Pain Education After Rotator Cuff Surgery

NCT06886932 | Recruiting

• 1 other identifier: IstinyeRCT2025
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears; Postoperative Pain Management; Shoulder Dysfunction; Kinesiophobia (Fear of Movement); Postoperative Rehabilitation

Keywords

Pain Neuroscience Education; Postoperative Rehabilitation; Rotator Cuff Tear; Kinesiophobia; Shoulder Surgery Outcomes; Postoperative Pain Management

Outcome Measures

Primary Outcomes (3)

• Pain Intensity

  Description: Pain intensity will be measured using the Numeric Analog Scale (NAS). Patients will rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable). Pain intensity will be measured using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent worse outcomes.

  Time Frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).

• Pressure Pain Threshold (PPT)

  PPT will be measured using a digital algometer to assess changes in pain sensitivity at the shoulder region. This measures the minimum pressure required to elicit pain.

  2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).

• Conditioned Pain Modulation (CPM)

  CPM will be evaluated to assess the efficiency of the endogenous pain modulation system. This measures the body's ability to modulate pain through conditioned stimuli.

  2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).

Secondary Outcomes (6)

• Kinesiophobia (Fear of Movement)

  2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).

• Sleep Quality

  2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).

• Depression and Anxiety

  2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).

• Shoulder Functionality

  2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).

• Modified Constant-Murley Shoulder Score (MCOS)

  2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).

Other Outcomes (2)

• Postural Alignment

  2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).

• Muscle Elastography

  2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).

Study Arms (3)

ANE + Rehabilitation (Preoperative)

Patients in this group will receive Pain Neuroscience Education (ANE) before surgery, combined with a conventional rehabilitation program. The ANE will include education on pain mechanisms, neurophysiology, and the role of the central nervous system in pain perception. The conventional rehabilitation program will consist of exercises, manual therapy, and functional training tailored to rotator cuff repair recovery.

ANE + Conventional Rehabilitation (Postoperative)

Patients in this group will receive Pain Neuroscience Education (ANBE) after surgery, combined with a conventional rehabilitation program. The ANBE will focus on reducing pain catastrophizing, anxiety, and kinesiophobia, while the rehabilitation program will include postoperative exercises, mobility training, and strength-building activities.

Conventional Rehabilitation Only (Control Group)

Patients in this group will receive only the conventional rehabilitation program without any additional Pain Neuroscience Education. The rehabilitation program will include standard postoperative exercises, mobility training, and strength-building activities, as per the clinical guidelines for rotator cuff repair recovery

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of adult patients aged 40-75 years who have been diagnosed with a medium-sized rotator cuff tear (1-3 cm) confirmed by Magnetic Resonance Imaging (MRI) and are scheduled for surgical repair using the mini-open surgical technique. Participants must meet the following inclusion criteria: Ability to understand and complete the informed consent form and related assessment scales in Turkish. A score of 24 or higher on the Mini-Mental State Examination (MMSE) to ensure adequate cognitive function for participation. Patients will be excluded if they have: Received a corticosteroid injection within the last 6 weeks. Evidence of adhesive capsulitis (loss of passive external rotation greater than 50% or 30°). A history of prior cervical, thoracic, or shoulder surgery. Cervical radiculopathy, acromioclavicular pathology, shoulder instability, or a full-thickness rotator cuff tear. Calcific tendinitis, systemic diseases (e.g., inflammatory arthritis, malignancy), o

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elif Dilara Durmaz: lead
• Karaman Training and Research Hospital: collaborator

Study Sites (1)

Karaman Training and Research Hospital

Karaman, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries; Kinesiophobia

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Phobic Disorders; Anxiety Disorders; Mental Disorders

Central Study Contacts

Elif Dilara DURMAZ, MSc, Specialist Physiotherapis

CONTACT

+90 5072367034; elifdilaradurmaz@gmail.com

Aynur BAŞARAN, Professor, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: invenstigator

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: End Date: The date when access to the data will be closed. Typically, this could be a period after the data has been shared, such as a few years after the study completion.
• Access Criteria: Access will be provided through a secure, controlled-access platform (e.g., \[insert platform name, e.g., ClinicalStudyDataRequest.com\]). Researchers will need to submit a formal request and provide a research proposal. Access will be granted after approval by an independent data access committee and once a data use agreement has been signed.

Locations

TU (1)