Effect of Pregabalin on Shoulder Pain in Patients With Central Sensitization After Arthroscopic Rotator Cuff Repair

Sponsor
The Catholic University of Korea
Study ID
NCT06367998
Phase
PHASE4
Status
Unknown

Conditions

  • Central Sensitisation
  • Neuropathic Pain
  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
20 Years - 69 Years
Healthy Volunteers
Accepted

Interventions

  • Pregabalin — DRUG
    Pregabalin oral intake from the day before surgery to six weeks postoperatively

Study Details

This study aims to investigate the effects of Pregabalin intake on shoulder pain management in patients with central sensitization undergoing arthroscopic rotator cuff repair. Although Pregabalin is known to be effective in controlling pain after shoulder arthroscopy, research on its efficacy in pain management for patients with central sensitization is scarce. Utilizing a list that identifies central sensitization, this study will explore whether Pregabalin can reduce postoperative pain in these patients and potentially improve joint mobility, emotional, and physical functioning. A prospective randomized study is planned, with inclusion criteria set for patients aged between 19 and 70 who have undergone arthroscopic rotator cuff repair. The study will compare clinical outcomes up to one year postoperatively between two groups of 38 patients each. The case group will receive standard postoperative medications (NSAIDs) plus Pregabalin oral intake from the day before surgery to six weeks postoperatively, while the control group will receive only the standard postoperative medications without Pregabalin.

Key Dates

First listed
Apr 16, 2024
Start date
Sep 1, 2024
Status verified
Aug 2024
Primary completion
May 1, 2025
Completion
May 1, 2026

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Pregabalin group
  • No Intervention: Control group

Primary Outcome Measure

The Visual Analogue Scale (VAS) pain score [ Time Frame: Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months ]

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