Actively Recruiting

Age: 40Years - 75Years
All Genders
NCT06886932

Pain Education After Rotator Cuff Surgery

Led by Elif Dilara Durmaz · Updated on 2026-04-22

45

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

E

Elif Dilara Durmaz

Lead Sponsor

K

Karaman Training and Research Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pain Education After Rotator Cuff Surgery

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of a medium-sized rotator cuff tear (1-3 cm) confirmed by MRI and scheduled for surgery
  • Age between 40 and 75 years
  • Sufficient Turkish language skills to understand consent and assessments
  • Mini-Mental State Examination (MMSE) score of 24 or higher indicating adequate cognitive function
Not Eligible

You will not qualify if you...

  • Corticosteroid injection within the last 6 weeks
  • Adhesive capsulitis with loss of passive external rotation over 50% or 30 degrees
  • Previous cervical, thoracic, or shoulder surgery
  • Cervical radiculopathy causing arm pain and tingling
  • Acromioclavicular joint problems or shoulder instability causing pain
  • Full-thickness rotator cuff tear
  • Calcific tendinitis
  • Systemic diseases like inflammatory arthritis or cancer
  • Neurological disorders such as fibromyalgia or other deficits
  • Fracture, labral lesion, or biceps tendon injury in the affected shoulder
  • Prior participation in chronic pain psychological management or generalized body pain

AI-Screening

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Trial Site Locations

Total: 1 location

1

Karaman Training and Research Hospital

Karaman, Turkey (Türkiye)

Actively Recruiting

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Research Team

E

Elif Dilara DURMAZ, MSc, Specialist Physiotherapis

CONTACT

A

Aynur BAŞARAN, Professor, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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