Peripheral nerve stimulation compared with usual care for pain relief of hemiplegic shoulder pain: a randomized controlled trial.
ABSTRACT: This study sought to establish the efficacy of single-lead, 3-wk peripheral nerve stimulation (PNS) therapy for pain reduction in stroke survivors with chronic hemiplegic shoulder pain.This study is a single-site, pilot, randomized controlled trial of adults with chronic shoulder pain after stroke. Participants were randomized to receive a 3-wk treatment of single-lead PNS or usual care. The primary outcome was the worst pain in the last week (Brief Pain Inventory, Short Form, question 3) measured at baseline and weeks 1, 4, 12, and 16. The secondary outcomes included pain interference (Brief Pain Inventory, Short Form, question 9), pain measured by the ShoulderQ Visual Graphic Rating Scales, and health-related quality-of-life (Short-Form 36 version 2).Twenty-five participants were recruited, 13 to PNS and 12 to usual care. There was a significantly greater reduction in pain for the PNS group compared with the controls, with significant differences at 6 and 12 wks after treatment. Both PNS and usual care were associated with significant improvements in pain interference and physical health-related quality-of-life.Short-term PNS is a safe and efficacious treatment of shoulder pain. Pain reduction is greater compared with usual care and is maintained for at least 12 wks after treatment.
Project description:<h4>Introduction</h4>Previous systematic reviews have identified the multiple factors impacting on the prognosis of shoulder pain. However, the typical clinical course of subacromial shoulder pain remains unclear. The aim of this systematic review is to assess the clinical course of pain and disability in patients with subacromial shoulder pain.<h4>Method and analysis</h4>We will systematically search electronic databases (Medline, Embase and AMED (via Ovid), Web of Science, Cochrane Library and Scopus) from the date of inception to 28 February 2018 for randomised controlled trials (RCTs) and observational studies with patients with subacromial shoulder pain. We will follow patient groups measured with pain and disabilities with no intervention or usual care treatment. Two reviewers will extract the data, and assess the risk of bias within included studies. We will use the Cochrane Risk of Bias tool for RCTs, and a methodological quality assessment tool for observational studies. We will perform meta-analyses for changes in pain and disability scores for each group (usual care and no intervention) at different time categories (up to 6 weeks, 6-12 weeks, 12-26 weeks or more). If there are 10 or more studies, we will perform a meta-regression for each planned analysis. The outcomes of the included studies will be described individually if the above statistical methods are not possible. Findings from this review will be of interest to clinicians and researchers, and will describe the expected clinical course of subacromial shoulder pain. This study may indicate the potential differences between the clinical courses of pain and disability over time.<h4>Ethics and dissemination</h4>This review will not gather original data, hence ethical approval is not required. The results of this systematic review will be published in a peer-reviewed journal and presented at a scientific conference.<h4>Prospero registration number</h4>CRD42016052518.
Project description:To establish the effects on shoulder biomechanics from a peripheral nerve stimulation (PNS) treatment compared to physical therapy (PT) in stroke survivors with chronic hemiplegic shoulder pain.Single-site, pilot, randomized controlled trial for adults with chronic shoulder pain after stroke. Participants were randomized to receive a 3-week treatment of single-lead PNS or physical therapy (PT). The outcomes included isometric shoulder abduction strength, pain-free shoulder external rotation range of motion (ROM), delay in initiation and termination of shoulder abduction electromyogram (EMG) activity, and the Fugl-Meyer Motor Assessment (upper extremity section). Outcomes were measured at baseline, and at weeks 1, 4, 12, and 16.Twenty-five participants were recruited, 13 to PNS and 12 to PT. There were significant improvements for both PNS and PT in maximum isometric shoulder abduction strength, pain-free external rotation ROM, and Fugl-Meyer Motor Assessment. There were no significant changes in delay of initiation or termination of deltoid EMG with either treatment.Both PNS and PT are capable of improving shoulder biomechanics in those with HSP, though changes in biomechanics alone do not account for the greater pain relief associated with PNS than PT.
Project description:Subacromial pain syndrome (SAPS) is a prevalent condition that results in loss of function. Surgery is indicated when pain and functional limitations persist after conservative measures, with scarce evidence about the most-appropriate post-operative approach. Interferential therapy (IFT), as a supplement to other interventions, has shown to relieve musculoskeletal pain. The study aim was to investigate the effects of adding IFT electro-massage to usual care after surgery in adults with SAPS. A randomized, single-blinded, controlled trial was carried out. Fifty-six adults with SAPS, who underwent acromioplasty in the previous 12 weeks, were equally distributed into an IFT electro-massage group or a control group. All participants underwent a two-week intervention (three times per week). The control group received usual care (thermotherapy, therapeutic exercise, manual therapy, and ultrasound). For participants in the IFT electro-massage group, a 15-min IFT electro-massage was added to usual care in every session. Shoulder pain intensity was assessed with a 100-mm visual analogue scale. Secondary measures included upper limb functionality (Constant-Murley score), and pain-free passive range of movement. A blinded evaluator collected outcomes at baseline and after the last treatment session. The ANOVA revealed a significant group effect, for those who received IFT electro-massage, for improvements in pain intensity, upper limb function, and shoulder flexion, abduction, internal and external rotation (all, p < 0.01). There were no between-group differences for shoulder extension (p = 0.531) and adduction (p = 0.340). Adding IFT electro-massage to usual care, including manual therapy and exercises, revealed greater positive effects on pain, upper limb function, and mobility in adults with SAPS after acromioplasty.
Project description:Arthralgia occurs in up to 50% of breast cancer survivors treated with aromatase inhibitors (AIs) and is the most common reason for poor AI adherence. We conducted, in 121 breast cancer survivors receiving an AI and reporting arthralgia, a yearlong randomized trial of the impact of exercise versus usual care on arthralgia severity.Eligibility criteria included receiving an AI for at least 6 months, reporting ? 3 of 10 for worst joint pain on the Brief Pain Inventory (BPI), and reporting < 90 minutes per week of aerobic exercise and no strength training. Participants were randomly assigned to exercise (150 minutes per week of aerobic exercise and supervised strength training twice per week) or usual care. The BPI, Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, and Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire were completed at baseline and at 3, 6, 9, and 12 months. Intervention effects were evaluated using mixed-model repeated measures analysis, with change at 12 months as the primary end point.Over 12 months, women randomly assigned to exercise (n = 61) attended 70% (± standard deviation [SD], 28%) of resistance training sessions and increased their exercise by 159 (± SD, 136) minutes per week. Worst joint pain scores decreased by 1.6 points (29%) at 12 months among women randomly assigned to exercise versus a 0.2-point increase (3%) among those receiving usual care (n = 60; P < .001). Pain severity and interference, as well as DASH and WOMAC pain scores, also decreased significantly at 12 months in women randomly assigned to exercise, compared with increases for those receiving usual care (all P < .001).Exercise led to improvement in AI-induced arthralgia in previously inactive breast cancer survivors.
Project description:Pain and depression are the most common physical and psychological symptoms in primary care, respectively. Moreover, they co-occur 30% to 50% of the time and have adverse effects on quality of life, disability, and health care costs.To determine if a combined pharmacological and behavioral intervention improves both depression and pain in primary care patients with musculoskeletal pain and comorbid depression.Randomized controlled trial (Stepped Care for Affective Disorders and Musculoskeletal Pain [SCAMP]) conducted at 6 community-based clinics and 5 Veterans Affairs general medicine clinics in Indianapolis, Indiana. Recruitment occurred from January 2005 to June 2007 and follow-up concluded in June 2008. The 250 patients had low back, hip, or knee pain for 3 months or longer and at least moderate depression severity (Patient Health Questionnaire 9 score > or = 10).Patients were randomly assigned to the intervention (n = 123) or to usual care (n = 127). The intervention consisted of 12 weeks of optimized antidepressant therapy (step 1) followed by 6 sessions of a pain self-management program over 12 weeks (step 2), and a continuation phase of therapy for 6 months (step 3).Depression (20-item Hopkins Symptom Checklist), pain severity and interference (Brief Pain Inventory), and global improvement in pain at 12 months.At 12 months, 46 of the 123 intervention patients (37.4%) had a 50% or greater reduction in depression severity from baseline compared with 21 of 127 usual care patients (16.5%) (relative risk [RR], 2.3; 95% confidence interval [CI], 1.5-3.2), corresponding to a much lower number of patients with major depression (50 [40.7%] vs 87 [68.5%], respectively; RR, 0.6 [95% CI, 0.4-0.8]). Also, a clinically significant (> or = 30%) reduction in pain was much more likely in intervention patients (51 intervention patients [41.5%] vs 22 usual care patients [17.3%]; RR, 2.4 [95% CI, 1.6-3.2]), as was global improvement in pain (58 [47.2%] vs 16 [12.6%], respectively; RR, 3.7 [95% CI, 2.3-6.1]). More intervention patients also experienced benefits in terms of the primary outcome, which was a combined improvement in both depression and pain (32 intervention patients [26.0%] vs 10 usual care patients [7.9%]; RR, 3.3 [95% CI, 1.8-5.4]).Optimized antidepressant therapy followed by a pain self-management program resulted in substantial improvement in depression as well as moderate reductions in pain severity and disability.clinicaltrials.gov Identifier: NCT00118430.
Project description:Pain and depression are 2 of the most prevalent and treatable cancer-related symptoms, yet they frequently go unrecognized, undertreated, or both.To determine whether centralized telephone-based care management coupled with automated symptom monitoring can improve depression and pain in patients with cancer.Randomized controlled trial conducted in 16 community-based urban and rural oncology practices involved in the Indiana Cancer Pain and Depression (INCPAD) trial. Recruitment occurred from March 2006 through August 2008 and follow-up concluded in August 2009. The participating patients had depression (Patient Health Questionnaire-9 score > or = 10), cancer-related pain (Brief Pain Inventory [BPI] worst pain score > or = 6), or both.The 202 patients randomly assigned to receive the intervention and 203 to receive usual care were stratified by symptom type. Patients in the intervention group received centralized telecare management by a nurse-physician specialist team coupled with automated home-based symptom monitoring by interactive voice recording or Internet.Blinded assessment at baseline and at months 1, 3, 6, and 12 for depression (20-item Hopkins Symptom Checklist [HSCL-20]) and pain (BPI) severity.Of the 405 participants enrolled in the study, 131 had depression only, 96 had pain only, and 178 had both depression and pain. Of the 274 patients with pain, 137 patients in the intervention group had greater improvements in BPI pain severity over the 12 months of the trial whether measured as a continuous severity score or as a categorical pain responder (> or = 30% decrease in BPI) than the 137 patients in the usual-care group (P < .001 for both). Similarly, of the 309 patients with depression, the 154 patients in the intervention group had greater improvements in HSCL-20 depression severity over the 12 months of the trial whether measured as a continuous severity score or as a categorical depression responder (> or = 50% decrease in HSCL) than the 155 patients in the usual care group (P < .001 for both). The standardized effect size for between-group differences at 3 and 12 months was 0.67 (95% confidence interval [CI], 0.33-1.02) and 0.39 (95% CI, 0.01-0.77) for pain, and 0.42 (95% CI, 0.16-0.69) and 0.41 (95% CI, 0.08-0.72) for depression.Centralized telecare management coupled with automated symptom monitoring resulted in improved pain and depression outcomes in cancer patients receiving care in geographically dispersed urban and rural oncology practices.clinicaltrials.gov Identifier: NCT00313573.
Project description:To identify novel combinations of genetic and psychological factors that predicted 12-month postoperative pain and disability outcomes following arthroscopic shoulder surgery.A prospective presurgical cohort (n?=?150) was recruited to complete validated psychological questionnaires and have their DNA collected from saliva. DNA was genotyped for a priori selected genes involved with pain modulation (ADRB2, OPRM1, AVPR1A, GCH1, and KCNS1) and inflammation (IL1B, TNF/LTA, and IL6). The outcome measures of interest were the Brief Pain Inventory and Disabilities of the Arm, Shoulder, and Hand questionnaire. Followup for the cohort was at 3, 6, and 12 months postoperatively. After controlling for age, sex, race, and preoperative status, genetic and psychological factors were entered as main effects and interaction terms in separate general linear models for predicting postoperative pain and disability outcomes.Seven interactions involving pain-modulatory genes were identified. Three provided strong statistical evidence for different outcomes, including KCNS1 and kinesiophobia for preoperative pain intensity, ADRB2 and depressive symptoms for postoperative course, and GCH1 and anxiety symptoms for 12-month pain-intensity outcome. Ten interactions involving inflammatory genes were identified. Three provided strong statistical evidence for the 12-month postoperative course outcome, including 2 different IL6 single-nucleotide polymorphism and pain catastrophizing, and IL6 and depressive symptoms.The current study identified novel genetic and psychological interactions that can be used in future studies to further understand the development of persistent postoperative pain and investigate the effectiveness of tailored treatment.
Project description:INTRODUCTION:Lifetime prevalence of shoulder pain is 70%, and approximately 50% of people with shoulder pain will experience pain for more than a year. Rotator cuff-related shoulder pain (RCRSP) is the most common shoulder condition and the main non-surgical intervention is exercise therapy. For approximately 30% of people with RCRSP, this approach does not lead to a significant reduction in symptoms. This may be due to an inappropriate dosage or choice of exercises. The aim of this investigation is to compare the short, mid and long-term effects, in terms of symptoms, functional limitations, kinesiophobia and pain catastrophising, of three different shoulder rehabilitation approaches (education, strengthening, motor control) in adults with RCRSP. METHODS AND ANALYSIS:In this single-blind (assessor), parallel-group, randomised clinical trial, 123 adults presenting with RCRSP will take part in a 12-week rehabilitation programme. They will be randomly assigned to one of three groups (education only, strengthening approach or motor control-focused approach). Abbreviated version of the Disabilities of the Arm, Shoulder and Hand Questionnaire, the primary outcome, Western Ontario Rotator Cuff Index and Brief Pain Inventory will evaluate symptoms and functional limitations, while Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale will evaluate pain-related fear and catastrophising at baseline and at 3, 6, 12 and 24 weeks. Ultrasonographic acromiohumeral distances and tendon thickness will be assessed at baseline and 12 weeks. Intervention groups will be compared on outcomes with intention-to-treat analyses using two-way repeated measures analysis of variance if the data are normally distributed or non-parametric analysis of longitudinal data if they are not. ETHICS AND DISSEMINATION:Ethics approval was obtained from the Sectorial Rehabilitation and Social Integration Research Ethics Committee of the Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale Nationale (CIUSSS-CN). Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations. TRIAL REGISTRATION NUMBER:NCT03892603; pre-results.
Project description:BACKGROUND:Laparoscopic surgery has become a standard of care for many gynecological surgeries due to its lower morbidity, pain and cost compared to open techniques. Unfortunately, the use of carbon dioxide (CO2) to insufflate the abdomen is the main contributor to post-operative shoulder pain. METHODS:We aim to assess the effect of postoperative Trendelenburg position on shoulder pain after gynecological laparoscopic procedures. We hypothesize that maintaining the patient in Trendelenburg for 24?h postoperatively will significantly decrease postoperative shoulder pain and analgesic consumption. After obtaining written informed consent, 108 patients were prospectively randomized into two groups. In the control group, patients underwent standard gynecologic laparoscopic procedures; then after passive deflation of the pneumoperitoneum at the end of the surgery, the patients were placed in supine head up position in the post anesthesia care unit (PACU) and received our institution's common postoperative care. Patients in the intervention group were subjected to the same maneuver but were positioned in a Trendelenburg position (20 °) once fully awake and cooperative in the PACU and retained this position for the first 24?h. Numerical rating scale (NRS) was used to assess shoulder pain and nausea upon patient arrival to the PACU, at 4, 6, 12 (primary outcome) and 24?h postoperatively. Time to first rescue pain medication, total rescue pain medications and overall satisfaction with pain control were recorded. 101 patients were included in the final data analysis. RESULTS:Both groups were comparable in terms of baseline characteristics. NRS pain scores were significantly lower in the intervention group at 12?h compared to the control group (0 [0-1] versus 5 [1-4], p?<?0.001), furthermore improvement in postoperative shoulder pain between time of arrival to PACU (time zero) and 12?h postoperatively was significantly higher in patients allocated to the experimental group compared to the control group. Pain scores were significantly lower in patients allocated to the experimental group versus the control group (0 [0-1] versus 5 [1-4], p?<?0.001). CONCLUSION:In conclusion, Trendelenburg position is an easy non-pharmacologic intervention that is beneficial in reducing postoperative shoulder pain following gynecologic laparoscopic surgery. TRIAL REGISTRATION:Retrospectively registered at Clinicaltrials.gov, registration number NCT04129385, date of registration: June 28, 2019.
Project description:<h4>Background</h4>Percutaneous peripheral nerve stimulation (PNS) is an analgesic modality involving the insertion of a lead through an introducer needle followed by the delivery of electric current after needle withdrawal. This modality has been used extensively to treat chronic pain, but only small series have been published involving postoperative pain. The ultimate objective of this study is to determine the postoperative effects of percutaneous PNS following moderately to severely painful ambulatory surgery within a real-world clinical practice setting. The primary hypothesis is that surgical pain and opioid consumption during the initial 7 days after surgery will be reduced by percutaneous PNS compared with usual and customary analgesia (dual primary outcome measures).<h4>Design</h4>A multicenter pragmatic effectiveness trial. We are randomizing participants having painful orthopedic surgical procedures of the upper and lower extremity to receive 14 days of either 1) electrical stimulation or 2) sham in a double-masked fashion. End points are being assessed at various time points over 12 postoperative months.<h4>Summary</h4>The postoperative experience will be much improved if percutaneous PNS provides potent analgesia while concurrently decreasing opioid requirements following painful surgery. Because this modality can be administered for up to 60 days at home, it may provide postoperative analgesia that outlasts surgical pain yet has relatively few risks and, unlike opioids, has no systemic side effects or potential for abuse, addiction, and overdose. Percutaneous PNS has the potential to revolutionize postoperative analgesia as it has been practiced for the past century. This study will inform key stakeholders regarding an evidence-based nonpharmacologic approach to the management of postoperative pain.