Rotator Cuff-related Shoulder PainSHOULD-ERNCT07859891
Personalised Education Versus Usual Physiotherapy for Acute Rotator Cuff-Related Shoulder Pain
A study testing Personalised, Multimodal Educational Intervention and Usual Physiotherapy Care in people with Rotator Cuff-related Shoulder Pain and Shoulder Pain, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff-related Shoulder Pain, Shoulder Pain, Shoulder Disability
- What is being tested?
- Personalised, Multimodal Educational Intervention and Usual Physiotherapy Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2026to 17 Oct 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Able to speak and understand French
- Affiliated with a French health insurance system
- Available for study follow-up
- Clinical diagnosis of acute non-traumatic rotator cuff-related shoulder pain of less than 6 weeks' duration: deltoid-region and/or upper arm pain; pain associated with arm movement; familiar pain reproduced during resisted external rotation testing
- Written informed consent obtained
Who cannot join
- 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
- Frozen shoulder
- Glenohumeral instability
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- Glenohumeral, acromioclavicular, or sternoclavicular arthropathy
- Vascular disorders affecting the upper limb
- Inflammatory rheumatic disease affecting the upper limb
- Central neurological disease or cancer affecting the shoulder
- Previous surgery on the painful shoulder
- Current rehabilitation for the present shoulder episode
- Opioid use or corticosteroid injection within 3 months or planned at the enrolment
- Unable to complete questionnaires
- Participation in another clinical trial
- Persons under legal protection
- Administrative or judicial supervision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Laboratoire Sport Activité Physique Rééducation et Motricité pour la performance et la santé (SAPRéM)
Orléans, Loiret, 45067
Alexis RAMOS, PhD, 06 66 60 33 35 ext. +33, alexis.ramos@univ-orleans.fr
Camille PRIMA--CROKAERT, 02 38 74 42 92 ext. +33, camille.prima@chu-orleans.fr
About this study
Official title: Clinical and Cost-Effectiveness of a Personalised, Multimodal Educational Intervention Compared With Usual Physiotherapy Care To Reduce Pain And Disability In Adults With Acute Rotator Cuff-Related Shoulder Pain: A Multicentre, Pragmatic, Parallel-Group, Non-Inferiority Randomised Controlled 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.
Read more
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.
Read the detailed description
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.
- Being tested
- Personalised, Multimodal Educational Intervention, Usual Physiotherapy Care
- Keywords
- Rotator Cuff-Related Shoulder Pain, Shoulder Pain, Patient Education, Physiotherapy, Self-Management, Primary Health Care
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised, Multimodal Educational InterventionBehavioural
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.
Usual Physiotherapy CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalised, Multimodal Educational Intervention | Experimental | 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. Receives: Behavioral: Personalised, Multimodal Educational Intervention |
| Usual Physiotherapy Care | Active comparator | Participants receive up to eight consultations routine physiotherapy management for acute rotator cuff-related shoulder pain according to current clinical practice. Receives: Behavioral: Usual Physiotherapy Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start17 Oct 2026 (estimated)
- Primary completion17 Jul 2029 (estimated)
- Study completion17 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff-related Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric pragmatic non-inferiority randomized controlled trial with two parallel groups. Eligible participants are randomized in a 1:1 ratio to receive either a personalised, multimodal educational intervention or usual physiotherapy care. Follow-up assessments are performed over 24 weeks.
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis RAMOS, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859891
- Sponsor's protocol ID
- CHU d'Orléans
- Acronym
- SHOULD-ER
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Braun, V., & Clarke, V. (2021). To saturate or not to saturate? Questioning data saturation as a useful concept for thematic analysis and sample-size rationales. Qualitative Research in Sport, Exercise and Health, 13(2), 201-216. https://doi.org/10.1080/2159676X.2019.1704846
Braun, V., & Clarke, V. (2013). Successful Qualitative Research : A Practical Guide for Beginners. SAGE.
Braun, V., & Clarke, V. (2022). Thematic analysis : A practical guide. SAGE.
Buchbinder R, Ramiro S, Huang H, Gagnier JJ, Jia Y, Whittle SL. Measures of Adult Shoulder Function. Arthritis Care Res (Hoboken). 2020 Oct;72 Suppl 10:250-293. doi: 10.1002/acr.24230. No abstract available.
PubMed 33091271Bigliani LU, Ticker JB, Flatow EL, Soslowsky LJ, Mow VC. The relationship of acromial architecture to rotator cuff disease. Clin Sports Med. 1991 Oct;10(4):823-38.
PubMed 1934099Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clin Epidemiol. 2018 Jan 18;10:153-157. doi: 10.2147/CLEP.S146397. eCollection 2018.
PubMed 29403314Bedi A, Bishop J, Keener J, Lansdown DA, Levy O, MacDonald P, Maffulli N, Oh JH, Sabesan VJ, Sanchez-Sotelo J, Williams RJ 3rd, Feeley BT. Rotator cuff tears. Nat Rev Dis Primers. 2024 Feb 8;10(1):8. doi: 10.1038/s41572-024-00492-3.
PubMed 38332156Babatunde OO, Ensor J, Littlewood C, Chesterton L, Jordan JL, Corp N, Wynne-Jones G, Roddy E, Foster NE, van der Windt DA. Comparative effectiveness of treatment options for subacromial shoulder conditions: a systematic review and network meta-analysis. Ther Adv Musculoskelet Dis. 2021 Sep 9;13:1759720X211037530. doi: 10.1177/1759720X211037530. eCollection 2021.
PubMed 34527083Axelsson E. Equivalence and non-inferiority trials in the evaluation of non-pharmacological interventions: rationale, challenges and recommendations. BMJ Open. 2025 Aug 31;15(8):e102996. doi: 10.1136/bmjopen-2025-102996.
PubMed 40887112ARMSTRONG JR. The supraspinatus syndrome. Lancet. 1947 Jan 18;1(6438):94-6. doi: 10.1016/s0140-6736(47)91045-3. No abstract available.
PubMed 20281016Andrade LF, Ludwig K, Goni JMR, Oppe M, de Pouvourville G. A French Value Set for the EQ-5D-5L. Pharmacoeconomics. 2020 Apr;38(4):413-425. doi: 10.1007/s40273-019-00876-4.
PubMed 31912325