NCT07481864

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Aug 2026

Shorter than P25 for not_applicable

Status
not yet 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

First Submitted

Initial submission to the registry

March 16, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

August 15, 2026

Expected
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

15 days

First QC Date

March 16, 2026

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain Intensity (Numeric Rating Scale, NRS)

    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.

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

  • Subjective Shoulder Value (SSV)

    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."

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

  • Passive Shoulder Range of Motion

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

    4 weeks, 6 weeks, and 12 weeks after surgery.

Secondary Outcomes (5)

  • 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.

Study Arms (2)

Conventional Rehabilitation Program

ACTIVE COMPARATOR

Participants will receive a conventional postoperative rehabilitation program following massive rotator cuff repair. The program will include standard physiotherapy interventions such as protected passive range-of-motion exercises, gradual progression to active-assisted and active exercises, scapular stabilization exercises, and pain management strategies according to the early postoperative rehabilitation protocol.

Other: Graded Motor İmagery

Graded motor imagery

EXPERIMENTAL

Participants in the experimental group will receive the conventional rehabilitation program in addition to a graded motor imagery intervention. The graded motor imagery program will include laterality recognition training, motor imagery exercises, and mirror therapy tasks aimed at activating cortical motor networks without physical shoulder movement during the early postoperative phase.

Other: Graded Motor İmagery

Interventions

The graded motor imagery program will include laterality recognition training, motor imagery exercises, and mirror therapy tasks aimed at activating cortical motor networks without physical shoulder movement during the early postoperative phase.

Conventional Rehabilitation ProgramGraded motor imagery

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 19, 2026

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03