NCT06886932 Pain Education After Rotator Cuff Surgery
| NCT ID | NCT06886932 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Elif Dilara Durmaz |
| Condition | Rotator Cuff Tears |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2025-04-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Study Title: The Effect of Pain Neuroscience Education Combined with Conventional Rehabilitation on Pain Management and Functional Outcomes in Patients Undergoing Mini-Open Rotator Cuff Repair Purpose: This study aims to investigate whether adding Pain Neuroscience Education (PNE) to a conventional rehabilitation program improves pain management, physical function, and psychosocial outcomes in patients who have undergone mini-open surgery for rotator cuff tears (RCT). The study will also compare the effects of PNE when delivered before versus after surgery. Who Can Participate: Adults aged 40-75 who have been diagnosed with a medium-sized rotator cuff tear and are scheduled for mini-open surgical repair. Participants must meet specific health criteria and be willing to participate in the rehabilitation program. Study Details: Participants will be randomly assigned to one of three groups: Group 1: Conventional rehabilitation only. Group 2: Conventional rehabilitation + PNE before surgery. Group 3: Conventional rehabilitation + PNE after surgery. PNE involves educational sessions that explain the biology of pain, how the nervous system processes pain, and strategies to reduce fear and catastrophizing related to pain. The study will last approximately 12 weeks, with regular assessments of pain levels, physical function, and psychosocial factors (e.g., fear of movement, depression, sleep quality). Potential Benefits: Participants may experience reduced pain, improved shoulder function, and better overall recovery. The study may provide valuable insights into how PNE can enhance rehabilitation outcomes for patients with rotator cuff tears. Potential Risks: Some participants may find the educational sessions time-consuming or mentally challenging. There is a small risk of discomfort during physical assessments or rehabilitation exercises. Why is this study important?: Rotator cuff tears are a common cause of shoulder pain and disability, especially in older adults. Post-surgical pain and fear of movement can slow recovery and reduce quality of life. This study will help determine whether PNE, when combined with conventional rehabilitation, can improve recovery outcomes and provide a better understanding of how timing (before or after surgery) affects its effectiveness.
Eligibility Criteria
Eligibility Criteria Inclusion Criteria: Diagnosis of a medium-sized rotator cuff tear (1-3 cm) confirmed by Magnetic Resonance Imaging (MRI) and scheduled for surgical repair Age between 40 and 75 years Sufficient Turkish language proficiency to understand and complete the informed consent form and assessment scales Mini-Mental State Examination (MMSE) score ≥ 24, indicating adequate cognitive function for study participation Exclusion Criteria: Corticosteroid injection received within the last 6 weeks Adhesive capsulitis, defined as loss of passive external rotation greater than 50% or 30° History of previous cervical, thoracic, or shoulder surgery Presence of cervical radiculopathy, characterized by pain and tingling radiating to the arm due to nerve root involvement Acromioclavicular joint pathology or shoulder instability causing shoulder pain Full-thickness rotator cuff tear Calcific tendinitis Systemic diseases (e.g., inflammatory arthritis, malignancy) or neurological disorders (e.g., fibromyalgia, other neurological deficits) Fracture, labral lesion, or biceps tendon injury in the affected shoulder Prior participation in a chronic pain psychological management program or presence of generalized body pain
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06886932 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Rotator Cuff Tears. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06886932 currently recruiting?
Yes, NCT06886932 is actively recruiting participants. Contact the research team at elifdilaradurmaz@gmail.com for enrollment information.
Where is the NCT06886932 trial being conducted?
This trial is being conducted at Karaman, Turkey (Türkiye).
Who is sponsoring the NCT06886932 clinical trial?
NCT06886932 is sponsored by Elif Dilara Durmaz. The trial plans to enroll 45 participants.