A randomised controlled trial of heavy shoulder strengthening exercise in patients with hypermobility spectrum disorder or hypermobile Ehlers-Danlos syndrome and long-lasting shoulder complaints: study protocol for the Shoulder-MOBILEX study

Abstract

Background Four out of five patients with hypermobility spectrum disorder (HSD) or hypermobile Ehlers-Danlos syndrome (hEDS) experience shoulder complaints including persistent pain and instability. Evidence suggests that patients with HSD/hEDS who experience knee and back complaints improve with exercise-based therapy. However, no study has focused on exercise-based treatment for the shoulder in this patient group. The potential benefits of strengthening the shoulder muscles, such as increased muscle-tendon stiffness, may be effective for patients with HSD/hEDS who often display decreased strength and increased shoulder laxity/instability. The primary aim is to investigate the short-term effectiveness of a 16-week progressive heavy shoulder strengthening programme and general advice (HEAVY) compared with low-load training and general advice (LIGHT), on self-reported shoulder symptoms, function, and quality of life. Methods A superiority, parallel group, randomised controlled trial will be conducted with 100 patients from primary care with HSD/hEDS and shoulder complaints (persistent pain and/or instability) for more than 3 months. Participants will be randomised to receive HEAVY (full range of motion, high load) or LIGHT (neutral to midrange of motion, low load) strengthening programme three times weekly with exercises targeting scapular and rotator cuff muscles. HEAVY will be supervised twice weekly, and LIGHT three times during the 16 weeks. The primary outcome will be between-group difference in change from baseline to 16-week follow-up in the Western Ontario Shoulder Instability Index (WOSI, 0-2100 better to worse). Secondary outcomes will include a range of self-reported outcomes covering symptoms, function, and quality of life, besides clinical tests for shoulder strength, laxity/instability, and proprioception. Outcome assessors will be blinded to group allocation. Participants will be kept blind to treatment allocation through minimal information about the intervention content and hypotheses. Primary analyses will be performed by a blinded epidemiologist. Discussion If effective, the current heavy shoulder strengthening programme will challenge the general understanding of prescribing low-load exercise interventions for patients with HSD/hEDS and provide a new treatment strategy. The study will address an important and severe condition using transparent, detailed, and high-quality methods to potentially support a future implementation. Trial registration ClinicalTrials.gov NCT03869307. Registered on 11 March 2019.

Short-term effectiveness of high-load compared with low-load strengthening exercise on self-reported function in patients with hypermobile shoulders: a randomised controlled trial

“…The rationale for using HEAVY was to impact the muscle cross-sectional areas and the voluntary activation of the available muscle mass to pose active joint stability to compensate for the lack of passive stability in hypermobile shoulders 27. However, the mechanisms behind the effect of HEAVY are complex and also include psychosocial aspects and contextual effects 71.…”

“…We ensured fidelity by controlling exercise logs, controlling patient payments from the university office to the clinics (no patients received more than the planned sessions: up to 32 for the intervention group and 3 for the comparator), and we controlled how many dumbbells we gave to the clinics. The trial was prospectively registered on ClinicalTrials.gov, and the trial protocol has previously been published elsewhere 27…”

“…Patients were eligible for inclusion if aged 18–65 and fulfilling the generalised HSD (G-HSD) or historical HSD (H-HSD) criteria 8 28. The criteria for HSD included musculoskeletal manifestations (ie, chronic shoulder pain and/or shoulder instability symptoms for at least 3 months without any cut-off for symptom intensity27) and the presence of generalised joint hypermobility (GJH), which was established using the Beighton score (cut-point of 4 for men of all ages and women ≥50 years and 5 for women <50 years) 28. For H-HSD, a 1-point lower Beighton score was accepted if the patient had a positive 5-part Questionnaire (5PQ) (cut-point of 2) 29.…”

“…The trial was prospectively registered on ClinicalTrials.gov, and the trial protocol has previously been published elsewhere. 27 …”

Clinical Characteristics of 100 Patients With Hypermobility Spectrum Disorders and Shoulder Complaints With or Without Mechanical Symptoms: A Cross-sectional Study

“…This descriptive study used baseline data from a randomised controlled trial (RCT) on patients with HSD and persistent shoulder complaints (The Shoulder-MOBILEX study), 25 approved by the Regional Committees on Health Research Ethics for Southern Denmark ( 31May 2017, S-20170066) and registered with Clinicaltrials.gov (8 Mar 2019, NCT03869307).…”