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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-69
SponsorThe Catholic University of Korea

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pregabalin

    Drug

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

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Pregabalin groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The Visual Analogue Scale (VAS) pain score

Pain score evaluation from 0 to 10, 10 meaning the maximum pain

Time frame
Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months

Secondary outcomes

1

Constant shoulder score

Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function

Time frame
Preoperative, postoperative 6 months and 12 months
2

American shouler and elbow surgeons (ASES) score

Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function

Time frame
Preoperative, postoperative 6 months and 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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