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

NCT06367998 | Not Yet Recruiting Phase 4

• 1 other identifier: PC24MISV0017
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rotator Cuff Tears; Central Sensitisation; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• The Visual Analogue Scale (VAS) pain score

  Pain score evaluation from 0 to 10, 10 meaning the maximum pain

  Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months

Secondary Outcomes (2)

• Constant shoulder score

  Preoperative, postoperative 6 months and 12 months

• American shouler and elbow surgeons (ASES) score

  Preoperative, postoperative 6 months and 12 months

Study Arms (2)

Pregabalin group

EXPERIMENTAL

Drug: Pregabalin

Control group

NO INTERVENTION

Interventions

Pregabalin DRUG

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

Also known as: Lyrica

Pregabalin group

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead
• Viatris Korea: collaborator

MeSH Terms

Conditions

Rotator Cuff Injuries; Neuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: September 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: August 23, 2024

Record last verified: 2024-08