The Effect of a Dual-Task Technique-Based Exercise Program on Clinical Outcomes in Rotator Cuff Related Shoulder Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstanbul University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Patient Education
Other interventionParticipants will receive patient education on basic muscle biomechanics, causes of pain, pain management strategies, and proper sleeping positions.
Dual-Task-Based Exercise Therapy
Other interventionParticipants 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.
Standard Exercise Therapy
Other interventionParticipants 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.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Dual-Task Technique-Based Exercise GroupExperimental treatment 2 interventions
Group B: Standard Exercise GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Numeric Pain Rating Scale (NPRS)
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.
Time frame
At baseline, at week 6, and at week 12Secondary outcomes
1
Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)
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.
Time frame
At baseline, at week 6, and at week 122
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
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.
Time frame
At baseline, at week 6, and at week 123
Pain Catastrophizing Scale (PCS)
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.
Time frame
At baseline, at week 6, and at week 124
Tampa Scale of Kinesiophobia-11 (TSK-11)
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.
Time frame
At baseline, at week 6, and at week 12Sponsors and contacts
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Istanbul University
Lead sponsor
Istanbul University - Cerrahpasa
Sponsor institution
Source ClinicalTrials.gov