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.
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.
an existing clinical diagnosis provided by a referring clinician, or
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.
Single group
Empowered Relief
BehavioralEmpowered 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 Rehabilitation
BehavioralParticipants 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.
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 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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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University College Copenhagen
Lead sponsor
Independent Research Fund Denmark
Collaborator
Aalborg University
Collaborator
McGill University
Collaborator
