Empowered Relief and Exercise Rehabilitation for People With Subacromial Shoulder Pain

NCT07791784 | Not Yet Recruiting

• 2 other identifiers: Alias: 20093810.46540/4308-00113B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

Brief Summary

The goal of this clinical trial is to learn whether a single 2-hour online pain skills session called Empowered Relief can help adults with subacromial shoulder pain who are taking part in a 12-week exercise program. The main questions it aims to answer are:

• Does Empowered Relief lower unhelpful thoughts and beliefs about pain?
• Does Empowered Relief help participants complete more of their prescribed exercises? All participants will receive the same 12-week exercise program and the Empowered Relief session. The timing of the Empowered Relief session will be randomly assigned between day 10 and day 26 after starting the exercise program. This allows researchers to compare each participant's responses before and after the session. Participants will:
• Follow a 12-week home exercise program for their shoulder.
• Take part in one 2-hour online Empowered Relief session.
• Answer brief daily questions for 12 weeks about their thoughts about pain, what they expect to feel during exercise, what they actually feel after exercise, and how much of their exercise program they complete.
• Answer brief weekly questions after their Empowered Relief session about their use of the strategies taught in the session.
• Complete longer questionnaires at the start of the study and after 4, 8, and 12 weeks.

Conditions

Subacromial Pain Syndrome

Keywords

Subacromial Shoulder Pain; Pain Catastrophizing; Exercise Adherence; Empowered Relief; Exercise Therapy; Rehabilitation; Pain Self-Efficacy; Single-Case Experimental Design

Outcome Measures

Primary Outcomes (11)

• Daily Pain Catastrophizing

  Pain catastrophizing is assessed daily using a validated 2-item version of the catastrophizing subscale from the Coping Strategies Questionnaire and is part of the outcome domain 'pain-related beliefs'. Each item is scored from 0 to 10, and the mean of the 2 items is used as the daily score. Higher scores indicate greater pain catastrophizing. The outcome is collected daily for 12 weeks. The prespecified primary analysis includes observations collected during the first 8 weeks; observations from weeks 9-12 are used in secondary/exploratory analyses.

  Daily for 12 weeks.

• Daily Fear Avoidance

  Fear avoidance is assessed daily using a validated 2-item version of the Fear-Avoidance Beliefs Questionnaire physical activity subscale, adapted to refer to the shoulder and is part of the outcome domain 'pain-related beliefs'. Each item is scored from 0 to 10, and the mean of the 2 items is used as the daily score. Higher scores indicate greater fear avoidance. The outcome is collected daily for 12 weeks. The prespecified primary analysis includes observations collected during the first 8 weeks; observations from weeks 9-12 are used in secondary/exploratory analyses.

  Daily for 12 weeks.

• Daily Pain Self-Efficacy

  Pain self-efficacy is assessed daily using a validated 2-item version of the Pain Self-Efficacy Questionnaire and is part of the outcome domain 'pain-related beliefs'. Each item is scored from 0 to 6, and the 2 items are summed to give a total daily score from 0 to 12. Higher scores indicate greater confidence in performing activities despite pain. The outcome is collected daily for 12 weeks. The prespecified primary analysis includes observations collected during the first 8 weeks; observations from weeks 9-12 are used in secondary/exploratory analyses.

  Daily for 12 weeks.

• Daily Expected Pain Intensity

  Expected pain intensity is assessed daily using a numeric rating scale from 0 to 10 and is part of the outcome domain 'expected pain responses to exercise'. Participants rate the pain intensity they expect to experience when performing their exercise program. Higher scores indicate greater expected pain intensity. The outcome is collected daily for 12 weeks. The prespecified primary analysis includes observations collected during the first 8 weeks; observations from weeks 9-12 are used in secondary/exploratory analyses.

  Daily for 12 weeks.

• Daily Expected Duration of Pain Aggravation

  Expected duration of pain aggravation is assessed daily using a 7-category ordinal scale from 0 to 6 and is part of the outcome domain 'expected pain responses to exercise'. Participants rate how long they expect any increase in pain following the exercise program to last. A score of 0 indicates no expected aggravation, while a score of 6 indicates that symptoms are not expected to have returned to normal by the following morning. The outcome is collected daily for 12 weeks. The prespecified primary analysis includes observations collected during the first 8 weeks; observations from weeks 9-12 are used in secondary/exploratory analyses.

  Daily for 12 weeks.

• Daily Expected Change in Symptoms

  Expected change in symptoms is assessed daily using a 5-point Likert scale and is part of the outcome domain 'expected pain responses to exercise'. Participants rate how they expect their shoulder symptoms to change following the exercise program, from 1 = much worse to 5 = much better. Higher scores indicate a more favorable expected change in symptoms. The outcome is collected daily for 12 weeks. The prespecified primary analysis includes observations collected during the first 8 weeks; observations from weeks 9-12 are used in secondary/exploratory analyses.

  Daily for 12 weeks.

• Daily Actual Pain Intensity

  Actual pain intensity is assessed daily using a numeric rating scale from 0 to 10 and is part of the outcome domain 'actual pain responses following exercise'. Participants rate the pain intensity they experienced after performing their exercise program. Higher scores indicate greater actual pain intensity. The outcome is collected daily for 12 weeks. The prespecified primary analysis includes observations collected during the first 8 weeks; observations from weeks 9-12 are used in secondary/exploratory analyses.

  Daily for 12 weeks.

• Daily Actual Duration of Pain Aggravation

  Actual duration of pain aggravation is assessed daily using a 7-category ordinal scale from 0 to 6 and is part of the outcome domain 'actual pain responses following exercise'. Participants rate how long any increase in pain following the exercise program actually lasted. A score of 0 indicates no aggravation, while a score of 6 indicates that symptoms had not returned to normal by the following morning. The outcome is collected daily for 12 weeks. The prespecified primary analysis includes observations collected during the first 8 weeks; observations from weeks 9-12 are used in secondary/exploratory analyses.

  Daily for 12 weeks.

• Daily Actual Change in Symptoms

  Actual change in symptoms is assessed daily using a 5-point Likert scale and is part of the outcome domain 'actual pain responses following exercise'. Participants rate how their shoulder symptoms changed following the exercise program, from 1 = much worse to 5 = much better. Higher scores indicate a more favorable actual change in symptoms. The outcome is collected daily for 12 weeks. The prespecified primary analysis includes observations collected during the first 8 weeks; observations from weeks 9-12 are used in secondary/exploratory analyses.

  Daily for 12 weeks.

• Daily Time Spent on Exercise Program

  Exercise adherence is assessed daily by asking participants to report the number of minutes spent performing the exercises included in their prescribed exercise program. Higher values indicate more time spent exercising. The outcome is collected daily for 12 weeks. The prespecified primary analysis includes observations collected during the first 8 weeks; observations from weeks 9-12 are used in secondary/exploratory analyses.

  Daily for 12 weeks.

• Daily Proportion of Prescribed Exercise Completed

  Exercise adherence is assessed daily by asking participants to report the proportion of the planned exercise program they completed. The score ranges from 0% to 100%, with higher values indicating a greater proportion of the prescribed exercise completed. The outcome is collected daily for 12 weeks. The prespecified primary analysis includes observations collected during the first 8 weeks; observations from weeks 9-12 are used in secondary/exploratory analyses.

  Daily for 12 weeks.

Secondary Outcomes (8)

• Shoulder Pain and Disability Index (SPADI)

  Baseline and weeks 4, 8, and 12.

• Pain Catastrophizing Scale (PCS)

  Baseline and weeks 4, 8, and 12.

• Fear-Avoidance Beliefs Questionnaire (FABQ)

  Baseline and weeks 4, 8, and 12.

• Pain Self-Efficacy Questionnaire (PSEQ)

  Baseline and weeks 4, 8, and 12.

• EQ-5D-5L Health-Related Quality of Life Index

  Baseline and weeks 4, 8, and 12.

Other Outcomes (5)

• Daily Shoulder Pain During Arm Activity

  Daily for 12 weeks.

• Daily Pain Impact on Sleep

  Daily for 12 weeks.

• Weekly Use of Empowered Relief Audio Materials

  Weekly after the Empowered Relief session until week 12

Study Arms (1)

Exercise Rehabilitation Plus Empowered Relief

EXPERIMENTAL

All participants receive a standardized 12-week exercise-based rehabilitation program and a single 2-hour online Empowered Relief session. The timing of Empowered Relief is randomly assigned for each participant between day 10 and day 26 after initiation of the exercise program, creating staggered baseline periods in the multiple-baseline single-case experimental design.

Behavioral: Empowered Relief; Behavioral: Exercise-Based Rehabilitation

Interventions

Empowered Relief BEHAVIORAL

Empowered Relief is a single 2-hour online pain skills session delivered individually by a certified instructor. The session includes pain education, mindfulness principles, cognitive behavioral skills, and self-regulation strategies. The timing of the session is randomly assigned between day 10 and day 26 after initiation of the exercise-based rehabilitation program, with the actual delivery date allowed to vary by up to 2 days from the assigned date.

Exercise Rehabilitation Plus Empowered Relief

Exercise-Based Rehabilitation BEHAVIORAL

Participants complete a standardized 12-week home-based resistance exercise program for subacromial shoulder pain. The program consists of three individually adapted resistance exercises targeting shoulder external rotation, abduction, and flexion. Participants exercise daily during weeks 1 to 8 and every second day during weeks 9 to 12. The exercises are progressed individually according to the study protocol, with follow-up sessions provided by a study-trained physiotherapist.

Exercise Rehabilitation Plus Empowered Relief

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Copenhagen: lead
• Independent Research Fund Denmark: collaborator
• Aalborg University: collaborator

Study Sites (10)

Ballerup Municipality

Ballerup Municipality, 2750, Denmark

Location

Copenhagen Municipality, Amager Rehabilitation Center

Copenhagen, 2300, Denmark

Location

Frederiksberg Municipality

Frederiksberg, 2000, Denmark

Location

Hvidovre Municipality

Hvidovre, 2650, Denmark

Location

Fredensborg Municipality

Kokkedal, 2980, Denmark

Location

Køge Municipality

Køge, 4600, Denmark

Location

Lolland Municipality

Maribo, 4930, Denmark

Location

Rødovre Municipality

Rødovre Municipality, 2610, Denmark

Location

Høje-Taastrup Municipality

Taastrup, 2630, Denmark

Location

Furesø Municipality

Værløse, 3500, Denmark

Location

Study Officials

• Mikkel Bek Clausen, Phd, Associate professor

  University College Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Bo Jørgensen, PhD

CONTACT

+45 23488716; larj@kp.dk

Mikkel Bek Clausen, Phd, Associate professor

CONTACT

+45 24296384; mibc@kp.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multiple-baseline single-case experimental design across participants. All participants receive the same 12-week exercise-based rehabilitation program and a single 2-hour Empowered Relief session. The timing of the Empowered Relief session is randomly assigned for each participant between day 10 and day 26 after initiation of the exercise program, creating staggered baseline periods. Each participant serves as their own control, with repeated daily outcomes assessed before and after introduction of Empowered Relief.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 28, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

DK (10)