An interventional study of Personalised, Multimodal Educational Intervention and Usual Physiotherapy Care in Rotator Cuff-related Shoulder Pain, Shoulder Pain and Shoulder Disability, sponsored by Centre Hospitalier Régional d'Orléans. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Treatment
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.
This multicentre pragmatic randomized controlled non-inferiority trial will recruit 118 adults with acute non-traumatic rotator cuff-related shoulder pain of less than six weeks duration.
Participants will be randomly allocated (1:1) to one of two treatment groups:
Experimental group: Personalised, multimodal educational intervention. Control group: Usual physiotherapy care. Participants allocated to the experimental strategy will receive a personalised, multimodal educational intervention. The intervention targets understanding of shoulder anatomy and function, understanding of the condition, reassurance through contemporary explanations of pain, identification and modification of unhelpful pain-related beliefs and responses, pain self-efficacy, recovery expectations, graded exposure to physical activity and daily activities, and health literacy. It may be delivered through a written educational guide, a study website hosting video resources, and individual educational consultations, in combinations agreed between participant and physiotherapist through shared decision making.
The control group will receive routine physiotherapy management according to current clinical practice and clinical guidelines. Treatment may combine therapeutic exercise, verbal education, manual therapy and other adjunctive treatments in routine use, at the discretion of the treating physiotherapist. Therapeutic exercise is expected to be the central component and is what distinguishes the comparator from the experimental strategy.
Assessments will be performed at baseline, 6 weeks, 12 weeks and 24 weeks. The primary endpoint is change in the Shoulder Pain and Disability Index (SPADI) score at 12 weeks. Secondary outcomes include physical function, pain self-efficacy, fear-avoidance beliefs, health-related quality of life, sleep quality, patient acceptable symptom state, treatment satisfaction and direct and indirect healthcare costs.
The first 10 months of recruitment form an internal pilot phase with prespecified progression criteria: rate of screened participants who consent to participate in the trial, number of participants recruited, number of centres that recruited at least 3 participants over a 10-month period.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's planned enrollment of 118 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Centre Hospitalier Régional d'Orléans is the lead sponsor of 129 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive a personalised educational intervention including educational materials, digital resources and up to eight consultations with a physiotherapist during a 12-week intervention period.
Behavioral: Personalised, Multimodal Educational Intervention
Participants receive up to eight consultations routine physiotherapy management for acute rotator cuff-related shoulder pain according to current clinical practice.
Behavioral: Usual Physiotherapy Care
Participants 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.
Participants 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.
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 12
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 24
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 24
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 24
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 24
Health-Related Quality of Life (EQ-5D-5L)
The EQ-5D-5L assesses mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Health states are converted into utility scores using the French value set.
Time frame: Baseline, Week 6, Week 12, and Week 24
Pittsburgh Sleep Quality Index (PSQI)
The PSQI generates a global score from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Baseline, Week 6, Week 12 and Week 24
Patient Acceptable Symptom State (PASS) at 12 weeks
The Patient Acceptable Symptom State (PASS) determines whether participants consider their current symptom level acceptable. The proportion of participants achieving PASS will be compared between groups.
Time frame: Week 12
Patient Satisfaction With Treatment at 12 weeks
Eight items covering respect for values, preferences and needs; coordination and integration of care; information, communication and education; physical comfort; emotional support; involvement of family and relatives; transition and continuity of care; and accessibility of care. Each item is rated from not at all satisfied to completely satisfied, with a not applicable option
Time frame: Week 12
Direct Healthcare Costs
Direct healthcare resource use related to shoulder pain, comprising physiotherapy consultations, shoulder-related imaging investigations, prescribed medications and consultations with other healthcare professionals, valued using French statutory health insurance tariffs. The reported metric is the mean cost per participant in each group.
Time frame: Baseline to Week 24
Indirect Costs and Work Productivity Loss
Productivity losses arising from work absence attributable to shoulder pain, estimated from the number of workdays lost and self-reported gross income among participants in remunerated employment or self-employment. The reported metric is the mean cost per participant in each group.
Time frame: Baseline to Week 24
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Centre Hospitalier Régional d'Orléans