Dataset Information

Efficacy of five-step shoulder manipulation for rotator cuff-related shoulder pain: protocol for a multicenter randomized controlled trial.

ABSTRACT:

Background

Rotator cuff-related shoulder pain (RCRSP) is the most common cause of shoulder disorders. In China, manipulation has been used extensively for the treatment of patients with RCRSP. However, high-quality clinical evidence to support the therapeutic effect of manipulation is still limited.

Methods

A multicenter, participant-, outcome assessor-, and data analyst-blinded, randomized, placebo-controlled trial will be conducted. A total of 280 participants with RCRSP will be recruited from three hospitals and randomly assigned to a five-step shoulder manipulation (FSM) group or a sham manipulation (SM) group. Each group will receive four weekly treatment sessions, with all participants performing exercises at home for 12 weeks. Assessments, namely the Constant-Murley score, visual analog scale, range of motion, and 36-Item Short Form Survey, will be made at baseline, 4, 12, 18, and 24 weeks. Adverse events during the study will also be recorded.

Discussion

This is a pragmatic clinical trial to evaluate the efficacy and safety of FSM in patients with RCRSP. The findings of this study will provide worthy clinical evidence for manual therapy for RCRSP.

Trial registration

China Registered Clinical Trial Registration Center ChiCTR2000037577. Registered on 29 August 2020.

SUBMITTER: Liu S

PROVIDER: S-EPMC10405406 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Efficacy of five-step shoulder manipulation for rotator cuff-related shoulder pain: protocol for a multicenter randomized controlled trial.

Liu Shuang S Liu Jin-Tao JT Chen Lin L Fan Tian-You TY Cui Xue-Jun XJ Cheng Shao-Dan SD Chen Yan-Jiao YJ Shi Qi Q Xue Chun-Chun CC Li Xiao-Feng XF

Trials 20230807 1

<h4>Background</h4>Rotator cuff-related shoulder pain (RCRSP) is the most common cause of shoulder disorders. In China, manipulation has been used extensively for the treatment of patients with RCRSP. However, high-quality clinical evidence to support the therapeutic effect of manipulation is still limited.<h4>Methods</h4>A multicenter, participant-, outcome assessor-, and data analyst-blinded, randomized, placebo-controlled trial will be conducted. A total of 280 participants with RCRSP will be ...[more]

PMID: 37550698

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Project description:Introduction Rotator cuff-related shoulder pain is the most common diagnosis of shoulder pain, which ranks as the third most common musculoskeletal disorder. The first-line treatment for patients with rotator cuff-related shoulder pain is physiotherapy, and joint mobilisation is widely used in conjunction with other modalities. The type and dosage of joint mobilisations could influence treatment outcomes for patients with rotator cuff-related shoulder pain, although research evidence is inconclusive. Objectives To (1) systematically search, identify and map the reported type and dosage of joint mobilisations used in previous studies for the management of patients with rotator cuff-related shoulder pain; and (2) summarise the rationale for adopting a specific joint mobilisation dosage. Methods and analysis We will follow the methodological framework outlined by Arksey and O’Malley and report the results as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guideline. Two authors will independently screen and extract data from the six databases: PubMed, Scopus, Web of Science, CINAHL, Cochrane Library and SPORTDiscus, with publication date from their inceptions to 25 August 2021. A third author will be consulted if the two authors disagree about the inclusion of any study in the review. We will summarise the results using descriptive statistics and qualitative thematic analysis. Ethics and dissemination Ethical approval is not required for this protocol. Mapping and summarising the reported type and dosage of joint mobilisations for patients with rotator cuff-related shoulder pain from previous studies will provide a foundation for further optimal selection of type and dosage of joint mobilisations for treating patients with rotator cuff-related shoulder pain. The review is part of an ongoing research that focuses on joint mobilisation for patients with rotator cuff-related shoulder pain. The results will be disseminated through presentations at academic conferences and a peer-reviewed publication.

Project description:IntroductionLifetime 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 analysisIn 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 disseminationEthics 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 numberNCT03892603; pre-results.

Project description:ObjectivesThis study evaluated the feasibility of exercising into pain in rotator cuff related shoulder pain (RCRSP), data collection procedures, feedback from physiotherapists and patients, and clinically important changes in patient-reported outcome measures (PROMs).DesignUnblinded non-randomised single-group study.SettingPhysiotherapy clinic in Belgium.ParticipantsTwelve patients with unilateral RCRSP for minimum 3 months, aged 18-65 years.InterventionsTwelve weeks of four individualised exercises, with nine physiotherapist-led sessions with pain ratings 4-7 out of 10 on a verbal Numeric Pain Rating Scale for 9 weeks and then pain ratings 0-2 for 3 weeks. Every physiotherapy session included 15 min of manual therapy. Non-supervised exercises were: 2×/week in weeks with physiotherapy session, 3×/week in weeks without physiotherapy session.Outcome measuresPrimary: adherence, where patients were considered adherent with 78% (7/9 sessions) attendance for supervised sessions and 81% (22/27 sessions) completion for non-supervised exercises, and Shoulder Pain and Disability Index (SPADI); secondary: fear-avoidance behaviour, fear of pain, physical outcomes (strength, range of motion, scapular dyskinesis); others: ultrasound (US) imaging outcomes (acromionhumeral distance, supraspinatus tendon thickness, occupation ratio), global perceived effect (GPE). PROMs were collected via online survey, except for the GPE (via closed envelope). US measures were taken after physical measures.ResultsAdherence and adverse effects were analysed in patients who had the possibility to attend minimum seven supervised sessions (n=8): 88% of them adhered to supervised sessions, 50% to non-supervised exercises; none of them withdrew from the study, three of them obtained individual clinically important improvements in SPADI score above 20 points. The measurement protocol of physical and ultrasonographic outcomes took around 60 min.ConclusionsAdherence to supervised sessions was satisfactory, the adherence to non-supervised exercises must be improved. Data collection procedures were feasible to perform, but some changes are recommended.Trial registration numberNCT04154345.

Project description:BackgroundKinesiotaping (KT) has been widely used in clinical practice. Current evidence is insufficient to support the use of KT for treating rotator cuff-related shoulder pain (RCRSP), as its mid- and long-term effects have not been investigated.HypothesesIndividuals using KT will achieve faster improvements in symptoms and functional limitations compared with those not using it. They will also present a greater increase in pain-free range of motion (ROM) and acromiohumeral distance (AHD) at the end of the treatment.Study designRandomized controlled trial (NCT02881021).Level of evidenceTherapy, level 1b.MethodsA total of 52 individuals with RCRSP, randomly assigned to 1 of 2 groups (experimental: KT; control: no-KT), underwent a 6-week rehabilitation program composed of 10 physical therapy sessions. KT was added to the treatment of the KT group. Symptoms and functional limitations were assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire (primary outcome); Brief Pain Inventory (BPI); and Western Ontario Rotator Cuff (WORC) index at baseline, 3 weeks, 6 weeks, 12 weeks, and 6 months. AHD, pain-free ROM, and full ROM were measured at baseline and at week 6. The effects of KT were assessed using a nonparametric analysis for longitudinal data.ResultsNo significant group × time interactions (0.112 ≤ P ≤ 0.726) were found for all outcomes. Time effects were observed as both groups showed significant improvements for all studied outcomes (DASH, BPI, and WORC, p < 0.0001; AHD, p = 0.017; pain-free ROM, p < 0.0001; and full ROM abduction, p ≤ 0.0001).ConclusionWhereas symptoms, functional limitations, ROM, and AHD improved in both groups, the addition of KT did not lead to superior outcomes compared with exercise-based treatment alone, in the mid and long term, for individuals with RCRSP.Clinical relevanceClinicians should not expect supplementary mid- or long-term gains with KT to reduce pain, improve shoulder function and ROM, or increase AHD if a rehabilitation program focusing on shoulder neuromuscular control is concurrently provided as treatment for individuals with RCRSP.

Project description:PurposeTo compare patient-reported and surgical outcome measures in patients with and without secondary shoulder stiffness (SSS) undergoing rotator cuff repair (RCR).MethodsPatients undergoing rotator cuff repair from 2014 to 2020 with complete patient-reported outcome measures (PROMs) by the short-form 12 survey (SF-12) were retrospectively reviewed to identify if operative intervention for SSS was performed alongside the RCR. Those patients with operative intervention for SSS were propensity matched to a group without prior intervention for stiffness by age, sex, laterality, body mass index, diabetes mellitus status, and the presence of a thyroid disorder. The groups were compared by rotator cuff tear (RCT) size, surgical outcomes, further surgical intervention, rotator cuff retear rate, postoperative range of motion (ROM), and SF-12 results at 1 year after surgery. Delta values were calculated for component scores of the SF-12 and ROM values by subtracting the preoperative result from the postoperative result.ResultsA total of 89 patients with SSS were compared to 156 patients in the control group at final analysis. The patients in the SSS group experienced a significant improvement in the delta mental health component score (MCS-12) of the SF-12 survey that was not seen in the control group (P = .005 to P = .539). Both groups experienced significant improvement by the delta physical health component score (PCS-12) of the SF-12 survey (SSS: 7.68; P < .001; control: 6.95; P < .001). The SSS group also experienced greater improvement of their forward flexion (25.8° vs 12.9°; P = .005) and external rotation (7.13° vs 1.65°; P = .031) ROM than the control group.ConclusionsOperative intervention of SSS at the time of RCR has equivalent postoperative SF-12 survey outcome scores when compared to patients undergoing RCR without preoperative stiffness despite those patients having lower preoperative scores.Level of evidenceLevel III retrospective comparative study.

Project description:Calcific tendinopathy of the shoulder (CTS) is the most common cause of shoulder pain. Conservative treatment is considered as the first therapeutic choice for CTS. The main objective of this study was to assess the effect of US-guided needling (UGN) compared to UGN plus Biocompatible Electrical Neurostimulation (BEN) in the treatment of the CTS. Pilot, prospective, non-interventional, monocentric, and observational study of patients treated for calcific rotator cuff tendinopathy and shoulder pain. Patients' selection, enrollment and interventions were conducted at the Chiparo Physical Medicine and Rehabilitation outpatient facility. Forty adult patients (aged 40-60 years) with a diagnosis of CTS in the acute and colliquative phase were recruited and enrolled into the study. Participants were assessed for self-perceived pain through the Numerical Rating Scale (NRS), and for functional limitation through the Shoulder Pain and Disability Index score (SPADI) at baseline (T0), after 15 days (T1), and after 40 days (T2). As a possible confounding factor between the two treatments' response, the dimension of the tendon calcification was also assessed by US-examination. Through the study, both groups improved their perceived functional performance of the arm (p-value < 0.001). AT T1, the SPADI score decreased by half in both groups, and the improvement remained stable at T2. A multiplicative effect (Time × Treatment) was demonstrated (p-value < 0.001). An improvement in the NRS score was measured at T1, and it remained stable at T2, a multiplicative effect was also reported (p-value < 0.001). The main results of this pilot study provide evidence that UGN plus BEN increases functional performance and reduces shoulder pain in individuals with CTS. Moreover, the tendon calcification dimension at the baseline and the percentage of drainage of the lesion were associated with a functional performance recovery and pain reduction detected after intervention.

Dataset Information

Efficacy of five-step shoulder manipulation for rotator cuff-related shoulder pain: protocol for a multicenter randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Efficacy of five-step shoulder manipulation for rotator cuff-related shoulder pain: protocol for a multicenter randomized controlled trial.

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