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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-05-01

Brief Summary

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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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Detailed Description

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Conditions

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Rotator Cuff Tears Central Sensitisation Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pregabalin group

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

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

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pregabalin

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

Intervention Type DRUG

Other Intervention Names

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Lyrica

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes