An interventional study of Empowered Relief and Exercise-Based Rehabilitation in Subacromial Pain Syndrome, sponsored by University College Copenhagen. Recruiting at 10 sites in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University College Copenhagen · Not applicable, Interventional, and Treatment
Among 268 studies in Pain with a site in Denmark — 37 open to participants now, 43 under way, none of them phase 3. Pain · Denmark.
Among the 268 studies in Pain with a site in Denmark, this one is the 111th largest by planned enrollment of the 215 interventional ones that give a count, is one of 12 that started in 2026, is one of 134 with no phase, reaches primary completion later than 26 of the 42 other live ones, and was the 265th registered.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
Browse Pain studies →37 of the 268 studies in Pain with a site in Denmark are open now. Recruiting first, the newest first:
Danish Headache Center · Sites in Denmark
Aalborg University · Sites in Denmark
University of Aarhus · Sites in Denmark
Aalborg University · Sites in Denmark
Aalborg University · Sites in Denmark
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
268 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 24 · Phase 3 27 · Phase 4 28
First in 2002; this study’s year is marked. 12 started in 2026.
This study's planned enrollment of 60 is close to the median of 66 across 8,493 interventional studies indexed under Pain.
Median enrollment 64 across the 215 interventional studies, 100 across the 53 observational. Of the 197 that completed or were terminated, 17 (9%) have results posted.
This tab as a report to print or save as PDF → With an account.
37 of 268 have an industry lead sponsor. The 10 most frequent:
University College Copenhagen is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
University College Copenhagen has 1 study filed under Pain — fewer than ten, so there is no comparison to draw.
12 of the studies in Pain with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06833749KeyBioscience AGEfficacy and Safety of KBP-336 in Obese Individuals with Osteoarthritis | 2026-11 |
| NCT06678217Copenhagen University Hospital, HvidovreDetection of Electrodermal Activity in Pain 1 | 2026-12-01 |
| NCT06677593Copenhagen University Hospital, HvidovreDetection of Electrodermal Activity in Pain 2 | 2026-12-01 |
| NCT07110324Rigshospitalet, DenmarkCharacteristics of Persistent Pain Composition Following Total Hip or Knee Arthroplasty: a Descriptive Study | 2026-12-01 |
| NCT06257862Aarhus University HospitalTranslation, Cross-cultural Validity and Reliability of a Danish Version of the Anterior Knee Pain Scale | 2026-12-31 |
Among the 268 studies in Pain with a site in Denmark, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Daily for 12 weeks.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 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.
Time frame: Weeks 4, 8, and 12.
Daily Shoulder Pain During Arm Activity
Shoulder symptom level is assessed daily using a single question about pain during arm activity. Pain is scored from 0 to 10, with higher scores indicating greater shoulder pain during activity.
Time frame: Daily for 12 weeks.
Daily Pain Impact on Sleep
Pain impact on sleep is assessed daily using the sleep item from the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH). The item is scored from 1 to 5, with higher scores indicating greater impact of shoulder pain on sleep.
Time frame: Daily for 12 weeks.
Weekly Use of Empowered Relief Audio Materials
Engagement with Empowered Relief is assessed weekly by asking participants about their use of the intervention's audio materials. This measure is used as a process indicator of engagement with the Empowered Relief strategies.
Time frame: Weekly after the Empowered Relief session until week 12
Weekly Use of Cognitive Reframing
Engagement with Empowered Relief is assessed weekly by asking participants about their use of cognitive reframing of unhelpful pain-related thoughts. This measure is used as a process indicator of engagement with the Empowered Relief strategies.
Time frame: Weekly after the Empowered Relief session until week 12
Weekly Use of Self-Soothing Strategies
Engagement with Empowered Relief is assessed weekly by asking participants about their use of self-soothing strategies. This measure is used as a process indicator of engagement with the Empowered Relief strategies.
Time frame: Weekly after the Empowered Relief session until week 12
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jun 2027, 9 months after the start.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 9 months is close to that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Oct 13, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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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University College Copenhagen