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

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06367998

Enrollment

Registered

2024-04-16

Start date

2024-09-01

Completion date

2026-05-01

Last updated

2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Sensitisation, Neuropathic Pain, Rotator Cuff Tears

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.

Interventions

DRUGPregabalin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 69 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The Visual Analogue Scale (VAS) pain score	Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months	Pain score evaluation from 0 to 10, 10 meaning the maximum pain

Secondary

Measure	Time frame	Description
Constant shoulder score	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	Preoperative, postoperative 6 months and 12 months	Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026