The Effect of Pregabalin on Shoulder Pain of Patients With Central Sensitization Who Undergo Arthroscopic Rotator Cuff Repair

The Effect of Pregabalin on Shoulder Pain of Patients With Myofascial Pain Syndrome and Central Sensitization Who Undergo Arthroscopic Rotator Cuff Repair

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neuropathic Pain; Rotator Cuff Tears; Central Sensitisation
• Intervention / Treatment: Drug: Pregabalin

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

①Patients aged 19 to under 70 who have been diagnosed with myofascial pain syndrome and are undergoing arthroscopic rotator cuff repair due to a tear of the rotator cuff.

②Patients with central sensitization (Central Sensitization Inventory (CSI) score of 40 or above).

③Patients who understand this study and consent to participate in it.

Exclusion Criteria:

• Patients who are not central sensitization patients (Central Sensitization Inventory (CSI) score of 40 or below)

  • Patients who have previously taken Pregabalin

    • Patients who exhibit hypersensitivity reactions or severe complications after taking Pregabalin.

      • Patients who have been diagnosed with and are being treated for psychiatric disorders ⑤Patients with localized infection, sepsis, or previous neurological abnormalities ⑥Patients with uncontrolled hypertension, evidenced by a resting blood pressure of more than 100 mmHg ⑦Patients with liver function abnormalities (aspartate aminotransferase or alanine aminotransferase >60 IU/litre).

        • Patients with major cardiovascular diseases or renal impairments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Pregabalin group	Drug: Pregabalin; Pregabalin oral intake from the day before surgery to six weeks postoperatively; Other Names: Lyrica

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS pain score	Pain score evaluation	Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant shoulder score	Shoulder functional score	Preoperative, postoperative 6 months and 12 months
American shouler and elbow surgeons (ASES) score	Shoulder functional score	Preoperative, postoperative 6 months and 12 months

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Collaborators: Viatris Korea

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Peripheral Nervous System Diseases; Arthralgia; Rotator Cuff Injuries; Neuralgia; Shoulder Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: PC24MISV0017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No