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

August 21, 2024 updated by: Hyungsuk Kim, The Catholic University of Korea

The Effect of Pregabalin on Shoulder Pain of Patients With Myofascial Pain Syndrome and Central Sensitization Who Undergo 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Pregabalin group
Drug: Pregabalin
Pregabalin oral intake from the day before surgery to six weeks postoperatively
Other Names:
  • Lyrica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Collaborators

Viatris Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC24MISV0017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuropathic Pain

Clinical Trials on Pregabalin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe