Empowered Relief and Exercise Rehabilitation for People With Subacromial Shoulder Pain

Condition(s) studied

Investigational drug(s) / intervention(s)

Empowered Relief: 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 Rehabilitation: 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 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.

Eligibility

Primary outcome measure(s)

• Daily Pain Catastrophizing — 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.
• Daily Fear Avoidance — 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.
• Daily Pain Self-Efficacy — 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.
• Daily Expected Pain Intensity — 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.
• Daily Expected Duration of Pain Aggravation — 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.
• Daily Expected Change in Symptoms — 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.
• Daily Actual Pain Intensity — 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.
• Daily Actual Duration of Pain Aggravation — 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.
• Daily Actual Change in Symptoms — 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.
• Daily Time Spent on Exercise Program — 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.
• Daily Proportion of Prescribed Exercise Completed — 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.

Trial sites (10)

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