Clinical trial Recruiting at 10 sites Interventional Ages 18 to 65

Empowered Relief and Exercise Rehab for Subacromial Shoulder Pain

Official title: Pain, Expectations, Beliefs and Behaviour: Untying the Knot to Guide Care

Run by University College Copenhagen · NCT07791784 · Data updated 2026-11-12

This study tests whether a single 2-hour online Empowered Relief session helps adults with subacromial shoulder pain stick with a 12-week home exercise program and see if their pain-related thoughts change.

More Subacromial Pain Syndrome trials

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment60 (estimated)
SponsorUniversity College Copenhagen
Academic / other
Locations10 sites (Ballerup Municipality and 9 other locations)
StatusRecruiting
StartedSeptember 2, 2026
Main results expectedJune 2027
Study endsJune 2027
Registry record updatedNovember 10, 2026
Trial IDNCT07791784 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–65 with at least 3 months of subacromial shoulder pain, Danish language proficiency, and a PCS score >16.

Probably not a fit

Individuals with recent shoulder surgery, current long-term strong analgesic use, fracture, osteoarthritis of the shoulder, or recent corticosteroid injections may see limited benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses a multiple-baseline single-case design to evaluate a brief pain-skills session added to a standard 12-week shoulder exercise program. All participants complete the same exercise plan, while the Empowered Relief session is scheduled between day 10 and day 26 after starting the program. Researchers compare outcomes before and after the session within each participant to understand effects on pain beliefs and exercise adherence. The program targets shoulder external rotation, abduction, and flexion with progressively adapted resistance, and includes daily self-reported questions over 12 weeks. The trial is conducted across several Danish sites with certified instructors delivering the online session.

Why it matters

Potential benefit: If successful, Empowered Relief could help reduce unhelpful pain beliefs and improve adherence to a beneficial exercise program for subacromial shoulder pain.

How similar studies have gone: Previous work with brief pain-skills interventions alongside exercise has shown promise, but this exact single-case, randomized timing design is relatively novel in SAPS care.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age 18 to 65 years, inclusive.
* Shoulder pain for at least 3 months.
* Sufficient Danish language proficiency to understand study information, follow instructions, and complete questionnaires.
* Diagnosis of subacromial pain syndrome (SAPS), confirmed by either:
* an existing clinical diagnosis provided by a referring clinician, or
* a standardized study-based clinical examination with at least 3 of the following 5 tests positive: Painful Arc test, Empty Can (Jobe's) test, Neer's test, Hawkins-Kennedy test, and External Rotation Resistance test.
* Pain Catastrophizing Scale (PCS) score greater than 16.

Exclusion Criteria:

* Current regular use of strong analgesic medication, excluding over-the-counter medication.
* Pregnancy.
* Referral for postoperative shoulder rehabilitation.
* Corticosteroid injection in the affected shoulder within the past 2 months.
* Current fracture of the affected shoulder, radiographically verified.
* Glenohumeral osteoarthritis in the affected shoulder, radiographically verified.
* History of shoulder dislocation or subluxation in the affected shoulder.
* Suspected labral lesion of the affected shoulder.
* Suspected full-thickness rotator cuff tear.
* Suspected frozen shoulder (adhesive capsulitis).
* Presence of competing conditions that may explain the shoulder pain or interfere with participation, including but not limited to cancer, inflammatory rheumatic disease, neurological disorders, fibromyalgia, or severe psychiatric disease.

Where it's running

  • Ballerup Municipality
    Ballerup Municipality, Denmark
    Recruiting
  • Copenhagen Municipality, Amager Rehabilitation Center
    Copenhagen, Denmark
    Recruiting
  • Frederiksberg Municipality
    Frederiksberg, Denmark
    Recruiting
  • Hvidovre Municipality
    Hvidovre, Denmark
    Recruiting
  • Fredensborg Municipality
    Kokkedal, Denmark
    Recruiting
  • Køge Municipality
    Køge, Denmark
    Recruiting
Show 4 more locations
  • Lolland Municipality
    Maribo, Denmark
    Recruiting
  • Rødovre Municipality
    Rødovre Municipality, Denmark
    Recruiting
  • Høje-Taastrup Municipality
    Taastrup, Denmark
    Recruiting
  • Furesø Municipality
    Værløse, Denmark
    Recruiting

Study contacts

  • Principal investigator: Mikkel Bek Clausen, Phd, Associate professor — University College Copenhagen
  • Study coordinator: Lars Bo Jørgensen, PhD
  • Email: larj@kp.dk
  • Phone: +45 23488716

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.