The Effect of a Dual-Task Technique-Based Exercise Program on Clinical Outcomes in Rotator Cuff Related Shoulder Pain

Overview

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.

Detailed description

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).

Interventions

• Other Patient Education
  Participants will receive patient education on basic muscle biomechanics, causes of pain, pain management strategies, and proper sleeping positions.
• Other Dual-Task-Based Exercise Therapy
  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
• Other Standard Exercise Therapy
  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 outcome measures

• Numeric Pain Rating Scale (NPRS) [Time frame: At baseline, at week 6, and at week 12]

Secondary outcome measures (4)

• Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) [Time frame: 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]
• Pain Catastrophizing Scale (PCS) [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Istanbul University-Cerrahpasa — Istanbul

Identifiers

NCT: NCT07415967 · 2190016

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗