HIV-associated distal sensory polyneuropathy (HIV-DSP) is the most frequently reported neurologic complication associated with HIV infection. NGX-4010 is a capsaicin 8% dermal patch with demonstrated efficacy in the treatment of HIV-DSP. Data from two phase III, double-blind studies were integrated to further analyze the efficacy and safety of NGX-4010 and explore the effect of demographic and baseline factors on NGX-4010 treatment in HIV-DSP.Data from two similarly designed studies in which patients with HIV-DSP received NGX-4010 or a low-concentration control patch (capsaicin 0.04% w/w) for 30 or 60 minutes were integrated. Efficacy assessments included the mean percent change from baseline in Numeric Pain Rating Scale (NPRS) scores to Weeks 2–12. Safety and tolerability assessments included adverse events (AEs) and pain during and after treatment.versus −15.7%, respectively. Patients who received a 60-minute application of NGX-4010 (n = 243) showed comparable pain reductions (−27.5%) to patients treated for 30 minutes, but this was not statistically superior to controls (n = 115). NGX-4010 was effective regardless of gender, baseline pain score, duration of HIV-DSP, or use of concomitant neuropathic pain medication, although NGX-4010 efficacy was greater in patients not receiving concomitant neuropathic pain medications. NGX-4010 was well tolerated; the most common AEs were application-site pain and erythema, and most AEs were mild to moderate. The transient increase in pain associated with NGX-4010 treatment decreased the day after treatment and returned to baseline by Day 2.Patients (n = 239) treated with NGX-4010 for 30 minutes demonstrated significantly (p = 0.0026) greater pain relief compared with controls (n = 100); the mean percent change in NPRS scores from baseline to Weeks 2–12 was −27.0% A single 30-minute application of NGX-4010 provides significant pain relief for at least 12 weeks in patients with HIV-DSP and is well tolerated.C107 = NCT00064623; C119 = NCT00321672 HIV-associated distal sensory polyneuropathy (HIV-DSP) is the most frequently reported neurologic complication associated with HIV infection. It can be caused by the virus itself  or by thHIV-DSP presents with predominantly symmetrical signs of distal sensory loss and reduction or loss of ankle reflexes. Symptomatic HIV-DSP reflects the involvement of both small and large sensory nerve fibers and includes distal painful dysesthesias, allodynia, severe burning pain, pins and needles, and numbness ,2. TheseIn a recent US study, 881 of 1,539 57%) individuals infected with HIV showed evidence of HIV-sensory neuropathy, which encompasses HIV-DSP caused by the virus and toxic DSP due to dideoxynucleoside antiretroviral therapy . Very fe% individNGX-4010 is a capsaicin 8% (w/w) dermal patch licensed in 2009 in the EU for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain; and indicated in the US for the management of neuropathic pain associated with post-herpetic neuralgia. NGX-4010 was developed to rapidly deliver a high dose of capsaicin directly to the source of pain with a single application. Capsaicin is a highly selective agonist for the Transient Receptor Potential Vanilloid 1 (TRPV1) receptor, which is a ligand-gated non-selective cation channel that is highly expressed in nociceptors and is critical for pain transmission and modulation . As a coversus the 30-minute control group. Although this did not attain statistical significance using a prespecified analysis of covariance (ANCOVA) model, it did show a significant difference (p = 0.035) when a post hoc non-parametric test was used [Two similarly designed phase III, double-blind, controlled studies have investigated the efficacy of NGX-4010 in patients with HIV-DSP. These studies demonstrated that treatment with NGX-4010 was well tolerated and resulted in a reduction in pain over 12 weeks ,23  score, CD4 cell count, viral load, and the percentage of patients receiving some form of concomitant neuropathic pain treatment at baseline were similar between the two phase III studies and between treatment groups within the two studies (NeurogesX unpublished data) ,23. The The percentage of patients terminating the studies before the end of the 12-week double-blind period was 8% for the combined NGX-4010 group and 8% for the combined control group  responded to NGX-4010 treatment (≥30% decrease in NPRS score from baseline to Weeks 2–12), but only the 30-minute NGX-4010 treatment resulted in a significantly greater percentage of responders compared with controls . The most common (≥2%) treatment-related AEs were application-site reactions, including pain, and erythema  NGX-4010-treated patients and three (3%) control patients reported one or more serious adverse event (SAE). In the 60-minute treatment groups, 19 (8%) NGX-4010-treated patients and eight (7%) control patients reported one or more SAEs. None of the reported SAEs was considered to be related to the study drug.No clinically important mean changes in hematology, serum chemistry, or vital signs were observed in the NGX-4010 or control groups except for small transient elevations in mean systolic and diastolic blood pressure (<4 mmHg) during and shortly after NGX-4010 application.versus 31%, p < 0.0001). The percentage of patients using medication for treatment-related discomfort was lower in the 30-minute NGX-4010 group compared with the 60-minute treatment group .NGX-4010 was well tolerated. Nearly all patients in both the 30- and 60-minute NGX-4010 groups completed at least 90% of the intended NGX-4010 application duration Table . DetaileAs expected, on the day of treatment there were significant differences in the distribution of maximum dermal assessment scores between the total NGX-4010 and control groups (p < 0.0001). A total of 60% of NGX-4010-treated patients and 44% of control patients had a maximum dermal assessment score of >0. Dermal irritation was commonly mild in the NGX-4010-treatment groups, with dermal assessment scores ≥2  being reported in only a few patients .The similarity of the demographic and baseline characteristics of the patients from the two multicenter, randomized, double-blind, controlled phase III studies Table , togetheThe reduction in NPRS score following the 60-minute application of NGX-4010 was not significantly different from control. This is likely due to the large effects of the control patch observed in study C119 . InteresThe data presented here show no evidence of increased efficacy with increased NGX-4010 treatment duration and support the selection of the 30-minute dose for treatment of peripheral neuropathic pain in patients with HIV-associated neuropathy. By contrast, for patients with post-herpetic neuralgia who typically experience neuropathic pain on the torso as opposed to the extremities, treatment duration is 60 minutes ,28.A transient increase in pain compared with baseline was seen on Day 0 in patients receiving NGX-4010, due to the treatment procedure. However, treatment-related pain was short-lived, with NPRS scores for patients treated with NGX-4010 for 30 minutes returning to baseline by Day 2. Thereafter, NPRS scores in patients receiving a 30-minute NGX-4010 application continued to decline and NGX-4010-treated patients achieved a greater pain reduction than those in the control group by Day 5 and on each subsequent day through Day 84. Weekly NPRS scores demonstrated significantly greater reductions in pain for NGX-4010-treated patients compared with controls each week from Week 2 to study completion (Week 12).Subgroup analyses showed greater pain reduction in patients treated with NGX-4010 compared with those treated with control in all subgroups regardless of gender, baseline pain score, concomitant neuropathic pain medication, and HIV-DSP duration. However, NGX-4010 was more effective in patients not using concomitant neuropathic pain medications compared with those using concomitant neuropathic pain medications. This result is not unexpected as it has been shown previously that the additional reduction of neuropathic pain obtained with an add-on drug is generally not as large as the benefit obtained with monotherapy ,30. ThisAlthough NGX-4010 application does cause some treatment-related pain, it is generally mild or moderate and transient. The vast majority of patients were able to tolerate >90% of the intended NGX-4010 application. Most common treatment-related AEs were application-site reactions; systemic effects were limited to small, transient elevations in mean systolic and diastolic blood pressure shortly after NGX-4010 application due to treatment-associated increases in pain.With the current lack of effective treatment for pain associated with HIV-DSP, a therapy such as NGX-4010, which can deliver rapid and prolonged pain relief for at least 3 months after a single 30-minute application, may be of great benefit to patients with HIV-DSP. In addition to its efficacy, there are few systemic AEs associated with NGX-4010 , unlike Details of each of the studies included in this analysis have been reported previously ,23. BothBoth studies recruited patients who were ≥18 years of age with a diagnosis of HIV-DSP for ≥2 months and an average baseline NPRS score  of 3–9. 2, 8% w/w; NeurogesX, Inc., San Mateo, CA, USA) or a low-concentration control patch . The control patch produced local erythema and a burning sensation to provide effective blinding in the studies.Patients were randomly assigned to receive treatment with an NGX-4010 (QUTENZA™/Qutenza®) patch  for 60 minutes before patch application. Both the NGX-4010 and control patches were applied for 30, 60, or 90 minutes in study C107  and for The studies included either a ≥5 day  or ≥14 dOther efficacy measurements included the percentage of patients with ≥30% mean decrease in NPRS score from baseline during Weeks 2–12 and the percentage of those feeling improved according to the PGIC at Week 12. In this assessment patients reported how they felt after treatment compared with before treatment on a 7-point scale with −3 indicating “very much worse” to +3 indicating “very much improved” and 0 indicating “no change”.Safety and tolerability assessments included AEs, vital signs, clinical laboratory tests, physical examination, dermal assessment (0- to 7-point severity score) , “pain nData from patients receiving NGX-4010 and control patches for 30 or 60 minutes were integrated from both phase III HIV-DSP studies. The 90-minute NGX-4010 dose was not included in these analyses as it was not evaluated in study C119 . Intent-Missing post-treatment NPRS scores were imputed using a modified last observation carried forward approach. If the NPRS score was missing on post-treatment Days 0–8 or on Day 8 and one or more consecutive days, then the baseline score was imputed for those days. If the NPRS score was missing for any day after Day 8, then the missing score was imputed by the last available non-imputed score recorded before that day. If all post-treatment NPRS scores were missing (including Day 0), all scores were imputed using the baseline score. NPRS baseline scores were calculated using all available screening scores that were not biased by pain medication changes  or usingThe percentage of responders (classified as those achieving ≥30% reduction in NPRS score from baseline) was compared between groups using logistic regression analyses, with baseline pain score, gender, pre-topical anesthetic pain score, and percent change in pain score after topical anesthetic treatment as covariates. In addition, odds ratios and the 95% CI of observing responses in the NGX-4010 group compared with the control group were estimated. The percentage of patients reporting improvements according to the PGIC was compared between treatment groups using Fisher’s exact test. For both the primary endpoint and responder analysis, the treatment effect was assessed by gender, baseline pain score (median NPRS score of < and ≥6.07), HIV-DSP duration (median of < and ≥5.2 years), and concomitant neuropathic pain medication use at study entry  in patients treated for 30 minutes.AEs were coded using the Medical Dictionary for Regulatory Activities version 9.0. Medication use for treatment-related discomfort (from Days 0–5) and the percentage of patients completing the intended patch duration were compared using Fisher’s exact test. The percentages of patients reporting each level of dermal response were compared using the Cochran–Mantel–Haenszel test. The maximum changes in “pain now” NPRS score from the pre-topical anesthetic time point during and after patch application were summarized and compared using the Wilcoxon rank sum test.Patients were analyzed as randomized for the efficacy analyses and as treated for the safety analyses.AE: Adverse event; ANCOVA: Analysis of covariance; CI: Confidence interval; HIV-DSP: HIV-associated neuropathy; LS: Least square; NPRS: Numerical Pain Rating Scale; OR: Odds ratio; PGIC: Patient Global Impression of Change; rhNGF: Recombinant-human nerve growth factor; SD: Standard deviation; SE: Standard error; TRPV1: Transient Receptor Potential Vanilloid 1.DMS has received consultancy fees and/or honorarium or speaker fees from NeurogesX, Astellas Pharma Europe Ltd., Eli Lilly and Pfizer. DMS’s institute has received grants from NeurogesX, Astra Zeneca and Pfizer. MF has received speaker fees and funding to attend a conference from Astellas. SB’s institute, AIDS Research Alliance, received grants to conduct the research. GS received funds as site investigator. JKT and GFV are former employees of NeurogesX and still own stock in NeurogesX.SB, DMS, GM, BJB, GS, NL, CO, and MF conducted the study, interpreted the data, and edited the manuscript. GFV and JKT designed the study, analyzed and interpreted the data, and prepared the manuscript. All authors read and approved the final manuscript.


Standard assessments for fibromyalgia (FM) diagnosis and core FM symptom domains are needed for biomarker development and treatment trials. Diagnostic and symptom assessments are reviewed and recommendations are made for standards. Recommendations for existing assessments include the American College of Rheumatology FM classification criteria using the manual tender point Survey for diagnosis, the brief pain inventory average pain visual analogue scale for pain intensity, the function subscale of the revised fibromyalgia impact questionnaire (FIQR) for physical function, the patient global impression of change and FIQR for overall/global improvement, the hospital anxiety and depression scale depression subscale for depression, the multiple ability self-report questionnaire for cognitive dysfunction, the fatigue severity scale for fatigue, the FIQR for multidimensional function/health-related quality of life, the jenkins sleep scale for sleep disturbance, and the fibromyalgia intensity score for tenderness. Forthcoming assessments including the FIQR for diagnosis, NIH PROMIS, and FIBRO Change scales are discussed. Fibromyalgia (FM) is one of the most challenging disorders to manage. Treatment advances are needed to improve the care of FM patients. FM is currently a very subjective disorder, and the development of biomarkers could improve care by simplifying FM diagnosis and objectively quantifying symptom severity. Numerous FM biomarkers have been proposed . However2 of force. However, performance of the classification criteria in clinical diagnosis is poor, failing to identify almost half of FM patients . Th. Th12]. While recommendations for core symptom domains exist, there are no accepted standards for assessments to evaluate these domains. Standard measures are needed against which biomarkers can be compared for development and to allow direct comparisons between treatment trial results. Published work to develop a consensus set of FM outcome measures has been limited to two papers , 14. TheThe work by Carville and Choy reviewed 185 FM trials to identify assessment instruments for core FM domains that were sensitive to change for both pharmacologic and nonpharmacologic treatments . The autThe initiative on methods, measurement, and pain assessment in clinical trials (IMMPACT) has provided recommendations for questionnaires to be used in interpreting the clinical importance of therapeutic outcomes in clinical trials of chronic pain treatments that may be applicable to FM . IMMPACTIMMPACT recommends the multidimensional pain inventory (MPI)  and the The patient global impression of change scale (PGIC) is IMMPACT recommended for evaluating participant ratings of overall improvement in pain treatment trials . The PGIDiagnostic and Statistical Manual on Mental Disorders (DSM-IV) criteria for major depressive disorder [DSM-IV criteria . The BDI-II has been linguistically validated into 12 languages for use in international FM treatment trials [The beck depression inventory (BDI) is the IMMPACT recommended depression assessment for pain treatment trials . The BDIdisorder . The BDIt trials . NormatiWhile the BDI is recommended for use in pain treatment trials and has been used in FM trials , it is nThe HADS depression subscale has been used previously to evaluate change in depressive symptoms in FM treatment trials . The HADWhile the HADS-D has not been specifically validated in FM patients, its validity to quantify depression symptoms has been shown in a variety of patient populations including somatic, psychiatric, and primary care patients and in the general population . The HADCore FM domains that lack published recommendations for self-report questionnaires include cognitive dysfunction, fatigue, multidimensional function/HRQoL, sleep, and tenderness. While numerous assessments exist for each domain in the literature, most were developed for use in patient populations other than FM. This is significant, since concepts and psychometric properties of a measure may not hold across patient populations. While cognitive dysfunction is a significant problem for many FM patients, assessment in large clinical trials has been hindered by the time and expertise required to perform the complex neurocognitive tests that can quantify cognitive dysfunction in FM . The mulNumerous self-report questionnaires have been used to assess fatigue severity in FM treatment trials including the multidimensional fatigue index (MFI) , the mulThe MFI is a 20-item scale that covers 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Four items in each subscale are answered on a 5-point Likert scale with item scores summed to yield subscale scores and a total score that varies between 20 and 100 with higher scores indicating more severe fatigue symptoms. The MFI is reliable and valid in FM patients , and it http://www.son.washington.edu/research/maf/). The MAF is available in 25 different language versions for various regions of the world, allowing for use in international research. While no published validation studies of the MAF in FM patients exist, a study of the MAF in 663 FM patients presented at EULAR in 2002 supports use of the MAF in the assessment of FM patients [The MAF is a 16-item scale  that measures 4 dimensions of self-reported fatigue: severity (2 items), distress (1 item), timing , and degree of interference with activities of daily living  . The glopatients . The FSS is a 9-item unidimensional measure of fatigue that is the most often used fatigue-specific scale in chronic diseases , 45. TheWhile all 3 scales were designed to measure fatigue symptoms, they differ considerably in their composition and foci. While the MFI is the most comprehensive of the 3 fatigue scales, questions have been raised about its dimensional structure, and it appears that MFI may only discriminate between two fatigue dimensions . Also, tIn contrast to the MFI, both the MAF and the FSS instruct patients to answer questions based on their fatigue symptoms, and every question specifically asks about fatigue, making the MAF and FSS more specific fatigue measures than the MFI. The MAF and FSS have both been recommended for the measurement of fatigue in chronic illnesses based on their good psychometric properties and demonstrated ability to detect change over time . HoweverThe FSS is the recommended fatigue severity measure in multiple disorders with associated fatigue including systemic lupus erythematosus  and ParkThe FIQ is recommended as a primary efficacy endpoint measure in FM clinical trials  and is tWhile the FIQ is universally used in FM trials, problems with the questionnaire exist. FIQ scoring is complex. The 11 physical function items are each scored on a 4-point Likert scale ranging from “always” (score of 0) to “never” (score of 3). Scores on the physical function items are summed, divided by the number of questions answered, and then multiplied by 3.33 to yield a 0-to-10 composite physical function score. The “felt good” “day-of-the-week” item is reverse scored (to obtain the number of days patients felt bad), and the result is multiplied by 1.43 to yield a 0-to-10 score. The “missed work” “day-of-the-week” item is derived by multiplying the number of days by 1.43 to yield a 0-to-10 score. The VASs are scored by measuring the distance from the beginning of the line to the patient's mark in centimeters. FIQ global scores are derived by summing the 0-to-10 composite physical function, “day-of-the-week,” and VAS item scores to yield a 0-to-100 score with higher scores indicating more severe FM. In order to maintain a maximum possible score of 100, an “equalization calculation” is used if patients did not answer all 10 sections by multiplying the global score by 10 and dividing by the number of sections answered. Content problems in the FIQ have also been raised . The phyTo address shortcomings of the original FIQ, the authors have published a revised FIQ, the FIQR . The FIQSleep problems are almost universal in FM, occurring in 95% of patients . Since dThe MOS Sleep Scale is a 12-item questionnaire designed to evaluate key sleep domains by assessing sleep latency (2 items), duration, quality (4 items), snoring, awakening short of breath or with headache, and daytime somnolence (3 items) over the past month  or week The FOSQ is a 30-item self-report questionnaire designed to measure the impact of daytime sleepiness on activities of daily living in people with sleep disorders using functional status categories including general productivity, activity level, vigilance, social outcomes, and intimacy and sexual relationships . Each itThe JSS is a 4-item self-report questionnaire designed to measure how often a subject has experienced sleep problems in the past month . JSS ite2 of force [Tenderness is a defining feature of FM patients, defined by the 1990 ACR criteria as pain upon palpation at standard tender point sites with 4 kg/cmof force . Howeverof force , 60. Thiof force , 62. Change in the severity of pain at tender point sites has been shown to be a better measure of tenderness than change in the number of tender points. The manual tender point survey (MTPS) is a standardized approach to performing the tender point exam in which FM patients rate pain severity upon digital palpation of each tender point on a verbal 11 point NRS . Pain seWhile newer assessments currently under development may prove superior for evaluating tenderness, such as the multiple random staircase-evoked pain measure , they reAs previously discussed, it is currently challenging to compare results across different treatment trials since different measurement tools are commonly used that often have noncomparable or noncombinable scores. This limitation of clinical trials is well known and not exclusive to FM. Two routes have been taken to solve this problem: (1) require a standard set of existing assessment tools to be used in treatment trials or (2) develop a new set of assessment tools for use in clinical trials. While groups like IMMPACT have taken the first route and made recommendations for the use of existing assessment tools , these rThe US National Institutes of Health roadmap project Patient-Reported Outcomes and Measurement Information System (PROMIS) has taken the second route to address the need for uniform assessment measures in clinical trials. PROMIS is a 5-year cooperative group program of research designed to develop, validate, and standardize item banks to measure patient-reported outcomes relevant across common medical conditions . The PROWhile PROMIS is being developed, the athens insomnia scale (AIS) should be studied for use in assessing sleep disturbance in FM patients . The AISHigh ceiling effects are typically seen when assessments are used to quantify symptom severity in FM patients. As an example, the ceiling effect on the JSS total score was found to be 27% in an FM treatment trial . AssessmObjective biomarkers and new treatments are needed to improve the diagnosis and management of FM. However, research standards for FM clinical diagnosis and core FM symptom domain assessments are needed to enable development of biomarkers and new treatments. Since standards for FM diagnosis and symptom assessment do not exist, these recommendations are intended as a starting point for discussions that will lead to the development of standards. While none of the assessments discussed herein are perfect, consensus within the FM research community must be reached if timely advances for improving patient care are to be made. The 1990 ACR FM classification criteria performed using the manual tender point survey (MTPS) standardized method incorporating the fibromyalgia intensity score (FIS) is the recommended method for clinical diagnosis since the 1990 criteria are well established, and the method can be performed without any specialized equipment. Recommended assessments for core FM symptom domains include the brief pain inventory average pain visual analogue scale for pain intensity, the physical function subscale from the revised fibromyalgia impact questionnaire (FIQR) for physical function, the patient global impression of change (PGIC) and FIQR for overall/global improvement, the depression subscale of the hospital anxiety and depression scale (HADS-D) for depression, the multiple ability self-report questionnaire (MASQ) for cognitive dysfunction, the fatigue severity scale (FSS) for fatigue, the FIQR for multidimensional function/health-related quality of life, the Jenkins Sleep Scale (JSS) for sleep disturbance, and the MTPS-FIS for tenderness. It is hoped that these recommendations will provide an impetus for the development of universally accepted standards of FM clinical diagnosis and symptom domain assessments that can provide the foundation for the development of objective FM biomarkers and new more effective treatment regimens.


Pain is a negative factor in the recovery process of postoperative patients, causing pulmonary alterations and complications and affecting functional capacity. Thus, it is plausible to introduce transcutaneous electrical nerve stimulation (TENS) for pain relief to subsequently reduce complications caused by this pain in the postoperative period. The objective of this paper is to assess the effects of TENS on pain, walking function, respiratory muscle strength and vital capacity in kidney donors.Seventy-four patients will be randomly allocated into 2 groups: active TENS or placebo TENS. All patients will be assessed for pain intensity, walk function (Iowa Gait Test), respiratory muscle strength  and vital capacity before and after the TENS application. The data will be collected by an assessor who is blinded to the group allocation.This study is the first to examine the effects of TENS in this population. TENS during the postoperative period may result in pain relief and improvements in pulmonary tests and mobility, thus leading to an improved quality of life and further promoting organ donation.Registro Brasileiro de Ensaios Clinicos (ReBEC), number RBR-8xtkjp. Organ donation has grown exponentially in Brazil, which is directly reflected by the significant increase in the number of transplants. A successful transplant affects both the lifespan and quality of life of patients. A renal graft from a living donor provides a 10 to 12% better chance of survival at one year .The postoperative complications in patients who underwent nephrectomy can be divided into mechanical, pulmonary, vascular and operative wounds . The majTranscutaneous electrical nerve stimulation (TENS) is considered to be a non-pharmacological intervention strategy used for physical therapy pain relief with minimal side effects . The useThere has been a significant increase in the rate of kidney transplants performed using living donors in recent years, raising questions regarding the short- and long-term effects of this procedure, such as whether there would there be a difference in pain intensity or changes in pulmonary function and donor independence or functionality in the postoperative period after the use of TENS. Moreover, no previous studies were found in the literature that investigated the effects of TENS in this population. For these reasons, we decided to conduct a prospective randomized controlled study to follow kidney donors who underwent lumbotomy or subcostal nephrectomy to evaluate the effect of TENS on pain, walking function, respiratory muscle strength and vital capacity.This study is a prospective randomized controlled and double-blind. Seventy-four patients will be randomly distributed into two groups: active TENS + analgesics (n = 37) and placebo TENS + analgesics (n = 37). Randomization will be performed by an investigator not involved in data collection using the sequentially numbered, opaque sealed envelopes (SNOSE) allocation concealment method ,17. PatiAll patients will be advised on the assessments that will be performed, including general information on the surgical procedure . The study flow diagram is presented in Figure This study will be conducted in the Kidney and Hypertension Hospital - Oswaldo Ramos Foundation, a supplementary service of the Federal University of Sao Paulo. The study will include 74 living kidney donors who underwent nephrectomy performed by two approaches: lumbotomy and the subcostal route. The route choice is dependent on the team performing the procedure, and these teams operate alternately on weekdays.• All living kidney donors undergoing nephrectomy by lumbotomy or the subcostal route;• At least 18 years old and of either sex;• Without acute or chronic pulmonary disease;• Ability to perform the necessary physiotherapy maneuvers and measures;• Pain intensity at rest greater than or equal to 2 and less than or equal to 7 on a numeric rating scale (0–10)• All living kidney donors who have previous experience with TENS;• Need for surgical intervention on another organ in addition to the kidney;• Surgical reintervention during the data collection period;• Required mechanical ventilation for more than 12 hours;• Died within 6 hours of the operationThe use of active TENS will be conducted with a Neurodyn Portable TENS unit (IBRAMED) with two channels. The generator emits asymmetric, balanced, biphasic pulses. Two self-adhesive electrodes (VALUTRODE - 9 × 5 cm) will be placed in parallel on both sides of the incision with a 3-cm distance between them. The duration of the TENS application will be 1 hour at a frequency of 100 Hz and a pulse duration of 100 microseconds . The intThe use of the placebo TENS will be performed with an apparatus identical in appearance to the active TENS  that is specially designed for this study. The device remains active only during the first 30 seconds of application. After the initial 30 seconds, the current amplitude will gradually decrease over 15 seconds until it reaches the zero value, thereby interrupting the emission of electric current. The unit will remain inactive for the rest of the application . The plaThey will be asked every 10 minutes about the intensity of TENS, reinforcing the idea that lack of sensation occurs in most cases due to habituation to the electric current. Patients will be observed throughout the administration of TENS . The modPrimary outcome: pain intensityTo evaluate pain intensity, an 11-point numeric rating scale (NRS) will be used, where 0 represents no pain and 10 represents the most intense pain imaginable. The assessment will be conducted at rest, during coughing and during respiratory tests  and walking function (Iowa Gait Test) before and after administration of TENS .Secondary outcomes: respiratory muscle strength, vital capacity and walk function2O  and with the patient in the seated position with relaxed arms and a disposable mouthpiece and nasal opening for the air leak.Patients will be assessed for their respiratory muscle strength , maximal expiratory pressure (PEmax)) and vital capacity (VC). PImax and PEmax will be assessed with an analog manovacuometer (MTR) with an operating range of 300 cmHTo measure the inspiratory muscle strength (PImax), the patient will be asked to perform a maximal expiration to the level of residual volume (RV) and then perform a maximal inspiratory effort, which must be maintained for approximately one second. To measure expiratory muscle strength (PEmax), the patient will be asked to perform a maximal inspiration at the level of total lung capacity (TLC) and then perform a maximal expiratory effort, which must be maintained for approximately one second ,22,23. TThe vital capacity (VC) will be measured with a spirometer (Wright Mark 8) with the patient in a seated position and connected to a disposable mouthpiece and nose clip to prevent air leakage. The test starts with inspiration to TLC, followed by expiration to the RV. The greatest of three consecutive measurements will be considered ,22,23.Assessment of walking function will be performed using the Iowa Gait Test. Patients will be assessed on three items: walking speed, distance travelled and level of assistance while walking for 15 seconds . The eva• Independent, no assistance• Minimal assistance, one point of contact • Moderate assistance, two points of contact • Maximum assistance, three or more points of contact 2) will be monitored through a pulse oximeter (Nonin Onyx 9500) to ensure proper oxygen saturation during the test. If the SpO2 drops below 92% or 10% of the baseline, the test will be stopped.The saturation of peripheral oxygen  by an investigator who is blind to group allocation.The statistical analysis will be performed on an intent-to-treat basis. The effects of the intervention on pain intensity, pulmonary function, and walking capacity, will be calculated using independent samples t tests for normally distributed data. Data not normally distributed will be compared using Mann–Whitney U tests. The level of significance will be set at The use of TENS during the postoperative period has become more common in various types of surgery in recent decades ,14,26,27An improvement in respiratory muscle strength and increased pulmonary volumes and capacity, in addition to a reduction of pain after the use of low-intensity TENS was observed in the postoperative period of cardiac surgery. This study also showed that the group that underwent TENS experienced significant increases in both PImax and PEmax compared to the control group . The effThe use of TENS increases the analgesic effect in patients undergoing a thoracotomy, providing an important analgesic strategy for the treatment of acute postoperative pain ,28,30,31Here, we present the rationale and design for a randomized controlled trial comparing the effects of active TENS versus placebo TENS in patients undergoing nephrectomy. This is the first study to be conducted on the use of TENS in this population. The results of this study will be published when it is completed.TENS: Transcutaneous electrical nerve stimulation;SNOSE: Sequentially numbered, opaque sealed envelopes;NRS: Numeric rating scale;PImax: Maximal inspiratory pressure;PEmax: Maximal expiratory pressure;VC: Vital capacity;RV: Residual volume;TLC: Total lung capacity;SpO2: Saturation of peripheral oxygen;PEF: Peak expiratory flow;FVC: Forced vital capacity;FEV1: Forced expiratory volume in 1 secondThe authors declare that they have no competing interests.REL, LDC and TTG were responsible for conceiving and designing the study. REL and LDC are the study coordinators. TTG and NRS are responsible for data collection. All authors have contributed for writing and approved this manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2369/14/7/prepub


Introduction. Celiac plexus neurolysis is used in pain management of patients with advanced and unresectable pancreatic cancer. We retrospectively analyzed efficacy and safety of endoscopic ultrasound- (EUS-) guided celiac plexus neurolysis in patients treated in our unit. Methods. Twenty nine subjects with unresectable pancreatic cancer and severe pain despite pharmacological treatment underwent EUS-guided celiac plexus neurolysis with 98% ethanol. Patients scored their pain according to a 0–10 point scale and were interviewed 1-2 weeks and 2-3 months after the procedure. Results. Twenty five (86%) patients reported improvement in their pain at 1-2 weeks following the procedure. Of these, 7 (24%) reported substantial improvement (decrease in pain by more than 50%) and 4 (14%) complete disappearance of pain. Pain relief was still present in 76% of patients after 2-3 months. Treatment-related side effects included hypotonia in 1 patient, severe pain immediately postprocedure in 2 patients, and short episodes of diarrhea in 3 patients. Conclusion. Endoscopic ultrasound- (EUS-) guided celiac plexus neurolysis is a safe and effective treatment of severe pain from advanced pancreatic cancer. Treatment of pain in patients with advanced pancreatic cancer is one of the most important goals of palliative care. It is estimated that pain occurs in 80–85% of patients with unresectable pancreatic tumors , 2. Desp Percutaneous celiac plexus neurolysis was first performed by Kapisa in 1914. Since then, it has been performed by many techniques for access, and with a variety of chemicals . PercutaIntraoperative celiac plexus neurolysis during surgery is seldomly used because in most cases, the diagnosis of unresectable pancreatic cancer is established without the need for laparotomy. Such patients usually require endoscopic stenting of the biliary tree and adequate pain control . Endoscopic ultrasound- (EUS-) guided celiac plexus neurolysis was first described by Wiersema in 1996 . The autWe aimed to assess the safety and efficacy of EUS-guided celiac plexus neurolysis for pain management in patients with advanced and unresectable pancreatic cancer. This is the first reported experience with this technique in Poland.Thirty two patients diagnosed with advanced and unresectable pancreatic adenocarcinoma were selected as candidates for EUS-guided celiac plexus neurolysis. The indication in all cases was severe abdominal pain requiring the use of opioids. Neurolysis was not performed in 3 patients because of the inability to visualize the celiac plexus with EUS due to atypical anatomy. Thus, between May 2008 and May 2009, 29 patients ultimately underwent EUS-guided celiac plexus neurolysis. All procedures were performed by 2 gastroenterologists (A. Wiechowska-Kozłowska and P. Milkiewicz) with extensive experience in EUS (both performed more than 1000 examinations). The linear type EUS endoscope (Olympus GF-UCT 160-OL5) with “spray” needles  was used in all cases.n = 13; 45%), the head and body , the body , and the tail of the pancreas  was made based on abdominal computed tomography and EUS. Tumors were considered unresectable when distant metastases and/or locally advanced tumors were present . Eighteen (56%) patients had advanced local disease and 14 (44%) were diagnosed with metastasis disease. Adenocarcinoma of the pancreas was confirmed in all patients with fine-needle aspiration biopsy under percutaneous (n = 11) or endoscopic (n = 18) ultrasound guidance. 11 (38%) patients underwent palliative chemotherapy with gemcitabine.Fourteen (48%) men and 15 (52%) women, mean age 62 (range 33–81) years, underwent the procedure. The diagnosis of advanced and unresectable cancer of the pancreatic head (Contraindications to the procedure included coagulation disorders (INR > 1.5), platelet count <50,000, or previous disease and treatment of the upper gastrointestinal tract that would make endoscopic access impossible. These contraindications were not present in included patients. After discussing the principles of the procedure, its consequences, the possibility of partial or no reduction of pain, and complications, informed consent was obtained in all patients. The procedure was performed in the left lateral position after intravenous administration of 2.5 mg of midazolam. Clinical parameters such as heart rate, blood pressure, oxygen saturation, and ECG were routinely monitored during the procedure. The antibiotics prophylactic was not used. The first stage was assessment of tumor location, confirming its advanced and unresectable stage . AnatomiAfter the procedure, patients were observed for 24 hours, with clinical evaluation and measurement of vital signs. 27 patients were discharged on the next day while 2 patients remained in the hospital for 2 days due to exacerbating pain. All the patients were instructed to attempt to gradually discontinue the use of pain medication. The assessment of efficacy and related morbidity was based upon a survey carried out prior to the procedure; on day 1, 1-2 weeks, and 2-3 months following the procedure. The effectiveness of treatment was assessed based on the 11-point pain scale . The reduction or discontinuation of pain medication was also considered. The incidence and types of complications were evaluated by clinical evaluation during and after the procedure, and by surveying all patients on the degree of pain, changes in bowel movements, neurological disturbances, and other clinical symptoms. Analysis was retrospective and was based on the hospital and endoscopy suit charts.An average pain score of 7.9 (range 6–10) was observed in all patients prior to the procedure, requiring the use of nonsteroid anti-inflammatory drugs and narcotic analgesics. One-two weeks following treatment, full pain resolution (0-1 points) was observed in 4 (14%) patients, who completely stopped taking pain medications. Seven (24%) patients had a reduction in pain by more than 50% while 9 (31%) patients had a reduction in pain by 30–50%. In 5 (17%) patients, a small improvement (reduction of pain by <30%) was found. In 4 (14%) patients, pain remained unchanged. Two-three months following the procedure, 4 patients died due to disease progression. These included 1 patient in whom neurolysis was fully effective, 1 patient with pain reduction by 30–50%, 1 patient with pain reduction of <30%, and 1 in whom the procedure was ineffective. Subsequent assessment (2-3 months postprocedure) was performed in 25 patients. Two (8%) patients were pain free and 5 (20%) patients maintained pain relief of more than 50%. Seven (28%) patients reported a 30–50% pain reduction while 5 (20%) and 6 (24%) patients had slight (<30%) or no improvement, respectively .A short but significant episode of hypotension requiring intervention occurred in 1 patient immediately after procedure. This normalized after treatment with an i.v. saline. Two patients reported a temporary but significant increase in pain immediately after procedure, requiring analgesics in increasing doses during the hospital stay. Both patients were discharged home after two days. One patient was pain free at discharge and 1 had a significant (>50%) reduction in pain. Three patients reported an increased frequency of bowel movements (4-5 stools daily) although no chronic diarrhea was observed in any patient.Celiac plexus neurolysis for pain management has been used for almost 100 years in patients with advanced abdominal malignancy . The proThe ideal procedure should preferably be highly efficacious, with low complication rates, and the least invasive. Proper visualization of the celiac plexus followed by precise administration of proper pharmacological agents all appear to be fundamental prerequisites for successful and safe neurolysis. Alcohol ablation is approximately twice as effective, compared with ablation using phenol . MoreoveWiersema was pioneered celiac plexus neurolysis under EUS guidance in 1996, demonstrating high efficacy in patients with advanced abdominal malignancy (significant pain reduction in 79–88%) with low morbidity .In our study, the effectiveness observed early following treatment appeared lower, since significant pain reduction was reported in 69% of patients, while 31% had slight or no improvement. Late response to treatment, assessed 2-3 months following the procedure, was significant in a relatively large (56%) number of patients. The inability to completely control the pain in all patients as well as reduction of pain relief over time was observed in several studies , 13, 20. Optimal timing for EUS-guided celiac plexus neurolysis is controversial. As in our study, it may be applied in a very advanced stage in patients requiring narcotic analgesia. Some authors, however, recommend the performance of neurolysis early in the course of disease, before pharmacotherapy with opioids has even been started , 16, 17. Our study shows that EUS-guided celiac plexus neurolysis is associated with a very low risk of complications. There was no significant treatment-related morbidity observed in any patients. EUS-guided celiac plexus neurolysis is a safe and effective treatment of severe pain in patients with advanced pancreatic cancer. It provides significant short-term pain relief in the majority of patients. However, its efficacy is limited, indicating the need for further studies aimed at improving the method.


Objective: To Compare the Specific Lumber Mobilization (SLM) techniques and Core-Stability (CS) Exercises with Core-Stability Exercises Alone in Mechanical low back pain (MLP)Methods: A 6 month pretest-posttest design, quasi experimental study was conducted at department of physiotherapy Khyber Teaching Hospital (KTH) Peshawar, Pakistan. We conveniently selected a sample 40 patients and placed into two groups. The SLM techniques with CS exercises was applied in group A and CS exercises alone in group B for 6 weeks. The Oswestry Disability Index (ODI) and Visual analog scale (VAS) for mechanical low back pain were assessment tools assessed for all patients before and after 6 weeks of physical therapy intervention. Data was analyzed by SPSS and statistical test were applied at 95% level of significance determine the efficacy of both the treatments regimes and compared with each other. Results: After comparison between two groups, the group A treated with specific lumber mobilization techniques shows better results in improving pain (p=0.008) and reducing physical disability (p=0.004) as compared to the group B treated with specific lumber mobilization techniques alone . Conclusion: It is concluded that patients with mechanical low back pain will show more improvement in pain and function while treated by specific lumber mobilization and core stability exercises as compared to those patients who will be treated by specific joint mobilization techniques.  The objective of the current study was to determine the combined effect of manual physical therapy and core stability exercise therapy in the management of mechanical low back pain. 8. The manual therapy is a commonly used management of mechanical low back pain to improve the mobility of the lumbar spine. These techniques are based on glides passively procured in prone position by manual physical therapists. The techniques used in this research study were central anterior-posterior glides, and unilateral anterior-posterior glides. The aim of specific lumber mobilization techniques is to improve pain and increase mobility 9.  Peshawar, Pakistan. We conveniently selected a sample 40 patients and placed into two groups. The SLM techniques with CS exercises was applied in group A and CS exercises alone in group B for 6 weeks. The Oswestry Disability Index (ODI) and Visual analog scale (VAS) for mechanical low back pain were assessment tools assessed for all patients before and after 6 weeks of physical therapy intervention. Data was analyzed by SPSS and statistical test were applied at 95% level of significance determine the efficacy of both the treatments regimes and compared with each other. All the 40 patients were treated for 6 weeks at 4 days per week, for single session of 45 minutes. The specific lumber mobilization techniques  were applied in prone lying position at 6-8 glides per session from T12 to L5 and followed by core stability exercises for local muscles  and global dynamic muscles  muscles. The physical activities for these core stability exercises are listed in The base line characteristics of all 40 patients were documented before the start of the study . All theThe mean pain intensity was 7/10 and disability score 38 on ODI (moderate disability) before intervention in group B, which was treated by specific lumber mobilization techniques alone improve pain intensity to 5/10 on VAS and disability score to 26 (moderate disability).After comparison between two groups, the group A treated with specific lumber mobilization techniques shows better results in improving pain (p=0.008) and reducing physical disability (p=0.004) as compared to the group B treated with specific lumber mobilization techniques alone . 10The result of this research study shows that the specific lumber mobilization techniques combined with core stabilization exercises are in the management of Mechanical low back pain can manage better manage pain and disability, as compared with lumber specific mobilization alone. Delitto and colleagues developed the clinical practice guidelines on low back pain under the orthopedic section of American Physical Therapy association. They recommended that the non-thrust mobilization improves pain, spinal mobility, and disability in both acute and chronic pain and pain related to lower extremity. These recommendations are based on strong evidence. 11Salven and team conducted a systematic literature review on the relative effectiveness of segmental specific level and non-specific level spinal joint mobilization on pain and range of motion. They found multiple studies which provide evidence that single session of joint mobilization can lead to reduction in pain at rest and with most painful movements. 12Aure and group conducted a randomized control trial to compare the effect of manual therapy with exercise therapy on 49 patients. They applied manual therapy on 27 and exercise therapy on 22 patients for the time course of 2 month. They concluded that the improvements in movement were more in manual therapy group as compare to the patient in the exercise therapy group. 13Sarigiovannis and associates carried out a review to assess the evidence for the effectiveness of cervical spine manipulation and mobilization in the treatment of non-specific neck pain. The total of 12 randomized control trials meets the criteria and achieved the methodological score range from 25-67 out of 100. The available evidence assessed for these 12 randomized control trials supports the effectiveness of spinal manual therapy in non- specific neck pain while applied in conjunction with exercise therapy. 14Xue-Qiang Wang and colleagues conducted a meta-analysis to review the effects of core stability exercise or general exercise for patients with chronic low back pain (LBP). They found 28 potentially relevant trials, which support the evidence for the effectiveness of core stability exercises as compare to the general exercises in patients with chronic low back pain. 15Cairns and team carried out a pragmatic, multicentered randomized controlled trial on 97 patients of low back pain with 12 months follow up. All patients were placed into two groups through stratified random sampling technique. The conventional physical therapy including general active exercise combined with manual therapy was applied in group A, while conventional physical therapy combined with core stability exercise therapy in group B. sixty eight patients out of 97 completed the study and on the basis of results obtained they concluded that both packages of treatment showed the same effects and the sign and symptoms were improved with same degree in both treatment groups. 16Valerie Gladwell and group conducted A single blind randomized controlled trial to evaluate the effect of a program of modiﬁed Pilates for active individuals with chronic non-speciﬁ c low back pain on 49 patients of low back pain. All the patients were randomly placed into two group and group A 24 patients was the Pilates group and active population group includes 25 patients. Total of 34 patients completed the study, 14 in group A and 20 in group B. they concluded that Pilates used as a speciﬁ c core stability exercise incorporating functional movements can improve non-speciﬁ chronic low back pain in an active population compared to no intervention.It is concluded that patients with mechanical low back pain will show more improvement in pain and function while treated by specific lumber mobilization and core stability exercises as compared to those patients who will be treated by specific joint mobilization techniques.Dr. Rafiq Ahmed and Dr. Syed Shakil-ur-Rehman conceived, designed and did statistical analysis & editing of manuscriptDr. Rafiq Ahmed, Dr. Syed Shakil-ur-Rehman, and Dr Fozia Sibtain did data collection and manuscript writing


P < 0.05. Statistical analysis showed a significant decrease in the time required to cover a 100-meter distance and a decrease in pain perception presented by significantly lower painkillers' intake in the test group in comparison with the control group. The improvement in clinical condition observed in the research indicates the efficiency of KT as a method complementing physiotherapy in patients after laparoscopic cholecystectomy.Physiotherapy in patients after laparoscopic cholecystectomy (CHL) is impeded by postoperative pain which causes a decline in patients' activity, reduces respiratory muscles' function, and affects patients' ability to look after themselves. The objective of this work was to assess the influence of Kinesio Taping (KT) on pain level and the increase in effort tolerance in patients after CHL. The research included 63 patients after CHL. Test group and control group included randomly selected volunteers. Control group consisted of 32 patients , test group consisted of 31 patients . Both groups were subjected to complex physiotherapy, and control group had additional KT applications. Before surgery, during and after physiotherapy, patients were given the following tests: 100-meter walk tests, subjective pain perception assessment, and pain relief medicines intake level assessment. The level of statistical significance for all tests was established at  Laparoscopic cholecystectomy (CHL) is a type of classic cholecystectomy. Both methods involve removing the gall-bladder containing gallstones. Most frequently, gall-bladder resection is caused by lithiasis or its complications –6. Bile ducts surgery is one of the key aspects of general surgery. Surgeries performed within bile ducts come first in terms of the number of carried out surgeries and exceed the number of hernia or appendix surgeries –6.Surgeries within abdominal cavity lead to body function disorders manifested in postoperative paralysis of alimentary canal motoricity. Pain is a significant problem occurring after surgeries –6.The aim of physiotherapy in surgery is to prevent postoperative complications and treatment of postoperative functional disorders. Kinesio Taping (KT), which might enhance the effects of rehabilitation, is one of the ways to support physiotherapy after surgeries. Over the last decade, the use of KT has become increasingly common. The tape use in KT demonstrates elasticity and thickness resembling human skin. Kase et al.  have proIn case of patients after laparoscopic cholecystectomy, physiotherapy is hindered by postoperative pain which limits patients' physical activity and impairs patients' ability to look after themselves. The process of healing of postoperative wound is also accompanied by pain resulting from immobilization after surgery.The aim of this work was to assess the influence of KT applications on the effects of physiotherapy in patients after CHL. KT is one of the ways of supporting physiotherapy after CHL because it might have a positive influence on the stabilization of postoperative wound and reduce pain.The study was approved by the Ethics Committee of Opole Voivodship (no. 150/2007).The research included 63 patients after CHL treated in General Surgery Department of Hospital in Nysa between April 2007 and August 2008 . To achiContrastive analysis of parameters recorded before surgery shows that patients from test and control groups did not differ in terms of the level of subjective pain perception, waist size, lung ventilation activity disorders, effort tolerance, and BMI. In both groups, complex physiotherapy was conducted according to standard physiotherapy program. In test group, additional KT applications were used. Scheduled CHL and age between 40–60 qualified patients for the research. Exclusion criteria included lack of patient's informed consent, age below 40 or above 60, respiratory and cardiac failure (NYHA class III-IV), below 40% of FEV1 predicted value, and postoperative complications .Before, during, and after physiotherapy, the following tests were given for all patients:subjective pain perception assessment ,100-metre walk test,pain relief medicines intake level.The assessment of pain intensity involved the patient determining the intensity of perceived pain against the VAS scale. It was assumed that 0 represents no pain, 5 represents strong pain perception, and 10 represents maximal pain intensity. The test of subjective pain perception was given one day before the surgery, 24 hours after the surgery as well as on the second, third, and eighth day after CHL.The test was carried out along a specially selected straight section of the hospital corridor, always at the same time in the morning. A 50-metre long distance was measured and marked with posts. The starting line was marked with coloured tape. The patient marched along the corridor, back and forth, at the highest possible pace to cover the distance of 100 metres. The patients were informed to adjust the pace of walking to the subjective feeling of tiredness. Running was not allowed during the test. Blood pressure and maximal effort pulse values were recorded. The test was terminated at the moment of the occurrence of intensified feeling of dyspnea or tiredness, increased abdominal area pain, paleness or growing blue, balance disorders, or chest pain . The tesPain relief medicines intake level was recorded 24 hours after the surgery and on the second, third, and eighth day after CHL.The following intake levels and medicine types were defined:level 0—the patient felt no pain and did not take painkillers (0 pts.),level I—Ketoprofen pain relief 100 mg ampoules were taken max. 3 times a day (1–3 pts.),level II—pain relief pump was used intravenously (4 pts.).In case of no pain perception, the patient did not take any painkilling tablets (level 0). Level I depended on the intensity of pain. Level II of medicines intake was applied when medicines from level I were insufficient and did not ensure patients comfort.The patients who participated in the research were not prescribed any additional medicines.After excluding contraindications, 24 hours after surgery, patients from the test group were given the following KT applications:muscle application—detoning, applied  on external abdominal oblique muscles on the left side;muscle application—detoning, applied on internal abdominal oblique muscles on the right side;fascial application on the liver area .Statistical analysis was conducted with the use of STATISTICA 7.1 program.The results were presented as arithmetic average and standard deviation values. Median, quartile, and extreme values were also established .Double classification variance analysis was carried out for dependent variables determining pain level. Depending on the significance of main effects and interactions, the contrastive analysis and the post hoc analysis were also used before and after surgery.U Test was used.In case of variables with asymmetrical distribution (skewed distribution) differing significantly from normal distribution, nonparametric rank-sum Mann-Whitney P < 0.05 for all tests.Multiple-regression analysis was used for dependent variable defining average medicine intake in particular tests. Statistical significance level was established at P) and on the 1st, 2nd, 3rd, and 8th day after CHL.The assessment of subjective pain perception on the VAS scale was carried out before the surgery (P) in case of patients from test and control groups did not differ significantly. The results recorded in consecutive tests showed significantly lower index values in the test group than in the control group. Statistically significant differences were observed between the results of tests carried out on the 1st, 2nd, 3rd and 8th day after CHL in both groups.Statistical analysis showed that the values of subjective pain perception indexes before the surgery , on the third and on the eighth day after the surgery.To assess patients' effort tolerance, 100-metre walk test time was recorded before the surgery  patients from the test group took painkilling tablets whereas all of 31 patients (100%) from the control group used pain relief medicines .Chi-square test analysis showed differences in pain relief medicines intake distribution between patients from the two research groups.So far, research showed the possibility of using KT in sports medicine and various other medical fields –29.Professional literature reports the possibility of employing KT in surgery. So far, it has proved useful in stabilizing postoperative wounds. There are, however, no reports related to complex physiotherapy treatment with the use of KT in general surgery, including laparoscopic cholecystectomy.Literature reports no studies analyzing the influence of KT on physiotherapy of patients after surgeries, especially in the area of its influence on the subjective pain perception, effort tolerance or pain relief medicines' intake.Own research confirms earlier assumption stating that KT is one of the methods which, not only have a positive influence on the stabilization of postoperative wounds, but also has a painkilling effect in case of patients after CHL. It is hypothetical what physiological mechanisms are responsible for the analgesic effects of KT. One possible theory to be taken into account is the gate control theory of pain modulation. The tape has been suggested to stimulate neuromuscular pathways via afferent feedback. Increased afferent stimulus to large-diameter nerve fibers might reduce pain perception level due to an input decrease from the small-diameter nerve fibers conducting nociception. Thelen et al.  refer toResearch results confirm the positive influence of KT on the decrease in pain perception resulting in a lower intake of painkilling tablets.KT applications employed in the physiotherapy process in patients after laparoscopic cholecystectomy had a significant influence on the decrease of pain perception level as well as an increase in effort tolerance and reduced the level of pain relief medicines' consumption in comparison with patients from the control group. It seems that KT, as a complement to complex physiotherapy, might contribute to faster regaining of independence in case of patients after CHL and improve their quality of life.It seems that KT creates the opportunities for effective support for physiotherapy. Providing postoperative wound stabilization, it allows for reduction of functional activity disorders resulting from surgery and might indirectly enhance the effects of physiotherapy within the short time of hospital treatment. Standard physiotherapy combined with KT might shorten hospitalization time for these patients. Because it significantly decreases painkilling medicines intake and shortens hospitalization time, it might contribute to the reduction of treatment costs of patients' surgeries.Research showed that Kinesio Taping employed in physiotherapy of patients after laparoscopic cholecystectomy leads to a decrease in pain perception and significantly reduces pain relief medicines' intake.Improvement in effort tolerance achieved in the research shows the efficiency of Kinesio Taping employed for physiotherapy of patients after laparoscopic cholecystectomy.Kinesio Taping provides effective support for physiotherapy and, through postoperative wound stabilization, reduces functional activity disorders resulting from CHL allowing for shortening of hospitalization time.


Low back pain is a common and costly condition. There are several treatment options for people suffering from back pain, but there are few data on how to improve patients' treatment choices. This study will test the effects of a decision support package (DSP), designed to help patients seeking care for back pain to make better, more informed choices about their treatment within a physiotherapy department. The package will be designed to assist both therapist and patient.Firstly, in collaboration with physiotherapists, patients and experts in the field of decision support and decision aids, we will develop the DSP. The work will include: a literature and evidence review; secondary analysis of existing qualitative data; exploration of patients' perspectives through focus groups and exploration of experts' perspectives using a nominal group technique and a Delphi study.Secondly, we will carry out a pilot single centre randomised controlled trial within NHS Coventry Community Physiotherapy. We will randomise physiotherapists to receive either training for the DSP or not. We will randomly allocate patients seeking treatment for non specific low back pain to either a physiotherapist trained in decision support or to receive usual care. Our primary outcome measure will be patient satisfaction with treatment at three month follow-up. We will also estimate the cost-effectiveness of the intervention, and assess the value of conducting further research.Informed shared decision-making should be an important part of any clinical consultation, particularly when there are several treatments, which potentially have moderate effects. The results of this pilot will help us determine the benefits of improving the decision-making process in clinical practice on patient satisfaction.ISRCTN46035546Current Controlled Trials  Low back pain (LBP) is a common, disabling and expensive disorder. In 1998 treating this condition cost the National Health Service (NHS) £1,632M .A patient-centred approach, using shared decision-making (SDM), involves the patient and healthcare professional discussing treatment options and interacting to agree on a management plan ,6. This Coaching to support patients' making decisions is effective in aiding patients' knowledge, information recall, and participation in decision-making . DecisioPatients report they would like to play an active role in decisions concerning their health . Many paThe aim of this pilot RCT is to develop and test the effect of a DSP on patient satisfaction. This package will comprise material to assist both the physiotherapist and patient during the informed shared decision-making process. Overall, the DSP will be designed to help patients seeking care for back pain, make informed choices, about their treatment which are the best for them.This pilot has been funded by the National Institute of Health Research - Research for Patient Benefit Programme (Ref: PB-PG-0808-17039). Ethical approval has been granted by Warwickshire Research Ethics Committee (Ref: 10/H1211/2).To inform the design of the DSP, we will conduct a series of exploratory studies (described in more detail below). This work will be carried out in collaboration with physiotherapists, patients, and experts in the field of decision support and decision aids. At this time it is difficult to predict the exact nature of the DSP - this will depend on the findings from our exploratory work. However, we anticipate that there will be: an information package that summarises the nature of each intervention; a rationale for the interventions, questions that assist the patient in reviewing their current health status and the value they place on possible future scenarios, and what is known about the effectiveness of the interventions.In a recent Cochrane review of decision aids for people facing health treatment or screening decisions, the included studies used a variety of decision aids for a range of conditions. A sample of some of the decision aids included were cancer treatments and screening, back surgery, hormone replacement therapy and osteoporosis treatments. The decision aids varied in formats including video tapes, computer based interactive programmes, audio material and information booklets . Some deIn the early phase, we will ask physiotherapists within the Coventry Community Physiotherapy team to test the intervention in an uncontrolled manner, allowing us to test practicality and feasibility in the clinical environment. We will assess this by direct observation of the consultation process and through focus groups with patients and physiotherapists. This will allow us to optimise the intervention before starting the pilot RCT.The section below describes the exploratory work to be undertaken to inform the intervention design.We will review relevant new trial data published since the 2009 National Institute for Health and Clinical Excellence (NICE) guidelines on low back pain . It is sWe will systematically seek studies of decision aids for treatments for benign disorders, such as tennis elbow or depression, with multiple moderately effective treatment options. We will extract data about the components of these interventions and the mechanisms by which they are thought to act. We will use this data to inform the design of our decision aid.We will also systematically identify qualitative studies of people with chronic back pain that include accounts of why they chose different therapies. This will provide us with some understanding of the reasoning behind treatment choice within patients with back pain.We have interview data from people living with back pain undertaken with individuals in both the intervention and control arm of a clinical trial evaluating a group cognitive behavioural approach for patients with low back pain in primary care  . InterviConcurrently we will develop a questionnaire to measure current patient preferences for treatment. We will approach around 100 people seeking treatment from the physiotherapy department for LBP. Those interested will be asked to complete the questionnaire and subsequently participate in a focus group. Interested respondents will provide a sampling frame for our focus groups. Our purposive sampling willbe informed by age, gender, duration & troublesomeness of LBP, treatment decisions and treatment preferences. We will run two focus groups to develop a broad understanding of the factors that inform choice and decision-making among patients with back pain in which we will explore: how patients make decisions in general (i.e. decision style), how they make decisions and choices about treatments for their back pain, what information patients would like to help them make more informed choices, and what patients think of the existing material on offer to them.Qualitative data will be analysed using the framework method to identify key concepts and themes .To develop an understanding of experts' views and experiences of informed shared decision-making for LBP treatments we have selected two broad areas of experts, physiotherapists and patient experts. By engaging these two groups we hope to generate a range of experiences which will feed into our intervention design.We will recruit physiotherapists, who regularly provide first contact care for low back pain from a neighbouring primary care trust, to a nominal group - a formal face to face consensus method . This isConcurrently, we will also conduct a Delphi study with patient group leaders, expert patients and advocacy group activists. We will work with local and national organisations to identify expert patients who have experience of managing back pain. We have selected the Delphi method as it is a practical method of obtaining opinions from a range of experts nationally. We will develop a set of questions to send to the experts; the responses will then be collated and fed back to the participants for further rounds of questions. Rounds will continue until consensus is achieved.The results of the reviews and secondary analyses together with the focus groups, nominal group technique and the Delphi study will feed into the intervention design. We will use the overall consensus of opinion to help inform how we develop, and what we include, in our decision support package. It is not possible at the time of writing to pre-judge the content and format of the decision support package. As part of the design process for the package we will invite comments from key opinion leaders in back pain research nationally and internationally to ensure that no key content has been omitted.This study is a single centre randomised controlled trial taking place in the physiotherapy service at NHS Coventry Community Physiotherapy. The physiotherapy service sees around 300 patients as new back pain referrals a month. The service uses a paper free referral system, when patients are advised by their GP to attend the physiotherapy service, it is the patient's responsibility to call the booking team and arrange an appointment.Physiotherapists will be randomised to either receiving training for the DSP or not. Subsequently patients will be randomised to either a trained or a standard physiotherapist.One hundred and fifty participants seeking treatment from the physiotherapy service at NHS Coventry Community Physiotherapy will be recruited. We will include patients who have been advised by their GP to attend physiotherapy. GPs are asked to refer those patients presenting with LBP who do not return to normal activities after 3-4 weeks. Earlier referrals can be made for patients who are not coping with their pain e.g. the pain has a significant effect upon daily living or they present with poor prognosis which the GP is unable to address. In all cases the GP would provide patients with the Back Pain Access number. The patient is then free to ring and directly book a 45 minute assessment appointment. GPs are asked to exclude patients if they have signs of red flags, acute LBP of less than 3-4 weeks, those already under secondary care, had recent lumbar spine surgery, LBP as part of a presentation of multiple body pains e.g. fibromyalgia, thoracic or cervical pain and unstable psychiatric illness.In this pilot RCT patients will be included if they are seeking treatment for non specific LBP, they are aged ≥18 years and have fluent spoken and written English. We will exclude patients with severe psychiatric or personality disorders, those with a terminal or critical illness and patients with possible serious spinal pathology .Following advice from their GP, the patient is given information on how to get in touch with the booking service to make an appointment  physiotherapists to deliver the intervention. Patients will then be randomised to physiotherapists. Once the consent form and baseline questionnaire are received, the physiotherapy department will call the Warwick Clinical Trials Unit randomisation service to randomise the patient to either the control or intervention arm. Clinic lists will be adjusted to ensure participants have appointments with the allocated therapists: control or intervention.Our package of outcome measures is based on those we have used successfully in two previous large scale community based trials of LBP treatments and are in line with international recommendations ,27.We will use satisfaction with treatment at three months using a five-point Likert Scale (very satisfied to very dissatisfied) as our primary outcome. It is an amended version of the standardised and recommended single-item question . Since a• Roland Morris Disability Questionnaire (RMDQ)  - The mo• Modified Von Korff  - A meas• SF-12  - A gene• EuroQol  - A gene• Hospital Anxiety and Depression Scale (HADS)  - An est• Pain Self-Efficacy Questionnaire (PSEQ)  - An est• Fear Avoidance Beliefs Questionnaire (FABQ)  - The ph• Attendance - we will measure attendance from the physiotherapy department's records.• Use of health services and costsThe immediate follow-up assessment will focus on satisfaction with the decision-making process. We will use the 'Satisfaction with Decision Scale' . This isFor this pilot RCT we will do a single follow-up after three months, when treatment will be complete and maximum benefit from treatment is expected. In addition to measuring satisfaction and repeating baseline measures we will collect data on health service use and health transition . We willIn the Back Skills Training (BeST) trial, satisfaction with treatment was measured using a five-point Likert Scale (very satisfied to very dissatisfied) . In thisDescriptive summary statistics for demographic and baseline data will be provided. The dichotomised responses on the five point Likert scale to the treatment satisfaction question will be analysed by means of a generalised linear mixed model with logit link, fixed effects for intervention and baseline pain severity, and random physiotherapist effects. The estimated intervention effect (odds ratio) will be reported with 95% confidence interval and p-value testing the null hypothesis of no intervention effect. Continuous outcomes will be reported as difference in change from baseline with its 95% confidence interval.We will estimate the mean cost of the intervention and other back pain-related NHS services and participants' out of pocket expenses over the three-month study period. We will collect information on the cost of training for the physiotherapists in the DSP group, including the cost of the tutors' time to prepare and deliver the training, the cost of participants' time, travel costs and materials.Therapy cost will be collected from PCT records. The three-month follow-up questionnaire will include questions about use of medication (prescribed and over-the-counter), GP attendances, inpatient stays, outpatient consultations, and visits to other therapists (NHS and private). Healthcare cost will be estimated using unit costs from the NHS tariff and standard references texts .The 'within-trial' difference in mean costs and the difference in mean quality adjusted life years (QALYs) will be estimated with 95% confidence intervals, allowing for the effects of treatment, baseline pain severity, and treating physiotherapist. These estimates will help us to assess the potential benefits of conducting a definitive trial and economic evaluation. For example, if the DSP is associated with greater healthcare costs and no apparent improvement in health outcomes over this initial three-month period, it is unlikely that further research would be worthwhile, particularly if there is also no clear evidence of a strong patient preference for use of the DSP. However, if cost savings and/or health improvements are observed, it is possible that DSP may be a cost-effective intervention and further research would be warranted.Martin Underwood was chair of the guideline development group for the NICE Low back pain guidelines. Joanne Lord was employed by NICE at the time of the development of the NICE Low Back Pain Guidelines and advised the guideline development group on economic analysis. All other authors declare that they have no competing interests.All authors have read and approved the final manuscript.SB - has contributed to the design of the study and has commented on draft versions of this manuscript. TF - has contributed to the design of the study and is overseeing the quantitative analyses. TF has commented on draft versions of this manuscript. FG - has contributed to the design of the study and is overseeing the qualitative analyses. FG has commented on draft versions of this manuscript. JL - has contributed to the design of the study and is overseeing the economic analysis. AN - has commented on draft versions of this manuscript. SP - has substantially contributed to the conception and design of the study. SP has drafted this manuscript. CT - has contributed to the design of the study and has commented on draft versions of this manuscript. JT - has contributed to the design of the study and is overseeing the intervention design. JT has commented on draft versions of this manuscript. MW - has contributed to the design of the study. MU - is the principal investigator. He has substantially contributed to the conception and design of the study and obtaining the funding. MU has critically commented on draft versions of the manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/12/52/prepub


Aural microsuction is a common ear, nose and throat procedure used in the outpatient setting. Some patients, however, find it difficult to tolerate owing to discomfort, pain or noise. This study evaluated the effect of audiovisual distraction on patients’ pain perception and overall satisfaction.A prospective study was conducted for patients attending our aural care clinic requiring aural toileting of bilateral mastoid cavities over a three-month period. All microsuction was performed by a single clinical nurse specialist. Any patients with active infection were excluded. For each patient, during microsuction of one ear, they watched the procedure on a television screen while for the other ear they did not view the procedure. All patients received the same real time explanations during microsuction of both ears. After the procedure, each patient completed a visual analogue scale (VAS) to rate the pain they experienced for each ear, with and without access to the television screen. They also documented their preference and reasons why.p=0.003), consistent with the majority of patients reporting a preference to viewing their procedure (65%).A total of 37 patients were included in the study. The mean pain score for patients viewing the procedure was 2.43 compared with a mean of 3.48 for patients with no television view. This difference in patients’ pain perception was statistically lower in the group who observed the procedure on the television (Audiovisual distraction significantly lowered patients’ VAS pain scores during aural microsuction. This simple intervention can therefore reduce patients’ perceived pain and help improve acceptance of this procedure. Aural microsuction is one of the most common procedures performed in daily ear, nose and throat (ENT) practice in the outpatient setting. It is used regularly for dewaxing in patients who may have narrow ear canals or large, open mastoid cavities as well as for clearing debris or mucous in infective cases. However, for a considerable number of patients, it can provoke significant anxiety and distress, owing to discomfort and pain as well as the significant noise that it produces.A variety of different interventions and techniques have been described for some other minimally invasive procedures, with the aim of trying to distract patients and thereby reduce their pain and distress, with variable results. For example, music has been shown to be effective in serving as a useful distraction strategy during colposcopy, significantly reducing patients’ anxiety and pain.Audiovisual (AV) distraction, where patients are allowed to view their procedures on a television screen, has also been studied as a distraction technique. AV distraction during colonoscopy has been shown to significantly reduce patients’ pain scores.We sought to evaluate the effect of AV distraction on pain perception for patients undergoing aural microsuction. To our knowledge, this is the first study of its kind to evaluate this for an ENT-based procedure.A prospective, controlled study was conducted to evaluate the effect of AV distraction on patients’ pain scores after undergoing aural microsuction. Patients attending our nurse-led aural care clinic between November 2011 and February 2012 were considered for the study. Only patients with bilateral mastoid cavities, requiring aural microsuction of both cavities, were included, with each patient thereby serving as their own internal control. Any patients with signs of active inflammation or infection in either cavity were excluded so as to avoid the potential for this affecting their pain scores.All microsuction was performed by a single clinical nurse specialist. Each patient was able to view the microsuction of the left ear on a television screen but was not allowed to view the procedure while microsuction of the right ear was being performed. All patients received the same real time explanations during the procedure for both ears. After the microsuction, patients were asked to complete a simple questionnaire including a ten-point visual analogue scale (VAS) to rate the level of pain experienced during microsuction of each ear in turn. Patients were also asked to document whether they preferred to have microsuction performed with or without the television screen and their reasons why. All data were collected anonymously and statistical analysis was performed using the Mann–Whitney test.p=0.003) . The mean pain score on the VAS for patients viewing their aural microsuction procedure was 2.432 (standard deviation [SD]: 0.203), with a range of 0–5. This compared with a mean pain score of 3.486 (SD: 0.273) for the same patients who did not view their procedure, with a range of 1–6. This difference in average pain scores was analysed using the non-parametric Mann–Whitney test and was found to be statistically significant (p=0.003) .Patients were also asked to comment on whether they had a preference for watching their procedure on a television screen. A majority of 24 patients (65%) documented that they preferred to view their microsuction procedure. Only nine patients (24%) stated they preferred not to observe their procedure and four patients (11%) said they did not have a preference. Of those patients who preferred to view their procedure, the common reasons cited for this included that the television screen helped to distract them, made the procedure less painful and more relaxing. Some also said they found it interesting to observe what was being done and found it helpful to supplement their understanding of the procedure.There have been a number of studies evaluating the use of different distraction techniques to aid pain management for a variety of minimally invasive procedures. The concept of using ‘distraction’ to reduce pain perception is thought to be related to the central cognitive processing requirement that is needed for the distraction task. McCaul and Malott postulated a ‘capacity model for attention and pain’.There is little known regarding the specific characteristics of individual distraction tasks and which will be optimal in pain management outcomes. Nevertheless, as pain processing is a central resource, it is considered that the distraction task must also engage central cognitive resources, in order to provide redirection of attention.We sought to evaluate the effect of AV distraction on patients’ pain perception during aural microsuction. Patients commonly find this routine outpatient procedure uncomfortable, distressing and painful, largely owing to the loud noise that it generates close to their ears, which are inherently a highly sensitive organ. The results of our study have shown a significant reduction in the pain experienced by patients when able to view their microsuction on a television screen, in keeping with a clear majority of patients stating that they preferred to view their procedure. Patients reported to prefer this distraction technique as it made them feel more involved, distracted them from the physical aspects of microsuction and improved their understanding of the procedure, thereby making it more acceptable. AV distraction may therefore provide a simple tool to help improve patients’ experience and acceptance of this procedure.