Personalised Education Versus Usual Physiotherapy for Acute Rotator Cuff-Related Shoulder Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional d'Orléans
About this trial
Rotator cuff-related shoulder pain (RCRSP) is one of the most common musculoskeletal disorders presenting in primary care. It is frequently associated with persistent pain, disability, healthcare utilisation and work absenteeism. Exercise-based physiotherapy is recommended as first-line management in clinical practice guidelines, yet its average effects on pain and disability are modest and a substantial proportion of people remain symptomatic several months after onset. Patient education is also recommended, and trials conducted in people with persistent symptoms suggest that education-based care may produce improvements comparable to those obtained with progressive exercise. However, the effectiveness of a structured educational intervention as a first-line management strategy during the acute phase of RCRSP remains unclear.
SHOULD Education lead Rehabilitation? (SHOULD-ER) is a multicentre, pragmatic, parallel-group, non-inferiority randomised controlled trial comparing a personalised, multimodal educational intervention with usual physiotherapy care in adults presenting with acute non-traumatic RCRSP of less than six weeks duration. Participants will be randomly assigned to one of the trial arms for a 12-week treatment period, with follow-up to 24 weeks.
The primary objective is to determine whether the educational intervention is non-inferior to usual physiotherapy care regarding improvement in shoulder pain and disability at 12 weeks, measured by the Shoulder Pain and Disability Index (SPADI). Secondary outcomes include pain-related function, self-efficacy, fear-avoidance beliefs, quality of life, sleep quality, patient satisfaction and healthcare costs.
A nested qualitative study and a within-trial economic evaluation are embedded in the trial. An exploratory analysis of prognostic factors will also be conducted with a secondary analysis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Able to speak and understand French
Affiliated with a French health insurance system
Available for study follow-up
Disqualifiers
Previous traumatic shoulder injury potentially causing rotator cuff tear, capsuloligamentous or labral injury, fracture, or dislocation involving the shoulder complex
Clinical signs of massive rotator cuff tear
Referred or cervical radicular pain
Cervical radiculopathy, neuropathic pain or upper-limb neuropathy
Trial design
Design model
Parallel
Treatments tested in this trial
Personalised, Multimodal Educational Intervention
BehavioralParticipants receive a personalised, multimodal educational intervention over a maximum of 12 weeks. Delivery may combine a written educational guide, a study website hosting video resources, and up to eight individual educational consultations of approximately 30 minutes. The content and the combination of components are agreed between participant and physiotherapist through shared decision making. No structured therapeutic exercise programme is prescribed, and participants in this group do not receive usual physiotherapy care in addition. The intervention aims to improve understanding of shoulder pain, self-management skills, confidence in movement and return to normal activities.
Usual Physiotherapy Care
BehavioralParticipants receive usual physiotherapy care over a maximum of 12 weeks, comprising up to eight supervised consultations of approximately 30 minutes delivered according to current clinical practice. Treatment may combine therapeutic exercise, verbal education, manual therapy and other adjunctive treatments in routine use, at the discretion of the treating physiotherapist.
Treatment groups
118 Participants
are divided into 2 treatment groupsGroup A: Personalised, Multimodal Educational InterventionExperimental treatment 1 intervention
Group B: Usual Physiotherapy CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Shoulder Pain and Disability Index (SPADI) total Score
The Shoulder Pain and Disability Index (SPADI) is a 13-item participant-reported questionnaire comprising a five-item pain subscale and an eight-item disability subscale. Items are combined and transformed into a total score ranging from 0 to 100, with higher scores indicating greater shoulder pain and disability. The primary endpoint is the between-group difference in SPADI score change from baseline to Week 12.
Time frame
Baseline to Week 12Secondary outcomes
1
Shoulder Pain and Disability Index (SPADI) total score trajectory
Longitudinal course of the SPADI total score, scored from 0 to 100 with higher scores indicating greater shoulder pain and disability.
Time frame
Baseline, Week 6, Week 12, and Week 242
Patient-Specific Functional Scale (PSFS)
Participants nominate activities they find difficult because of their shoulder and rate each from 0 to 10, with higher scores indicating greater ability to perform the activity.
Time frame
Baseline, Week 6, Week 12, and Week 243
Pain Self-Efficacy Questionnaire (PSEQ)
The PSEQ comprises 10 items rated from 0 to 6, giving a total score from 0 to 60, with higher scores indicating greater confidence in performing activities despite pain
Time frame
Baseline, Week 6, Week 12, and Week 244
Fear-Avoidance Beliefs Questionnaire - Physical activity subscale (FABQ-PA)
The FABQ-PA measures beliefs about the effect of physical activity on shoulder pain, with higher scores indicating stronger fear-avoidance beliefs.
Time frame
Baseline, Week 6, Week 12, and Week 24Sponsors and contacts
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Source ClinicalTrials.gov
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