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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06367998
Other study ID # PC24MISV0017
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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