NCT07415967

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Feb 2026Jun 2027

First Submitted

Initial submission to the registry

February 10, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 16, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

February 10, 2026

Last Update Submit

April 15, 2026

Conditions

Keywords

Rotator cuffShoulder painDual-task exercise

Outcome Measures

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.

    At baseline, at week 6, and at week 12

Secondary Outcomes (4)

  • Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)

    At baseline, at week 6, and at week 12

  • The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)

    At baseline, at week 6, and at week 12

  • Pain Catastrophizing Scale (PCS)

    At baseline, at week 6, and at week 12

  • Tampa Scale of Kinesiophobia-11 (TSK-11)

    At baseline, at week 6, and at week 12

Study Arms (2)

Dual-Task Technique-Based Exercise Group

EXPERIMENTAL

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.

Other: Patient EducationOther: Dual-Task-Based Exercise Therapy

Standard Exercise Group

ACTIVE COMPARATOR

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.

Other: Patient EducationOther: Standard Exercise Therapy

Interventions

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

Dual-Task Technique-Based Exercise GroupStandard Exercise Group

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.

Dual-Task Technique-Based Exercise Group

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.

Standard Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

İrem Ece İçöz, Bachelor's degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 17, 2026

Study Start

February 16, 2026

Primary Completion (Estimated)

February 16, 2027

Study Completion (Estimated)

June 16, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations