Subacromial Pain SyndromePainBehaveNCT07791784
Empowered Relief and Exercise Rehabilitation for People With Subacromial Shoulder Pain
A study testing Empowered Relief and Exercise-Based Rehabilitation in people with Subacromial Pain Syndrome, run by University College Copenhagen at 10 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacromial Pain Syndrome
- What is being tested?
- Empowered Relief and Exercise-Based Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesDenmark
- Study dates
- 2 Sep 2026to Jun 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Denmark10 sites, 10 recruiting
- Recruiting
Ballerup Municipality
Ballerup Municipality, 2750
- Recruiting
Copenhagen Municipality, Amager Rehabilitation Center
Copenhagen, 2300
- Not yet recruiting
Frederiksberg Municipality
Frederiksberg, 2000
- Recruiting
Hvidovre Municipality
Hvidovre, 2650
- Recruiting
Køge Municipality
Køge, 4600
- Recruiting
Fredensborg Municipality
Kokkedal, 2980
- Recruiting
Lolland Municipality
Maribo, 4930
- Recruiting
Rødovre Municipality
Rødovre Municipality, 2610
- Recruiting
Høje-Taastrup Municipality
Taastrup, 2630
- Recruiting
Furesø Municipality
Værløse, 3500
About this study
Official title: Pain, Expectations, Beliefs and Behaviour: Untying the Knot to Guide Care
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:
Read more
- 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.
Read the detailed description
This study uses a multiple-baseline single-case experimental design (SCED) across participants to investigate the effects and mechanisms of a brief pain skills intervention in adults with subacromial shoulder pain.
All participants receive a standardized 12-week exercise-based rehabilitation program. The program consists of individually adapted resistance exercises targeting shoulder external rotation, abduction, and flexion. Participants are instructed to exercise daily during the first 8 weeks and every second day during the final 4 weeks.
In addition to the exercise program, all participants receive a single 2-hour online Empowered Relief session. Empowered Relief includes pain education, mindfulness principles, cognitive behavioral skills, and self-regulation strategies. The session is delivered individually by an instructor certified in the standardized Empowered Relief program.
The timing of Empowered Relief is randomly assigned for each participant between day 10 and day 26 after the start of the exercise program. The actual intervention date may vary by up to 2 days from the assigned date. This creates different baseline periods across participants. Each participant serves as their own control, allowing outcomes before the Empowered Relief session to be compared with outcomes after the session.
Participants answer brief questions every day for 12 weeks. The daily outcome measures represent four predefined domains: pain-related beliefs, expected pain responses to exercise, actual pain responses following exercise, and exercise adherence. In the hypothesised causal model, pain-related beliefs, expected pain responses, and actual pain responses are considered hypothesised intermediate domains, while exercise adherence represents the distal outcome domain. All four domains are assessed using primary daily endpoints.
Following the Empowered Relief session, participants also answer brief weekly questions about their use of the strategies taught during the session. These measures are used to describe engagement with Empowered Relief strategies.
Although daily outcomes are collected for 12 weeks, the prespecified primary SCED analyses use repeated within-person observations collected during the first 8 weeks. This period includes observations both before and after Empowered Relief and represents the time frame most closely connected to the intervention.
The study tests two primary direct-effect hypotheses (H1 and H2) and a predefined set of hypothesised indirect-effect pathways (H3-H7). The direct-effect hypotheses examine whether the introduction of Empowered Relief affects pain-related beliefs and exercise adherence. The indirect-effect hypotheses examine temporal pathways linking Empowered Relief to exercise adherence through the hypothesised intermediate domains of pain-related beliefs, expected pain responses, and actual pain responses.
Main direct-effect hypotheses:
H1: Effect of Empowered Relief on Pain Beliefs Introduction of Empowered Relief will produce a clear and immediate positive change in the level and/or trend of pain beliefs relative to baseline for each participant.
H2: Effect of Empowered Relief on Exercise Adherence Introduction of Empowered Relief will produce a clear and immediate positive change in the level and/or trend of exercise adherence relative to baseline for each participant, controlling for relevant covariates.
Main indirect-effect hypotheses:
H3: Empowered Relief → Pain Beliefs → Exercise Adherence Daily changes in pain beliefs following Empowered Relief will be followed by same-day changes in exercise adherence. Reductions in negative pain beliefs are linked to higher levels of exercise adherence, and vice versa.
H4: Empowered Relief → Pain Beliefs → Expected Pain → Exercise Adherence Daily changes in pain beliefs following Empowered Relief will be followed by same-day changes in expected pain responses, followed by same-day changes in exercise adherence. Reductions in negative pain beliefs are linked to more favourable expected pain responses and higher levels of exercise adherence, and vice versa.
H5: Empowered Relief → Pain Beliefs → Expected Pain → Actual Pain → Exercise Adherence Daily changes in pain beliefs following Empowered Relief will be followed by same-day changes in expected pain responses, followed by same-day changes in actual pain responses, followed by next-day changes in exercise adherence. Reductions in negative pain beliefs are linked to more favourable expected and actual pain responses and higher levels of exercise adherence, and vice versa.
H6: Empowered Relief → Pain Beliefs → Actual Pain → Exercise Adherence Daily changes in pain beliefs following Empowered Relief will be followed by same-day changes in actual pain responses, followed by next-day changes in exercise adherence. Reductions in negative pain beliefs are linked to more favourable actual pain responses and higher levels of exercise adherence, and vice versa.
H7: Empowered Relief → Pain Beliefs → Actual Pain → Expected Pain → Exercise Adherence Daily changes in pain beliefs following Empowered Relief will be followed by same-day changes in actual pain responses, followed by next-day changes in expected pain responses, followed by same-day changes in exercise adherence. Reductions in negative pain beliefs are linked to more favourable actual and expected pain responses and higher levels of exercise adherence, and vice versa.
Additional exploratory analyses:
In addition to testing H1-H7, the same daily outcome measures will be used in exploratory analyses of direct effects of Empowered Relief on expected and actual pain responses and to explore additional temporal relationships between the daily outcome domains.
Sample size:
We plan to include a total of 30 participants with sufficient data to be included in the primary analyses. Sufficient data are defined as no more than 20% missing observations across the daily assessments during weeks 1-8, providing a minimum of 45 observations per participant during the time frame most closely connected to the change in phase. Enrolment is planned to continue until 30 participants have provided sufficient data to be included in the primary analyses, and is hence expected to differ from the anticipated number of participants (n=60) described in the Enrolment Section.
- Conditions
- Subacromial Pain Syndrome
- Being tested
- Empowered Relief, Exercise-Based Rehabilitation
- Keywords
- Subacromial Shoulder Pain, Pain Catastrophizing, Exercise Adherence, Empowered Relief, Exercise Therapy, Rehabilitation, Pain Self-Efficacy, Single-Case Experimental Design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered ReliefBehavioural
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-Based RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Empowered Relief; Behavioral: Exercise-Based Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily for 12 weeks.
Secondary outcomes (8)
Shoulder Pain and Disability Index (SPADI)
Shoulder pain and disability are assessed using the Danish version of the Shoulder Pain and Disability Index (SPADI). The questionnaire provides a total score from 0 to 100, with higher scores indicating greater shoulder-related pain and disability.
Measured: Baseline and weeks 4, 8, and 12.
Pain Catastrophizing Scale (PCS)
Pain catastrophizing is assessed using the Danish version of the 13-item Pain Catastrophizing Scale (PCS). The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.
Measured: Baseline and weeks 4, 8, and 12.
Fear-Avoidance Beliefs Questionnaire (FABQ)
Fear-avoidance beliefs are assessed using the 16-item Fear-Avoidance Beliefs Questionnaire (FABQ), adapted to the shoulder region. The total score ranges from 0 to 96, with higher scores indicating greater fear-avoidance beliefs.
Measured: Baseline and weeks 4, 8, and 12.
Pain Self-Efficacy Questionnaire (PSEQ)
Pain self-efficacy is assessed using the Danish version of the 10-item Pain Self-Efficacy Questionnaire (PSEQ). The total score ranges from 0 to 60, with higher scores indicating greater confidence in performing activities despite pain.
Measured: Baseline and weeks 4, 8, and 12.
EQ-5D-5L Health-Related Quality of Life Index
Health-related quality of life is assessed using the EQ-5D-5L. Responses across the five EQ-5D dimensions are used to derive an EQ-5D index score, with higher values indicating better health-related quality of life.
Measured: Baseline and weeks 4, 8, and 12.
EQ-5D-5L Visual Analogue Scale (EQ-5D VAS)
Health-related quality of life is assessed using the EQ-5D-5L Visual Analogue Scale. Participants rate their overall health on a scale from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health.
Measured: Baseline and weeks 4, 8, and 12.
Global Impression of Change (GIC)
Global impression of change is assessed using a 7-point Likert scale ranging from "Much better, an important improvement" to "Much worse, an important aggravation."
Measured: Weeks 4, 8, and 12.
Patient Acceptable Symptom State (PASS)
Patient acceptable symptom state is assessed using a standardized yes/no question asking whether the participant considers the current state of their shoulder symptoms acceptable.
Measured: Weeks 4, 8, and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start2 Sep 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Pain SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Independent Research Fund Denmark, Aalborg University, McGill University
- Responsible party
- Sponsor
- Investigators
- Mikkel Bek Clausen, Phd, Associate professor, Principal investigator, University College Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791784
- Sponsor's protocol ID
- Alias: 200938
- Other IDs
- 10.46540/4308-00113B
- Acronym
- PainBehave
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided