Effect of Pregabalin on Shoulder Pain in Patients With Central Sensitization After 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.

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Key information

Conditions

Rotator Cuff Tears Central Sensitisation Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Rotator Cuff Injuries Rupture Shoulder Injuries Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

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

Other names: Lyrica

Primary outcomes

The Visual Analogue Scale (VAS) pain score

Time frame: Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months

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

Secondary outcomes

Constant shoulder score

Time frame: 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

Time frame: Preoperative, postoperative 6 months and 12 months

Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Collaborators

Viatris Korea

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Apr 16, 2024
Registry last updated: Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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