NCT Number: NCT07791784
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Ballerup Municipality, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Daily for 12 weeks.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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: Baseline and weeks 4, 8, and 12.
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 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 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 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.
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.
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: Weeks 4, 8, and 12.
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 is assessed using a standardized yes/no question asking whether the participant considers the current state of their shoulder symptoms acceptable.
Time frame: Daily for 12 weeks.
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.
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: Weekly after the Empowered Relief session until week 12
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
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
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.
Contact information is provided by the study sponsor or research team.
Lars Bo Jørgensen, PhD
CONTACT
Mikkel Bek Clausen, Phd, Associate professor
CONTACT
University College Copenhagen
Other
Pain, Expectations, Beliefs and Behaviour: Untying the Knot to Guide Care
Acronym: PainBehave
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