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A manual physical therapy approach versus subacromial corticosteroid injection for treatment of shoulder impingement syndrome: a protocol for a randomised clinical trial.

ABSTRACT: Corticosteroid injections (CSI) are a recommended and often-used first-line intervention for shoulder impingement syndrome (SIS) in primary care and orthopaedic settings. Manual physical therapy (MPT) offers a non-invasive approach with negligible risk for managing SIS. There is limited evidence to suggest significant long-term improvements in pain, strength and disability with the use of MPT, and there are conflicting reports from systematic reviews that question the long-term efficacy of CSI. Specifically, the primary objective is to compare the effect of CSI and MPT on pain and disability in subjects with SIS at 12 months.This pragmatic randomised clinical trial will be a mixed-model 2×5 factorial design. The independent variables are treatment (MPT and CSI) and time with five levels from baseline to 1 year. The primary dependent variable is the Shoulder Pain and Disability Index, and the secondary outcome measures are the Global Rating of Change and the Numeric Pain Rating Scale. For each ANOVA, the hypothesis of interest will be the two-way group-by-time interaction.The authors plan to recruit 104 participants meeting established impingement criteria. Following examination and enrollment, eligible participants will be randomly allocated to receive a pragmatic approach of either CSI or MPT. The MPT intervention will consist of six sessions, and the CSI intervention will consist of one to three sessions. All subjects will continue to receive usual care. Subjects will be followed for 12 months.The protocol was approved by the Madigan Army Medical Center Institutional Review Board. The results may have an impact on clinical practice guidelines. This study was funded in part by the Orthopaedic Physical Therapy Products Grant through the American Academy of Orthopaedic Manual Physical Therapists. Trial Registration http://clinicaltrials.gov/ NCT01190891.

SUBMITTER: Rhon DI

PROVIDER: S-EPMC3191586 | biostudies-literature | 2011 Jan

REPOSITORIES: biostudies-literature

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A manual physical therapy approach versus subacromial corticosteroid injection for treatment of shoulder impingement syndrome: a protocol for a randomised clinical trial.

Rhon Daniel I DI Boyles Robert E RE Cleland Joshua A JA Brown David L DL

BMJ open 20110101 2

<h4>Introduction</h4>Corticosteroid injections (CSI) are a recommended and often-used first-line intervention for shoulder impingement syndrome (SIS) in primary care and orthopaedic settings. Manual physical therapy (MPT) offers a non-invasive approach with negligible risk for managing SIS. There is limited evidence to suggest significant long-term improvements in pain, strength and disability with the use of MPT, and there are conflicting reports from systematic reviews that question the long-t ...[more]

PMID: 22021870

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Project description:OBJECTIVE:To assess the efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy, a placebo surgical intervention, and with a non-operative alternative, exercise therapy, in a more pragmatic setting. DESIGN:Multicentre, three group, randomised, double blind, sham controlled trial. SETTING:Orthopaedic departments at three public hospitals in Finland. PARTICIPANTS:210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015. INTERVENTIONS:ASD, diagnostic arthroscopy (placebo control), and exercise therapy. MAIN OUTCOME MEASURES:Shoulder pain at rest and on arm activity (visual analogue scale (VAS) from 0 to 100, with 0 denoting no pain), at 24 months. The threshold for minimal clinically important difference was set at 15. RESULTS:In the primary intention to treat analysis (ASD versus diagnostic arthroscopy), no clinically relevant between group differences were seen in the two primary outcomes at 24 months (mean change for ASD 36.0 at rest and 55.4 on activity; for diagnostic arthroscopy 31.4 at rest and 47.5 on activity). The observed mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -4.6 (95% confidence interval -11.3 to 2.1) points (P=0.18) at rest and -9.0 (-18.1 to 0.2) points (P=0.054) on arm activity. No between group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse events. In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD in the two primary outcomes at 24 months in both VAS at rest (-7.5, -14.0 to -1.0, points; P=0.023) and VAS on arm activity (-12.0, -20.9 to -3.2, points; P=0.008), but the mean differences between groups did not exceed the pre-specified minimal clinically important difference. Of note, this ASD versus exercise therapy comparison is not only confounded by lack of blinding but also likely to be biased in favour of ASD owing to the selective removal of patients with likely poor outcome from the ASD group, without comparable exclusions from the exercise therapy group. CONCLUSIONS:In this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months. TRIAL REGISTRATION:Clinicaltrials.gov NCT00428870.

Project description:IntroductionArthroscopic subacromial decompression (ASD) is the most commonly performed surgical intervention for shoulder pain, yet evidence on its efficacy is limited. The rationale for the surgery rests on the tenet that symptom relief is achieved through decompression of the rotator cuff tendon passage. The primary objective of this superiority trial is to compare the efficacy of ASD versus diagnostic arthroscopy (DA) in patients with shoulder impingement syndrome (SIS), where DA differs only by the lack of subacromial decompression. A third group of supervised progressive exercise therapy (ET) will allow for pragmatic assessment of the relative benefits of surgical versus non-operative treatment strategies.Methods and analysisFinnish Subacromial Impingement Arthroscopy Controlled Trial is an ongoing multicentre, three-group randomised controlled study. We performed two-fold concealed allocation, first by randomising patients to surgical (ASD or DA) or conservative (ET) treatment in 2:1 ratio and then those allocated to surgery further to ASD or DA in 1:1 ratio. Our two primary outcomes are pain at rest and at arm activity, assessed using visual analogue scale (VAS). We will quantify the treatment effect as the difference between the groups in the change in the VAS scales with the associated 95% CI at 24 months. Our secondary outcomes are functional assessment (Constant score and Simple shoulder test), quality of life (15D and SF-36), patient satisfaction, proportions of responders and non-responders, reoperations/treatment conversions, all at 2 years post-randomisation, as well as adverse effects and complications. We recruited a total of 210 patients from three tertiary referral centres. We will conduct the primary analysis on the intention-to-treat basis.Ethics and disseminationThe study was approved by the Institutional Review Board of the Pirkanmaa Hospital District and duly registered at ClinicalTrials.gov. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations.Trial registration numberNCT00428870; Pre-results.

Project description:ObjectivesThe aim of this study was to assess whether it was feasible to conduct a full trial comparing a tailored versus a standardised exercise programme for patients with shoulder subacromial pain.DesignTwo-arm, patient-blinded and assessor-blinded, randomised controlled feasibility trial.MethodsTwenty-eight participants with shoulder subacromial pain were randomly allocated into one of two intervention groups-tailored or standardised exercise. Participants in the tailored exercise programme received exercises and manual therapy tailored to their scapular and shoulder movement impairments. Participants in the standardised exercise programme received progressive strengthening exercise. The primary outcome measures were (1) the participant recruitment rate; (2) the proportion of participants enrolled from the total number screened; (3) drop-out rates; and (4) adherence to the rehabilitation programme. Other outcome measures were: (5) pain levels; (6) Patient-Specific Functional Scale; (7) the Shoulder Pain and Disability Index; and (8) pain self-efficacy. We compared changes in pain and disability scores between groups using a repeated mixed-model analysis of variance. Since this is a feasibility study, we did not adjust alpha for multiple comparisons, and considered 75% CI as the probability threshold at 3-month follow-up. Health-related quality of life was assessed using the Short-Form 12 and quality-adjusted life years (QALYs) were estimated.ResultsThe recruitment rate was 3 participants per month, the proportion of participants enrolled was 23%, the drop-out rate was 14% and the overall adherence to the rehabilitation programme was 85%. No between-group differences were found for most outcome measures. Adverse events (n=2, only in the tailored group) were minor in nature and included skin injury or pain following taping.ConclusionsOur feasibility trial showed that additional strategies are required for improving recruitment, enrolment and minimising drop-out of participants into the trial and making it feasible to conduct a full trial.Trial registration numberANZCTR: 12617001405303.

Project description:IntroductionShoulder pain is common and the prognosis is often unfavourable. Dutch guidelines on the treatment of shoulder pain in primary care recommend a corticosteroid injection or a referral to exercise therapy, if initial pain management fails and pain persists. However, evidence of the effectiveness of a corticosteroid injection compared with exercise therapy, especially in the long term, is limited. This trial will assess the clinical effectiveness and cost effectiveness of a corticosteroid injection compared with physiotherapist-led exercise therapy over 12 months follow-up in patients with shoulder pain in primary care.Methods and analysisThe SIX Study is a multicentre, pragmatic randomised clinical trial in primary care. A total of 213 patients with shoulder pain, aged ≥18 years presenting in general practice will be included. Patients will be randomised (1:1) into two groups: a corticosteroid injection or 12 sessions of physiotherapist-led exercise therapy. The effect of the allocated treatment will be assessed through questionnaires at 6 weeks and after 3, 6, 9 and 12 months. The primary outcome is patient's reported shoulder pain-intensity and function, measured with the Shoulder Pain and Disability Index, over 12 months follow-up. Secondary outcomes include cost effectiveness, pain-intensity, function, health-related quality of life, sleep quality, patient's global perceived effect, work absence, healthcare utilisation and adverse events. Between group differences will be evaluated using a repeated measurements analysis with linear effects models. A cost-utility analysis will be performed to assess the cost effectiveness using quality-adjusted life years from a medical and societal perspective.Ethics and disseminationThis study was approved by the Medical Ethics Committee of Erasmus MC University Medical Center Rotterdam (MEC 2020-0300). All participants will give written informed consent prior to data collection. The results from this study will be disseminated in international journals and implemented in the primary care guidelines on shoulder pain.Trial registration numberDutch Trial Registry (NL8854).

Project description:BACKGROUND:Subacromial impingement syndrome (SIS) is a painful, and often long lasting, shoulder condition affecting patient function and quality of life. In a recent study, we observed major strength impairments in shoulder external rotation and abduction (~30%) in a population of patients with pronounced and long-lasting SIS. However, the current rehabilitation of such strength impairments may be inadequate, with novel rehabilitation programmes including exercise therapy only improving external rotation strength by 4-13%. As these previous studies are the basis of current practice, this suggests that the strengthening component could be inadequate in the rehabilitation of these patients, and it seems likely that more emphasis should be placed on intensifying this part of the rehabilitation. The purpose of this study is to investigate the effectiveness of a programme consisting of progressive home-based resistance training using an elastic band, aimed at improving shoulder external rotation and abduction strength, added to usual care and initiated shortly after diagnosis has been established. METHODS:A pragmatic randomised controlled superiority trial will be conducted, including 200 patients with pronounced and long-lasting SIS, diagnosed using predefined criteria. Participants will be randomised to receive either an add-on intervention of progressive home-based resistance training using an elastic band in addition to usual care or usual care alone in a 1:1 allocation ratio. The randomisation sequence is computer generated, with permuted blocks of random sizes. The primary outcome will be change in Shoulder Pain And Disability Index (SPADI) score from baseline to 16 weeks follow-up. Outcome assessors are blinded to group allocation. Intervention receivers will be kept blind to treatment allocation through minimal information about the content of the add-on intervention and control condition until group allocation is final. Analyses are performed by blinded data analysts. DISCUSSION:If effective, the simple shoulder strengthening exercise programme investigated in this trial could easily be added to usual care. The usefulness of the trial is further supported by the magnitude of the problem, the information gained from the study and the pragmatism, patient centeredness and transparency of the trial. TRIAL REGISTRATION:The trial is pre-registered at ClinicalTrials.gov with the ID NCT02747251 on April 19, 2016.

Project description:BackgroundMost individuals with spinal cord injury who use manual wheelchairs experience shoulder pain related to wheelchair use, potentially in part from mechanical impingement of soft tissue structures within the subacromial space. There is evidence suggesting that scapula and humerus motion during certain wheelchair tasks occurs in directions that may reduce the subacromial space, but it hasn't been thoroughly characterized in this context.MethodsShoulder motion was imaged and quantified during scapular plane elevation with/without handheld load, propulsion with/without added resistance, sideways lean, and weight-relief raise in ten manual wheelchair users with spinal cord injury using biplane fluoroscopy and computed tomography. For each position, minimum distance between rotator cuff tendon insertions (infraspinatus, subscapularis, supraspinatus) and the coracoacromial arch was determined. Tendon thickness was measured with ultrasound, and impingement risk scores were defined for each task based on frequency and amount of tendon compression.FindingsPeriods of impingement were identified during scapular plane elevation and propulsion but not during pressure reliefs in most participants. There was a significant effect of activity on impingement risk scores (P < 0.0001), with greatest impingement risk during scapular plane elevation followed by propulsion. Impingement risk scores were not significantly different between scapular plane elevation loading conditions (P = 0.202) or propulsion resistances (P = 0.223). The infraspinatus and supraspinatus tendons were both susceptible to impingement during scapular plane elevation (by acromion), whereas the supraspinatus was most susceptible during propulsion (by acromion and coracoacromial ligament).InterpretationThe occurrence of mechanical impingement during certain manual wheelchair tasks, even without increased load/resistance, demonstrates the importance of kinematics inherent to a task as a determinant of impingement. Frequency of and technique used to complete daily tasks should be carefully considered to reduce impingement risk, which may help preserve shoulder health long-term.

Dataset Information

A manual physical therapy approach versus subacromial corticosteroid injection for treatment of shoulder impingement syndrome: a protocol for a randomised clinical trial.

Publications

A manual physical therapy approach versus subacromial corticosteroid injection for treatment of shoulder impingement syndrome: a protocol for a randomised clinical trial.

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