Shoulder PainNCT07481864
The Effect of Early-Phase Graded Motor Imagery Following Massive Rotator Cuff Repair.
A study testing Graded Motor İmagery in people with Shoulder Pain, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Graded Motor İmagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30 and 65 years
- Presence of an arthroscopically repaired anterior-superior rotator cuff tear, involving the supraspinatus and subscapularis tendons
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem University
Istanbul, Turkey, +90
Nuray ALACA, 05324251290, nuray.alaca@acibadem.edu.tr
About this study
Official title: The Effect of Early-Phase Graded Motor Imagery Following Massive Rotator Cuff Repair
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.
- Conditions
- Shoulder Pain
- Being tested
- Graded Motor İmagery
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded Motor İmageryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Graded Motor İmagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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."
Measured: 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.
Measured: 4 weeks, 6 weeks, and 12 weeks after surgery.
Secondary outcomes (5)
Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a self-reported questionnaire consisting of pain (5 items) and disability (8 items) subscales. Scores range from 0 to 100, with higher scores indicating greater pain and functional limitation.
Measured: 6 weeks and 12 weeks after surgery.
Motor Imagery Ability (VMIQ-2)
Motor imagery ability will be evaluated using the Vividness of Movement Imagery Questionnaire-2 (VMIQ-2), which assesses internal visual imagery, external visual imagery, and kinesthetic imagery across 36 items. Lower scores indicate more vivid imagery ability.
Measured: Baseline (postoperative day 0), 6 weeks, and 12 weeks.
Tampa Scale of Kinesiophobia (TSK)
The Tampa Scale of Kinesiophobia evaluates fear of movement related to pain. Scores range from 17 to 68, with higher scores indicating greater fear of movement.
Measured: Baseline (postoperative day 0), 6 weeks, and 12 weeks.
Pain Catastrophizing Scale (PCS)
The PCS assesses catastrophic thinking related to pain across 13 items. Total scores range from 0 to 52, with higher scores indicating greater catastrophizing.
Measured: Baseline (postoperative day 0), 6 weeks, and 12 weeks.
Pain Self-Efficacy Questionnaire (PSEQ)
The PSEQ measures confidence in performing activities despite pain. Scores range from 0 to 60, with higher scores indicating greater self-efficacy.
Measured: Baseline (postoperative day 0), 6 weeks, and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start15 Mar 2026
- Primary completion1 Jun 2026
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray Alaca, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481864
- Sponsor's protocol ID
- 2025-10-384
- Status last verified
- Jul 2026
- First submitted
- 16 Mar 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early-Phase Graded Motor Imagery Following Massive Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT07481864
- Acronym / sponsor ID
- 2025-10-384
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabilitation Program | Active comparator | Other: Graded Motor İmageryParticipants 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. |
| Graded motor imagery | Experimental | Other: Graded Motor İmageryParticipants 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 30 and 65 years
- Presence of an arthroscopically repaired anterior-superior rotator cuff tear, involving the supraspinatus and subscapularis tendons
Key exclusion criteria (7 listed)
- Age younger than 30 years or older than 65 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graded Motor İmageryThe 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 | Conventional Rehabilitation Program, Graded motor imagery |
Primary outcome
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.
5 secondary outcomes
Shoulder Pain and Disability Index (SPADI)
Time frame: 6 weeks and 12 weeks after surgery.
Motor Imagery Ability (VMIQ-2)
Time frame: Baseline (postoperative day 0), 6 weeks, and 12 weeks.
Tampa Scale of Kinesiophobia (TSK)
Time frame: Baseline (postoperative day 0), 6 weeks, and 12 weeks.
Pain Catastrophizing Scale (PCS)
Time frame: Baseline (postoperative day 0), 6 weeks, and 12 weeks.
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Baseline (postoperative day 0), 6 weeks, and 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded Motor İmagery in people with Shoulder Pain, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nuray ALACA (05324251290, nuray.alaca@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Numeric Rating Scale, NRS) (time frame: Baseline (postoperative day 0), 2 weeks, 4 weeks, 6 weeks, and 12 weeks after surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.