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NCT Number: 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.

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Key information

Conditions

Rotator Cuff Related Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Shoulder Pain Syndrome Signs and Symptoms Subacromial Pain Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location status: Recruiting

About this study

A total of 46 patients will be included in the study based on the results of a power analysis. Participants will be randomly allocated into two groups using a computer-based randomization program: the Dual-Task Technique-Based Exercise Group (Group 1) and the Standard Exercise Group (Group 2). Both groups will receive patient education and participate in a supervised exercise program. In the Dual-Task Technique-Based Exercise Group, exercise sessions will be performed concurrently with cognitive tasks. The Standard Exercise Group will undergo a standard shoulder exercise program without cognitive task integration. The intervention will be administered twice per week for a total of 12 sessions over a 6-week period. Clinical assessments will be conducted for both groups at baseline (before treatment), at the end of the intervention (week 6), and at week 12 as a follow-up assessment. The primary outcome measure will be pain intensity, assessed using the Numeric Pain Rating Scale (NPRS). Secondary outcome measures will include the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (Q-DASH), the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), the Pain Catastrophizing Scale (PCS) and the Tampa Scale of Kinesiophobia-11 (TSK-11).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Education

Other

Participants will receive patient education on basic muscle biomechanics, causes of pain, pain management strategies, and proper sleeping positions.

Dual-Task-Based Exercise Therapy

Other

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.

Standard Exercise Therapy

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

İrem Ece İçöz, Bachelor's degree

CONTACT

[email protected]

90+ 5511040686

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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