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

Phase 4

Not yet recruiting

• Conditions: Central Sensitisation; Neuropathic Pain; Rotator Cuff Tears
• Interventions: Drug: Pregabalin

• Registration Number: NCT06367998
• Lead Sponsor: The Catholic University of Korea

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Study Start: 2024-09-01
• Primary Completion: 2025-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Age over 19 to under 70
• Underwent arthroscopic rotator cuff repair due to a tear of the rotator cuff.
• Clinical diagnosis of myofascial pain syndrome
• Central sensitization (Central Sensitization Inventory (CSI) score of 40 or above).

Exclusion Criteria

• Previous history of Pregabalin prescription
• Hypersensitivity reactions or severe complications after taking Pregabalin.
• Diagnosed with and are being treated for psychiatric disorders
• Localized infection, sepsis, or previous neurological abnormalities
• Uncontrolled hypertension (evidenced by a resting blood pressure of more than 100 mmHg)
• Liver function abnormalities (aspartate aminotransferase or alanine aminotransferase >60 IU/litre).
• major cardiovascular diseases or renal impairments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin group	Pregabalin	-

Primary Outcome Measures

Name	Time	Method
The Visual Analogue Scale (VAS) pain score	Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months	Pain score evaluation from 0 to 10, 10 meaning the maximum pain

Secondary Outcome Measures

Name	Time	Method
Constant shoulder score	Preoperative, postoperative 6 months and 12 months	Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function
American shouler and elbow surgeons (ASES) score	Preoperative, postoperative 6 months and 12 months	Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function