Pain Education After Rotator Cuff Surgery

Study acronym: PNE-RCS
StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Minor Trial completed Show 4 more changesShow less
    • Final enrollment: 52 participants (planned 45)
    • Primary and study completion dates changed from estimate of Sep 30, 2026 to Sep 29, 2026
    • Secondary endpoints: details revised at 5 of 6 entries
    • Site details revised
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  4. Minor Eligibility criteria shortened, about 79 words
    • Secondary endpoints: details revised at 5 of 6 entries
    • Collaborators: 2 to 1
    v2
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06886932
Lead Sponsor Elif Dilara Durmaz
Collaborators: Karaman Training and Research Hospital
Conditions
(from sponsor)
Rotator Cuff Tears, Postoperative Pain Management, Shoulder Dysfunction, Kinesiophobia (Fear of Movement), Postoperative Rehabilitation
Related terms Kinesiophobia, Rotator Cuff Injuries
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov