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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06367998
• Other study ID #: PC24MISV0017
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: May 1, 2026

Study information

• Verified date: May 2024
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Sensitisation
• Neuralgia
• Neuropathic Pain
• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Catholic University of Korea	Viatris Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Constant shoulder score	Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function	Preoperative, postoperative 6 months and 12 months
Secondary	American shouler and elbow surgeons (ASES) score	Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function	Preoperative, postoperative 6 months and 12 months