Effect of Pregabalin on Shoulder Pain in Patients With Central Sensitization After Arthroscopic Rotator Cuff Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pregabalin.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tears, Central Sensitisation, Neuropathic Pain. Basic parameters: 20 years — 69 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Pregabalin on Shoulder Pain of Patients With Myofascial Pain Syndrome and Central Sensitization Who Undergo Arthroscopic Rotator Cuff Repair
Overview
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
- Drug Pregabalin
Pregabalin oral intake from the day before surgery to six weeks postoperatively
Primary outcome measures
- The Visual Analogue Scale (VAS) pain score [Time frame: Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months]
Secondary outcome measures (2)
- Constant shoulder score [Time frame: Preoperative, postoperative 6 months and 12 months]
- American shouler and elbow surgeons (ASES) score [Time frame: Preoperative, postoperative 6 months and 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06367998 · PC24MISV0017