Empowered Relief and Exercise Rehabilitation for People With Subacromial Shoulder Pain

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.

Conditions

• Subacromial Pain Syndrome

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Independent Research Fund Denmark

  collaborator INDUSTRY

• Aalborg University

  collaborator OTHER

• University College Copenhagen

  lead OTHER

Principal Investigators

• Mikkel Bek Clausen, Phd, Associate professor · University College Copenhagen

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• Denmark

Study Locations