is the temperature?Do you have a stiff neck?Do you have any difficulties with breathing?Is there any pain when passing urine?How much fluid has been taken in the past 12 hours?When did you last pass urine?Any major long term health problem?Did you recently travel abroad?Can you describe the child’s behaviour now?How often did the child vomit in the past six hours?How much did the child vomit?Did the child vomit blood?Did the child drink in the past six hours?When did the child pass urine the last time?Did the child complain about pain when passing urine?Does the child have a rash anywhere?Does the child have fever?Does the child complain about a headache?Can the child touch forehead on knees (or kiss knees)?Does the child complain about abdominal pain?Does the child complain about photophobia?Did the child have a head injury recently?Did the child eat the wrong food?To use up to date protocols, we decided to revise existing national protocols as these were four years old.21To reach consensus and achieve standardisation for this study we presented these protocols to a panel of general practitioners with experience in telephone triage at out of hours centres. They agreed on the obligatory questions that should be asked about the different clinical symptoms and what should be discussed with the patient in relation to home management and safety net advice.Lay people have been used as “unannounced” or “incognito” standardised patients for many years to assess the performance of students and healthcare professionals during face to face and telephone consultations. Evidence shows that this method is a reliable and valid instrument to assess clinical performance.25Specially trained telephone incognito standardised patients presented the cases. They received a scenario with information on their personal data, the clinical problem, their personal situation (such as feeling anxious), and the answers to be given to the obligatory questions if they were asked. If they were invited to come for a consultation at the out of hours centre, they were instructed to ask for the reason for this request. Another panel of general practitioners validated the scenarios and considered them realistic and representative of cases that might present to out of hours centres. No additional obligatory questions were needed to determine clinical urgency. They agreed that it was reasonable for telephone incognito standardised patients to receive self care advice for cases 1, 2, 4, and 6 and to be advised to be seen the same evening for cases 3, 5, and 7.To increase the chances of speaking to different triagists, the telephone incognito standardised patients called in the evening between 7 pm and 9 pm on different days of the week. They made the calls from their private home, pretending to be in the area of the involved out of hours centre. They audio recorded the calls for further assessment.In October 2004 105 out of hours centres were operative in the Netherlands. In 2005 they received a total number of 3.3 million calls. Of these, 38% resulted in self care advice .We asked all centres for permission to be selected for the research study. Of the 98 centres that gave permission, we selected 17 out of hours centres but did not inform them of this. We did a balanced selection, whereby for each of the 12 provinces of the Netherlands the size of the population in that province determined the number of out of hours centres to be selected. We then selected centres at random. After the study we asked the 17 out of hours centres by letter whether they had detected a telephone incognito standardised patient during the previous 12 months.The required frequency of presentation of the cases developed was based on generalisability theory.We made a transcript of every recorded call and assigned each call to two medical students as raters. They scored calls independently by using the standard protocol as a checklist. They rated each item by marking “Yes” (=1: question is asked/advice is given) or “No” (=0: question is not asked/advice is not given).For each call, we recorded the following variables as indicators of quality: percentage of obligatory questions asked in relation to the agreed standard set of questions; percentage of items within home management and safety net advice in relation to the agreed standard set of items; percentage of obligatory questions asked in relation to all questions asked; percentage of appropriate care advice given in relation to the required care advice. For each of these variables we used the average percentage of the two raters for further analysis of each case for all out of hours centres and for each out of hours centre for all cases. We used the statistical software package SPSS version 15 for descriptive statistics and analysis of variance.Tables 3The overall mean percentage of obligatory questions asked was equal to 21% of the standard. The mean percentage varied between 15% at out of hours centre number 6 and 42% at number 5, but at all centres the percentage was consistently far below the standard (100%). We found a similar pattern between cases: some variation between cases existed, but for all cases the mean percentage was far below the standard.The overall mean for the content of home management and safety net advice was 40%  in which the “patient” mentioned the use of Malarone. The outcome of these return calls was self care advice on four occasions, and on two occasions the telephone incognito standardised patient was advised to be seen the same evening for further assessment .The results of this study identify shortcomings and educational needs in telephone triage, indicated by assessing the quality of phase one  and phase two (giving care advice) of the process of telephone triage. The mean score for obligatory questions asked was 21% of the agreed standard. Answers to obligatory questions were not always evaluated clinically correctly. The quality of the information given on home management and safety net advice was also consistently below the standard. The appropriate triage outcome was reached in only 58% of calls.Triagists are known to respond very accurately to cases of high urgency but not to moderate and low urgency cases such as those presented in this study.As none of the 17 out of hours centres had detected any of the telephone incognito standardised patients and different triagists handled 97% of all calls, we conclude that this study reflects the day to day performance of call handling at those centres.Some members of the scenario panel considered case 2 (adult with nosebleed) as likely to be a frequently presented case but case 3 (as case 2 but with bruises) as quite uncommon. We decided to present this case, as it is an example of an uncommon but potentially life threatening symptom,In our study many obligatory questions remained unasked, and triagists often asked questions that the protocol and scenario panels did not consider as required to determine an urgency level. This means that for telephone triage, history taking was often not carried out effectively. For instance, for the case of nosebleed triagists often asked the question: “Do you have an allergy or hypertension?” This shows that the triagist investigated a possible cause of nosebleed, which is not relevant for determining the degree of its urgency, whereas questions about bruises or the amount of blood loss were not asked.Research shows that triagists often ask few questions and do not use or follow protocols.Triagists at out of hours centre number 5 asked significantly more obligatory questions for all cases than did those at any other centre. However, this did not result in a higher number of appropriate outcomes than at the other centres. Determining the reason for this would need further investigation.An example of misinterpretation of an answer took place on a Friday evening when the triagist of an out of hours centre said to the telephone incognito standardised patient with nosebleed (case 3): “You’d better see your doctor next week because you said you have a bleeding nose and several bruises, so there might be something wrong with your blood.” Our findings on (mis)interpretation of answers by triagists and general practitioners confirm that in addition to asking the right questions, understanding the relevance of the answers is equally important.Triagists gave a small amount of home management and safety net advice relevant to the nature of the clinical problem presented. Further research is needed to investigate whether triagists are aware of the importance of this advice, especially if self care advice is given.Triagists seemed to carry out a rapid clinical scan before they came to a conclusion, without considering in sufficient detail different causes for a symptom or its possible consequences. Even when the triagist gave the required self care advice, for nearly all calls this choice could be considered to be the correct choice only by means of an educated guess as so few obligatory questions were asked. This study also shows that triagists should ideally recommend a low urgency level of care only after thorough history taking. The quality of information on home management and safety net advice varied to a large extent and was consistently low for each case and each out of hours centre.Telephone triage should aim at minimising risks to a patient’s health. The safety of telephone triage might be enhanced by using computer based decision support systems.Research on the quality of telephone triage is often focused on the quality of the outcomesLittle is known about the quality of the different phases of the care process of telephone triage by triagistsCare advice was given after asking (too) few obligatory questionsAnswers to those questions, if asked, were not always interpreted correctly by the triagist or general practitionerThe quality of home management and safety net advice was low


The causes of chronic low back pain (CLBP) remain obscure and effective treatment of symptoms remains elusive. A mechanism of relieving chronic pain based on the consequences of conflicting unpleasant sensory inputs to the central nervous system has been hypothesised. As a result a device was generated to deliver sensory discrimination training (FairMed), and this randomised controlled trial compared therapeutic effects with a comparable treatment modality, TENS.60 patients with CLBP were recruited from physiotherapy referrals to a single-blinded, randomised controlled, non-inferiority trial. They were randomised to receive either FairMed or TENS and asked to use the allocated device for 30 minutes, twice a day, for 3 weeks. The primary outcome variable measured at 0 and 3 weeks was pain intensity measured using a visual analogue scale averaged over 7 days. Secondary outcome measures were Oswestry Disability Index, 3 timed physical tests, 4 questionnaires assessing different aspects of emotional coping and a global measure of patient rating of change. Data were analysed for the difference in change of scores between groups using one-way ANOVA.Baseline characteristics of the two groups were comparable. The primary outcome, change in pain intensity (VAS) at 3 weeks showed a mean difference between groups of -0.1, (non significant p = 0.82). The mean difference in change in ODI scores was 0.4; (non significant p = 0.85). Differences in change of physical functioning showed that no significant difference in change of scores for any of these test (p = 0.58 – 0.90). Changes in scores of aspects of emotional coping also demonstrated no significant difference in change scores between the groups (p = 0.14 – 0.94).FairMed was not inferior to TENS treatment.The findings have implications for further research on current chronic pain theories and treatments. Further work to explore these mechanisms is important to expand our understanding of chronic pain and the role of neuro-modulation.UKCRN Study ID 3321 Chronic low back pain (CLBP) is a very common symptom, and a major source of distress. The causes of back pain remain obscure and effective treatment of symptoms remains elusive. Most treatments are empirical, and few have withstood close scrutiny for effectiveness .One approach is to understand the underlying causes, so that we can develop rational treatments. Current hypotheses of the basis of back pain can be broadly viewed as:1. Biomedical or "Cartesian" models, where a pain sources or sources stimulate a pain pathway to the brain.2. A bio psychosocial model.This study arose because the senior investigator (JF) has become increasingly dissatisfied with Cartesian explanations for back pain, particularly following the MRC Spine Stabilisation Trial  where siHarris  proposedDevice treatment for pain has some obvious advantages over pharmaceutical treatments, particularly that nothing has to be ingested and the side effect profile is likely to be much less. It is also likely to be cheaper than pharmaceutical management and can be used in conjunction with those rehabilitation treatments for which there is evidence of efficacy. Device treatment is likely to have a potent placebo effect. There are many devices that purport to treat back pain. The current "market leader" is transcutaneous electrical nerve stimulation (TENS), estimated to be 1% of the analgesic market for back pain The treatment effect of TENS is attributed to influencing the "gate" proposed by Melzack and Wall in their Gate Control Theory of Pain . TENS haThe aim of this study was to compare a novel sensory discriminatory training device (FairMed) with TENS in a Phase I clinical trial.The trial design was a single-blinded, longitudinal randomised controlled, non-inferiority trial.Ethical approval was given by the Milton Keynes Local Research Ethics Committee (05/Q1603/34) and all patients were approached and gave informed consent to participate in the study.A power calculation for a non-inferiority trial was made . The nonPatients referred to a Physiotherapy Department with a diagnosis of chronic low back pain were recruited to the study.Inclusion criteria were patients aged over 18 years with a diagnosis of chronic low back pain lasting a minimum of 3 months.Exclusion criteria were patients with leg pain, those who were current TENS users or patients where either of the treatment modalities might harm them. This was based on the warnings and precautions for the use of TENS namely, patients with pacemakers, damaged or broken skin, malignancy, poorly enervated areas and spinal infection.Randomisation was performed using a random numbers table. Randomisation was restricted to permuted blocks to ensure equal numbers being allocated to each group. Four blocks of patient assignment were used; two blocks of 0–9 and two of 0–19. Each random permuted block was transferred to a sequence of consecutively numbered, sealed, opaque envelopes and these were stored in a locked drawer until required. As each participant formally entered the trial, the researcher opened the next envelope in the sequence in the presence of the patient.We attempted to ensure integrity of blind assessment by maintaining separation between the therapists providing the treatment and those assessing We followed practical tips to try and reduce 'unblinding' accepted within the field , such as2 TPN 40 each) were placed in or adjacent to the painful area at a distance of 5 cm–20 cm apart. The intensity of TENS was adjusted to produce a tingling sensation that was approximately 2–3 times the sensory threshold.Patients were randomly allocated to use either TENS or the FairMed device. For the TENS group a dual channel portable TENS TPN 200 PLUS unit was used. Stimulation was based upon best available evidence from the literature. For conventional TENS, parameters between 80–100 Hz and 100–200 μs are considered to be effective in the treatment of chronic pain ,9,13. InThe FairMed group received the device Figure  which inThe outcome measures used in this trial were collected in accordance with recommendations from the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials [IMMPACT]. These 6 core outcome domains are i) pain, ii) physical functioning, iii) emotional functioning, iv) participant ratings of improvement and satisfaction with treatment, v) symptoms and adverse events, and vi) participant disposition .Pain was recorded using a 100 mm VAS recording patient's present pain intensity level, their average and worst pain intensity levels recorded over a week and averaged .Physical functioning was recorded using the Oswestry Disability Index v 2.1 . FunctioEmotional functioning was assessed using a battery of questionnaires, the Health Anxiety and Depression Scale used to assess emotional functioning ; the TamA global rating of patient reported improvement and satisfaction, the Patient Global Impression of Change scale , was assParticipants completed outcome questionnaires at baseline, 3 weeks, 6 weeks and 12 weeks. They underwent functional testing at baseline and 3 weeks with a masked assessor. Over the 3 weeks that participants used their devices, they were asked to keep a daily pain diary.Patients were explicitly asked about any adverse events they experienced using the devices, and to record these in their pain diary and by telephone report. An adverse event is considered any unwanted effect detected in participants of a clinical trial regardless of whether the effect can be attributed to the intervention under evaluation .Finally, information on participant disposition was collected to document the recruitment of participants and their progression through the trial, numbers receiving intended treatment, those completing the study protocol and analysed for the primary outcome ,24.Data were analysed using intention-to-treat analysis and the statistical package SPSS 12.0.1 for Windows.Non-parametric statistics were used to compare outcome measures between groups (One way ANOVA). Statistical significance was set at the p < 0.05 level.60 patients were randomised and recruited to the trial, 32 into the FairMed group and 28 into the TENS Group, 27 in each group completed the trial. Reasons for dropping out varied: one participant was admitted to hospital for spinal decompression surgery during his trial period, one participant withdrew citing personal circumstances, and four participants decided that they were unable to comply with the protocol after they had begun on the trial. None of the dropouts completed any re-assessments and so could not be used in further analysis.Other than the 6 participants who withdrew before completion of the trial, there was no further loss to follow up. A CONSORT flow diagram is shown in figure The mean age of participants was 53.4 years SD 11.5). Both TENS and FairMed groups comprised equal percentages of men (50%) and women (50%). Analysis of all baseline characteristics demonstrated no significant difference between groups .No significant difference in change of scores of TSK, PSE, PCS and HAD were detected for any of these outcome measures.There were no significant differences in change of scores for physical functioning using the 1 minute sit to stand, 1 minute stair and 5 minute walk test scores at baseline and at 3 weeks.In the FairMed group, 27% of participants stated that they were more able to cope with pain at 3 weeks; in the TENS group, this number was to 45%. However, 11% of TENS group participants also stated that they were less able to cope with pain at 3 weeks. 73% of FairMed group participants stated no change in their ability to cope with pain, compared to 44% in the TENS group.The FairMed is a novel device and as such there are no existing data on effectiveness. It is difficult to establish what is a fair comparator to use in a trial with a new device. Whilst the Cochrane review of TENS concluded that there was limited evidence for TENS , there aThe findings of this trial demonstrate no significant difference in pain intensity reduction between the FairMed and TENS. This is in keeping with other trials investigating sensory changes, such as the findings of Guieu et al.  and Lund2, the FairMed stimulates a large region of the lumbar spine and underlying tissues, indicating that pain alleviation could be attributed to the activation of these receptors.The theory for the analgesic effect of TENS is suggested to be as a result of counter stimulation of the nervous system modifying the perception of pain . There iFunctional magnetic resonance imaging (fMRI) of subjects has revealed reduced activity in the anterior cingulated, insula and thalamus; some of the key pain processing areas of the brain. There is evidence to suggest that the same is true for cognitively demanding distraction. Bantick et al  reportedThe study was severely limited by the functionality and reliability of the prototype FairMed device. Of the 32 devices used, 13 had developed faults by the end of the trial. Of the 32 participants randomised to the FairMed group, 20 reported some kind of fault with its functionality. Feedback from users of the FairMed device will be used to develop a more reliable device. It would have been preferable for this information to have been gathered before the main trial, but this was not possible due to time restrictions.We recognise that this is a very difficult group to help and any treatment is likely to be of limited benefit. Commercially and practically it is difficult to demonstrate benefit in such chronic pain populations and very large studies are needed to show superiority. At the early stages in the development of a new and initially expensive device, a non-inferiority study is thus the only financially and practicably viable option. The main difficulties in the design and conduct of a non-inferiority trial are the demonstration of assay sensitivity, bias from lack of masking and difficulty in establishing the non-inferiority margin. As a consequence, the results of a non-inferiority trial are not as credible as those from a successful superiority trial ,33. HoweThe findings presented in this study are not able to demonstrate a reduction in chronic low back pain using the FairMed. None-the-less, cortical reorganisation through sensory discrimination may be a mechanism through which the FairMed could modulate CLBP. Further work to explore these mechanisms is still needed to expand our understanding of chronic pain and the role of neuro-modulation in the transition from acute to chronic LBP.The authors declare that they have no competing interests.Jeremy Fairbank has applied for a patent for the FairMed device and should the Fairmed device ever be marketed, he may benefit financially.JF and KB conceived, planned and secured funding for the study. CE collected all data and did the data analysis. CS supervised the data analysis and contributed to the manuscript preparation. KB co-ordinated the study and drafted the manuscript. All authors contributed to and approved the final manuscript.The pre-publication history for this paper can be accessed here:


The purpose of this study was to assess the curative and symptomatic efficacy of the prostacyclin analogue iloprost in BME and AVN patients.Bone marrow oedema (BME) and avascular osteonecrosis (AVN) are disorders of unclear origin. Although there are numerous operative and non-operative treatments for AVN, pain management in patients with AVN remains challenging. Prostaglandins play an important role in inflammatory responses and cell differentiation. It is thought that prostaglandin IWe are reporting on 50 patients (117 bones) affected by BME/AVN who were treated with iloprost. Pain levels before, during and 3 and 6 months after iloprost application were evaluated by a visual analogue scale (VAS). The short form(SF)-36 health survey served to judge general health status before and after treatment. Harris Hip Score (HHS) and Knee Society Score (KSS) were performed as functional scores and MRI and X-rays before and 3 and 6 months after iloprost application served as objective parameters for morphological changes of the affected bones.We found a significant improvement in pain, functional and radiological outcome in BME and early AVN stages after iloprost application, whereas patients with advanced AVN stages did not benefit from iloprost infusions. Mean pain level decreased from 5.26 (day 0) to 1.63 (6 months) and both HHS and KSS increased during follow-up. Moreover, the SF-36 increased from 353.2 (day 0) to 560.5 points (6 months). We found a significant decrease in BME on MRI scans after iloprost application.In addition to other drugs, iloprost may be an alternative substance which should be considered in the treatment of BME/AVN-associated pain. Avascular osteonecrosis (AVN) is a common and multifactorial disease, It has a high incidence, estimated to be 15,000 cases of AVN in the femoral head per year in the USA -4, alcohIt was shown by Ito and colleagues  that theAlthough there is consensus about the different vascular factors that contribute to BME and AVN, the pathogenesis and cause of pain remain unclear. However, the occurrence of associated AVN risk factors, distinct MRI findings, such as a subchondral area of low intensity of at least 4 mm in thickness and 12.5 mm in length, and a prolonged BME for more than 11 weeks correspond to the diagnosis AVN .Advanced stages of AVN can be diagnosed by x-rays showing sclerotic and/or osteolytic areas. Magnetic resonance imaging (MRI) is very sensitive in identifying and characterising BME and AVN in the early stages .2 ([PGI2] or synonoma prostacyclin) and its analogues promote bone regeneration on a cellular or systemic level.The success of different treatment concepts is strongly dependent on the stage of the disease, as classified by the Association Circulation Osseous (ARCO) Table  27-30].-30.27-30Preliminary promising results in the literature -37 and iBetween October 2002 and December 2005, 61 patients with painful BME or AVN (mean (SD) age = 45.9 (14.9) years; range = 11 to 76 years) were treated with iloprost. According to the study protocol, we carried out a prospective, MRI-controlled observational study on 50 patients (mean age = 45.2 (14.2) years; range = 24 to 76 years; sex ratio: 22 men to 28 women) with symptomatic AVN or painful BME. The average body weight was 73.5 (14.1) kg and the mean height was 172.0 (9.4) cm. All AVN were associated with an almost distinctive BME, which showed a high variability in extent and was not evaluated separately.Patients aged between 18 and 80 years with painful BME and additional AVN risk factors or BME persisting for more than six months or AVN stage greater than ARCO I were included in the study. Patients were excluded if they had acute or chronic infections or hypertension with systolic values higher than 160 mmHg, or those who had ischaemic heart attacks or cerebral ischaemia/bleeding within the past six months or surgery within the past six months or bleeding disorders, or if the women were pregnant or breastfeeding. Based on MRI scans, x-rays and clinical examinations, patients with osteoarthritis, joint instabilities and axis deformities 10° more than the statistical normal were also excluded. The study protocol was approved by the local Ethics Committee  and included written informed consent according to the Declaration of Helsinki in its present version.Iloprost  was dissolved in 0.9% saline solution and applied intravenously over a period of six hours per day in a weight-related schedule for a total of five days Table .Based on medical history and clinical examination, the Harris Hip Score (HHS), the Knee Society Score (KSS) and assessment of pain level on a visual analogue scale (VAS) served for evaluation during a follow-up of up to six months. The VAS is classified from 0 (no pain) to 10 (severe pain). Moreover the short form (SF)-36 health survey was used to assess patients' health status. It is the short form of an instrument developed for the Medical Outcome Study and contains 36 items that can be aggregated to eight scales .In addition to clinical parameters, plain radiographies in two standard planes (one when weight bearing) and MRI scans  weighted) were performed for radiographic analysis by a blinded independent radiologist (DB) . Table Any side effects and adverse events were recorded. Uneventful effects during or after iloprost therapy were recorded and classified as severe  and minor  side effects.t-test for independent statistical groups was used for statistical analysis: p < 0.01 was highly statistically significant, p < 0.05 was statistically significant and p > 0.05 showed no significance. The average values, standard deviations and the range from minimum to maximum readings served as descriptive parameters at follow-up examinations. Connections between the different parameters were recorded and determined by linear regression analysis.Student's Overall, 117 bones (98 joints) in patients in this study were affected by BME or AVN before treatment. Figure No severe adverse effects were observed in any patients during intravenous iloprost administration. In two patients, severe headaches occurred on infusion day four and led to early termination of iloprost therapy. We observed one thrombophlebitis at the injection site, which was treated with antiseptic patches and healed within four days. Flushes or erythemas occurred from day three in 90% of patients during infusion.Iloprost showed a highly significant reduction in the level of pain evaluated by VAS during intravenous application within five days starting from 5.3  before treatment (day 0) to 2.5  on average at day five. There was still an improvement in pain three and six months after infusion corresponding to a pain level on the VAS  but the reduction in pain in this period was not statistically significant (p > 0.05). Starting at day three, about 60% of all patients reported intermediate "gnawing and dull" sensations in the affected bones during iloprost application. These dysesthesias disappeared spontaneously within six hours when infusion was stopped. Figure There was a highly significant improvement in the mean HHS from 52.6 points  before treatment to 73.6 points  after three months and 79.9 points  after six months. In the period between three and six months after iloprost infusion, the HHS improvement was not significant (p > 0.05) as shown in figure Corresponding to a better functional outcome and a significantly lower pain level in BME and AVN patients, quality of life evaluated by SF-36 score showed significant improvement during and after iloprost infusion figure . The aveThe clinical findings during follow-up correspond to the MRI findings. After three and six months, MRI scans showed a significant decrease in the extent of BME. Overall, 65 of 117 affected bones were free of BME within six months of iloprost application. In contrast to a significant decrease in BME and early AVN stages, advanced AVN stages (ARCO III and IV) were not influenced by iloprost; however, in some patients with ARCO stages III and IV iloprost showed an analgetic effect. Figures The regression analysis reflects the strong negative correlation between pain level reduction and functional outcome, life quality and reduction of BME in MRI scans. The correlation coefficient between pain and the HHS was -0.99, between pain and the KSS it was -0.96, and between pain and the SF-36 it was -0.91. There were no substantial iloprost-mediated effects on joint cartilage in standard MRI sequences.in vivo of about 25 minutes, the clinical and MRI findings were not only short-term effects but lasted until the final follow up at six months after application. The high number of patients with multifocal AVN  in our study is partly due to the fact that 20% of individuals underwent kidney transplantation. All of these patients developed a multifocal painful BME  [During intravenous treatment with the prostacyclin analogue iloprost, a highly significant reduction of pain in patients with BME and/or AVN could be demonstrated. Moreover, iloprost showed a non-significant but progressive reduction of pain through to the last follow-up examination. As shown in the results, the anti-oedema effects of iloprost were dependent on the ARCO stage of the AVN. Patients in early ARCO stages I and II especially benefited from iloprost application with respect to pain relief, functional outcome and BME reduction. Although iloprost has a short half-life ndrome') .2 analogue iloprost in BME and/or AVN [Our results correspond to the data from other investigators. Disch and colleagues  reportedd/or AVN ,48,49.As an alternative treatment concept, some authors report good results after core decompression, based on the theory that AVN-associated pain is due to elevated intramedullary pressure ,50,51. AThe pharmacokinetic effects of iloprost that lead to better perfusion in tissue with a critical blood supply are multiple. It induces vasodilation and has an impact on rheological properties of the terminal vascular bed . Moreove2) is an important mediator implicated in bone metabolism which acts via the kinase A-pathway as a potent inhibitor of bone resorption and mediates bone modelling [2 on its IP receptor are well documented, there are few data available in the literature about the distribution of IP receptors in human bone. Fortier and colleagues [2-mediated effects.From a molecular point of view, the G-protein-coupled prostanoid IP receptor plays a crucial role in the prostacyclin-induced effects. Activation of IP receptors may result in pain sensation, inflammatory responses, inhibition of platelet aggregation and vasodilation in vascular tissue . Furtherodelling . Althouglleagues  detectedlleagues , IP recelleagues  demonstrThe IP receptor plays an important role in rat dorsal root ganglion (DRG) neuron sensitisation, which is measured by the release of the neurotransmitter substance P. Nakae and colleagues  showed t2), BMY 45778 and cicaprost, are also potent agents with IP-receptor binding properties and may influence pain [The interpretation of an osteoblast-protective effect caused by the prostacyclin analogue iloprost and its clinical relevance for pain relief in AVN is critical because the molecular pathways are complex. Other agents, such as the stable analogue carbacyclin , transient marrow oedema or merely reflects a subtype of AVN. The diagnosis of BME syndrome can only be made retrospectively, regardless of whether a progressive AVN or a BME syndrome will follow subsequently. Considering the similar clinical presentation of BME and AVN and the high variance in prognosis and therapeutic consequences between self-limiting BME syndrome and progressive AVN, we recommend applying iloprost with preference in BME patients with additional AVN risk factors or in persisting and painful BME.2 and related molecules. Appropriate MRI sequences such as dGEMRIC, which not only allow evaluation of bone-related effects but may also help to detect molecular changes within the complex cartilage histo-architecture, should be used in further investigations.We showed that osteonecrosis-associated pain can be treated sufficiently by the prostacyclin-analogue iloprost. Therapy in bone BME and AVN was only promising in early AVN stages (ARCO I and II). In addition to other drugs, iloprost may be an alternative substance that should be considered in the treatment of BME and osteonecrosis-associated pain. Further controlled clinical studies are needed to show if iloprost has any effects on joint cartilage and to investigate if osteoarthritis-related BME is an indication for future application of PGIIloprost improves the functional and radiological outcome in patients with BME. However, advanced AVN stages (≥ ARCO II) are irreversible and iloprost is not potent enough to heal the osteonecrotic areas. Although the individual risk for severe side effects during iloprost treatment is low when the dosage is adapted to the body weight, contraindications should be considered carefully.ARCO: Association Research Circulation Osseous; AVN: avascular osteonecrosis; BME: bone marrow oedema; DRG: dorsal root ganglion; HHS: Harris Hip Score; KSS: Knee Society Score; MRI: magnetic resonance imaging; PG: prostaglandin; SF: short form; STIR: short T1 inversion recovery; SLE: systemic lupus erythematodes; VAS: visual analogue scale.The authors declare that they have no competing interests.MJ worked out the design of the study and carried out the clinical investigations of the probands. FPT and GRH drafted the manuscript and performed part of the clinical investigation. TST edited the manuscript. MM, CZ and RK participated in the coordination and clinical investigation of the patients. DB carried out the evaluation of the x-rays and MRI scans. All authors read and approved the final manuscript.


To determine the methods of anesthesia currently being used by pediatric rheumatologists when performing intra-articular corticosteroid injections (IACI).A questionnaire was emailed to all members of the Childhood Arthritis & Rheumatology Research Alliance, a pediatric rheumatology research network in North America. The questionnaire consisted of 11 questions ranging from procedure technique, treatments prescribed for topical anesthesia and oral analgesia, and factors that might affect procedural pain.® cream plus subcutaneous lidocaine (58.8%), ethyl chloride spray only (39.7%), EMLA® cream only (33.8%), subcutaneous lidocaine only (25%), and lidocaine iontophoresis only (11.8%). Buffering of the lidocaine was routinely done only 7.4% of the time.Seventy-four of 161 physicians (46%) responded to the questionnaire. On average, each physician injected 33 children  and 43 joints  yearly. Local anesthesia was used in children on average ≥ 8 years (range 2-16 years), with general anesthesia being more frequently used for younger children. All respondents used local anesthesia. The most commonly used methods of local anesthesia were EMLAAlthough pediatric rheumatologists in North America perform IACI on a large number of patients each year, a wide variety of methods are used to deliver local anesthesia with no accepted standard of care. More studies are needed to determine the optimal method of local anesthesia delivery to minimize pain associated with IACI. Intra-articular corticosteroid injections (IACI) are one of the mainstays of treatment for children with chronic arthritis -7. IACI ® cream  or plastic wrap 60 minutes prior to the procedure. It has been shown to decrease the pain in a number of minor procedures in children [Local anesthetics used for IACI may include EMLA® cream , lidocai® cream  and subc® cream , as wellchildren . Althougchildren .Lidocaine iontophoresis is a safe, non-invasive way of delivering topical lidocaine. Low-level electrical current drives the lidocaine into the skin . It is bSome children, particularly very young children, or those undergoing injection of multiple joints, are sedated using such agents as propofol ,6, midazMembers of the Childhood Arthritis & Rheumatology Research Alliance (CARRA), a research network of all academic pediatric rheumatology centers in North America, received an 11 question self-administered, free response and multiple choice questionnaire between April and June 2005 either by email or distribution at the annual CARRA meeting inquiring about anesthesia for subjects receiving IACI. Questions pertained to procedure technique, medications prescribed for topical anesthesia, oral analgesia, the use of sedation, and factors affecting their use. The responding physician's beliefs regarding their patients' experience of pain during the procedure were examined, as were the important factors affecting the level of procedural pain as per the responding physician.Seventy-four of 161 physicians (46%) (55 from the USA and 15 from Canada) responded to the questionnaire. Respondents reported injecting a mean of 33 children  and 43 joints  yearly. Forty-three percent of physicians reported that they aspirate the joint to "dryness" prior to injecting corticosteroids. Local anesthesia was reported to be used in children with a median age of 8 years (2-16 years). Although a wide variety of local anesthetic methods were used  experience mild or no pain during IACI, with only 4% of patients experiencing severe pain. Sixty-seven percent of physicians believe that giving unbuffered subcutaneous lidocaine may actually increase procedural pain, but only 7% of physicians buffered the lidocaine. Other factors cited as potentially contributing to procedural pain included: patient (57%) and parent (68%) anxiety regarding the procedure, multiple joint injections at one time (38%), young patient age (57%), injection of small joints (10%), severity of the arthritis (7%), difficulty of aspiration/injection (4%), history of prior joint injection without the use of anesthesia (3%) and physician confidence and speed (3%). Forty-four percent of physicians prescribed oral analgesics routinely for use after the IACI. The type of analgesic used was not assessed.Although pediatric rheumatologists in North America perform IACI on a large number of patients each year, a wide variety of methods are used to provide anesthesia, and there is no accepted standard of care regarding the best methods to be used. Although most patients were thought to experience no pain or mild pain using various methods of local anesthesia, it is known that nurses and physicians often underestimate procedural pain .Many physicians were concerned that unbuffered subcutaneous lidocaine contributed significantly to the pain of the procedure, but very few attempted to prevent this pain by buffering the lidocaine. It is not known if physicians are unaware of the benefits of buffering the lidocaine or if it is impractical in the physician's office.It is interesting that less than half of the respondents aspirated the joint prior to injection, since Weitoft, et al found that synovial fluid aspiration reduces the risk of relapse in rheumatoid arthritis patients . There aLimitations of this study include responder bias and physician self-reporting. Little is known about the child or the parent's perception of pain during IACI using the different methods of anesthesia, and this study was not able to address this issue.Given the variety of methods used by pediatric rheumatologists, it is probable that there is a significant variation in the actual amount of procedural pain being experienced by children with JIA undergoing IACI. More studies are needed to address this issue and to determine the optimal methods of providing pain relief delivery during this commonly used procedure.The authors declare that they have no competing interests.JW contributed to the conception, design and coordination of the study and drafted the manuscript. YK contributed to the conception, design and coordination of the study. PM contributed to the conception and design of the study. AU contributed to the conception and design of the study and performed statistical analysis. All authors read and approved the final manuscript.


A rare case of proctalgia fugax with dysthymia which was successfully treated with dothiepin and other psychological interventions. Proctalgia fugax is characterized by uncomfortable rectal pain that appears suddenly at night.SK, a 61-year-old retired government employee, was referred for psychiatric consultation by a laparoscopic surgeon. He complained of severe, intractable anorectal pain for the past 3 years. The pain was severe, abrupt, sharp or gripping in nature and woke him up at night. The pain was localized, lasted for several seconds to 2–3 minutes and occurred 4–5 times a week. He was advised a warm bath or ice pack by a private practitioner but his symptoms remained unchanged. After 3 months, his family members consulted a surgeon and gastroenterologist. His general physical and systemic examination, as well as all routine and special investigations  were normal and he was diagnosed as having proctalgia fugax. He was given a course of tetanus prophylaxis, antibiotics and nitroglycerin ointment for local application. He stopped treatment because there was no improvement.On psychiatric evaluation, the patient was anxious and highly strung, and gave no history of psychiatric illness prior to the development of proctalgia fugax. He was found to have chronic low mood and fulfilled all the ICD-10 criteria for dysthymia.This patient presented with symptoms of anorectal pain. All other systemic causes of anorectal pain were ruled out on detailed evaluation. Anorectal and perineal pain can occur in the absence of organic disease.This is the first case report of proctalgia fugax with dysthymia and its successful treatment with combined therapy  from the Indian subcontinent. However, further studies are required in a large number of patients. This report highlights the need for more psychiatric research in patients with proctalgia fugax. Better collaboration between the surgical specialist and mental health professional is advocated when dealing with these patients.