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Clinical Trials/NCT07481864
NCT07481864RecruitingNot Applicable

The Effect of Early-Phase Graded Motor Imagery Following Massive Rotator Cuff Repair

Acibadem University1 site in 1 country38 target enrollmentStarted: March 15, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
38
Locations
1
Primary Endpoint
Pain Intensity (Numeric Rating Scale, NRS)

Study Overview

Brief Summary

Massive rotator cuff tears are associated with significant pain, functional limitations, and prolonged rehabilitation following surgical repair. In the early postoperative phase, rehabilitation protocols are often limited due to surgical protection requirements, which may delay the restoration of motor control and shoulder function. Graded motor imagery (GMI), a movement representation technique that includes laterality recognition, motor imagery, and mirror therapy, has been shown to modulate cortical processing and improve pain and motor function in various musculoskeletal and neurological conditions. However, its potential role in early postoperative shoulder rehabilitation has not been adequately investigated.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age between 30 and 65 years
  • Presence of an arthroscopically repaired anterior-superior rotator cuff tear, involving the supraspinatus and subscapularis tendons

Exclusion Criteria

  • Age younger than 30 years or older than 65 years
  • Presence of severe malignant, hematological, endocrine, metabolic, rheumatologic, or gastrointestinal diseases
  • Diagnosis of glenohumeral osteoarthritis (Kellgren-Lawrence grade III or higher, with radiographic evidence of osteophytes)
  • Current treatment with cytotoxic agents or systemic corticosteroids
  • Alcohol dependence, history of substance abuse, or psychological/emotional disorders that may compromise the validity of informed consent
  • Previous surgery on the ipsilateral shoulder
  • Multiple tendon tears, such as combined tears involving the supraspinatus together with the infraspinatus or subscapularis tendons

Outcomes

Primary Outcomes

Pain Intensity (Numeric Rating Scale, NRS)

Time Frame: Baseline (postoperative day 0), 2 weeks, 4 weeks, 6 weeks, and 12 weeks after surgery.

Pain intensity will be assessed using the Numeric Rating Scale (NRS), where participants rate their average shoulder pain over the past 24 hours on a scale from 0 (no pain) to 10 (worst imaginable pain). Pain will be evaluated at rest, during activity, and at night.

Subjective Shoulder Value (SSV)

Time Frame: Baseline (postoperative day 0), 2 weeks, 4 weeks, 6 weeks, and 12 weeks.

Participants will rate the overall function of their shoulder on a 10-cm scale ranging from "as bad as it could be" to "as good as it could be."

Passive Shoulder Range of Motion

Time Frame: 4 weeks, 6 weeks, and 12 weeks after surgery.

Passive shoulder range of motion will be measured using a goniometer.

Secondary Outcomes

  • Shoulder Pain and Disability Index (SPADI)(6 weeks and 12 weeks after surgery.)
  • Motor Imagery Ability (VMIQ-2)(Baseline (postoperative day 0), 6 weeks, and 12 weeks.)
  • Tampa Scale of Kinesiophobia (TSK)(Baseline (postoperative day 0), 6 weeks, and 12 weeks.)
  • Pain Catastrophizing Scale (PCS)(Baseline (postoperative day 0), 6 weeks, and 12 weeks.)
  • Pain Self-Efficacy Questionnaire (PSEQ)(Baseline (postoperative day 0), 6 weeks, and 12 weeks.)

Investigators

Sponsor
Acibadem University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nuray Alaca

Assoc. Prof. Nuray Alaca

Acibadem University

Study Sites (1)

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