- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07415967
The Effect of a Dual-Task Technique-Based Exercise Program on Clinical Outcomes in Rotator Cuff Related Shoulder Pain
The aim of this clinical trial is to investigate the effects of a dual-task-based exercise program on clinical outcomes in individuals with rotator cuff-related shoulder pain. The study will evaluate the effects of a dual-task exercise approach, in which physical exercises are performed concurrently with cognitive tasks, on pain, functional status, pain catastrophizing and kinesiophobia. These results will be compared with those of a standard shoulder rehabilitation program. The main questions this study aims to answer are:
- Is there a difference in pain levels between individuals with rotator cuff-related shoulder pain who participate in a dual-task-based exercise program and those who participate in a standard exercise program?
- Is there a difference between these two exercise approaches in terms of shoulder function and psychosocial factors?
Participants will:
- Participate in either a dual-task-based shoulder exercise program or a standard shoulder exercise program twice per week for 6 weeks.
- Undergo clinical assessments at baseline, at week 6, and at week 12.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: İrem Ece İçöz, Bachelor's degree
- Phone Number: 90+ 5511040686
- Email: iremece.icoz@ogr.iuc.edu.tr
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Recruiting
- Istanbul University-Cerrahpaşa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 18 and 65 years
- Diagnosis of impingement syndrome, subacromial bursitis, rotator cuff tendinopathy, or partial rotator cuff tear
- Shoulder pain level ≥3 according to the Numeric Pain Rating Scale (NPRS)
- Shoulder pain persisting for at least 3 months
Exclusion Criteria:
- Diagnosis of shoulder instability, adhesive capsulitis, or full-thickness or massive rotator cuff tear
- Presence of musculoskeletal, neurological, and/or psychological conditions that would prevent participation in an exercise program
- History of shoulder surgery
- Having received physiotherapy or corticosteroid injection treatment for shoulder pain within the past 6 months
- Presence of cognitive impairment that would prevent participation in dual-task exercise activities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dual-Task Technique-Based Exercise Group
Patients will receive a treatment program consisting of patient education and exercise therapy twice per week for a total of 12 sessions.
Exercise sessions will be performed concurrently with cognitive tasks.
|
Participants will receive patient education on basic muscle biomechanics, causes of pain, pain management strategies, and proper sleeping positions.
Participants will be enrolled in a structured exercise program consisting of exercises recommended in the literature.
The program will include a three-phase exercise protocol comprising range of motion exercises, stretching exercises, and strengthening exercises.
In addition to the standard shoulder exercise program, participants will perform concurrent cognitive tasks targeting attention, cognitive processing, working memory, and verbal fluency.
The exercise program will be delivered under the supervision of a physiotherapist twice per week over a 6-week period.
|
|
Active Comparator: Standard Exercise Group
Patients will receive a treatment program consisting of patient education and exercise therapy twice per week for a total of 12 sessions, following a standard shoulder exercise approach.
|
Participants will receive patient education on basic muscle biomechanics, causes of pain, pain management strategies, and proper sleeping positions.
Participants will be enrolled in a structured exercise program consisting of exercises recommended in the literature.
The program will include a three-phase exercise protocol comprising range of motion exercises, stretching exercises, and strengthening exercises.
The exercise program will be delivered under the supervision of a physiotherapist twice per week over a 6-week period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: At baseline, at week 6, and at week 12
|
NPRS will be used to evaluate pain levels.
The scale consists of a numeric rating system ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain."
Participants will be asked to rate the intensity of their shoulder pain.
|
At baseline, at week 6, and at week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)
Time Frame: At baseline, at week 6, and at week 12
|
QuickDASH is an 11-item self-reported questionnaire used to assess the ability to perform specific upper extremity activities.
Participants rate each item on a 5-point Likert scale.
Total scores range from 0 to 100, with higher scores indicating greater functional disability.
|
At baseline, at week 6, and at week 12
|
|
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
Time Frame: At baseline, at week 6, and at week 12
|
ASES is a questionnaire consisting of a patient-reported pain component assessed using a visual analog scale and a functional component including 10 items related to activities of daily living.
The total score ranges from 0 to 100.
Higher scores indicate better functional ability.
|
At baseline, at week 6, and at week 12
|
|
Pain Catastrophizing Scale (PCS)
Time Frame: At baseline, at week 6, and at week 12
|
PCS is a self-reported questionnaire used to assess cognitive processes related to pain.
It consists of 13 items, each rated on a 5-point Likert scale.
Total scores range from 0 to 52.
Higher scores indicate greater levels of pain catastrophizing.
|
At baseline, at week 6, and at week 12
|
|
Tampa Scale of Kinesiophobia-11 (TSK-11)
Time Frame: At baseline, at week 6, and at week 12
|
TSK-11 is the most commonly used shortened version of the Tampa Scale of Kinesiophobia and is used to assess fear of movement or re-injury.
It consists of 11 items, each rated on a 4-point Likert scale.
Total scores range from 11 to 44.
Higher scores indicate greater fear of movement.
|
At baseline, at week 6, and at week 12
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2190016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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