NCT07493226 Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis

Eligibility & Interventions

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This trial targets 120 participants in total. It began in 2026-04-01 with a primary completion date of 2027-02-28.

Brief Summary

Patients aged 18-75 years who present to a tertiary rehabilitation hospital with shoulder pain and restricted range of motion, and who consent to participate, will be included in the study. Eligibility will be determined based on predefined inclusion and exclusion criteria. Eligible patients will be randomly assigned to receive one of several nonsteroidal anti-inflammatory drugs (NSAIDs) with differing chemical properties (e.g., diclofenac, meloxicam, or indomethacin), in combination with a home-based exercise program for shoulder adhesive capsulitis. Patients' sociodemographic data, as well as detailed clinical and examination findings and baseline outcomes, will be recorded. Patients will be informed about their condition, and modifications to activities of daily living will be recommended.Patients' pain phenotypes (nociceptive, neuropathic, nociplastic) will be categorized based on clinical history and questionnaires, and it will be determined which pain types derive greater benefit from NSAIDs. Follow-up assessments will be conducted at the end of the first and second weeks. At the first-week follow-up, pain intensity will be evaluated using the Visual Analog Scale (VAS). If the treatment is deemed effective (defined as a ≥3-point reduction or ≥50% decrease in VAS), the same NSAID will be continued for an additional week; otherwise, it will be switched to an alternative NSAID with a different biochemical profile (group). The outcomes assessments will be performed by a blinded evaluator to minimize bias.

Eligibility Criteria

Inclusion Criteria: 1. Being between 18-75 years of age 2. Having shoulder pain that has lasted for at least one month and being diagnosed with primary frozen shoulder 3. Having a VAS pain level ≥ 4/10 4. Having ≥30 degrees of range of motion restriction in at least two planes (flexion, abduction, or external rotation) 5. Not having any exclusion criteria and agreeing to participate in the study voluntarily Exclusion Criteria: 1. Patients with a history of shoulder trauma, those with musculoskeletal disorders characterized by pain and loss of function in the affected extremity (such as lateral epicondylitis, flexor tendon injury, de Quervein's tenosynovitis) 2. Presence of neurological involvement such as stroke, brachial plexus injury, Parkinson's disease, and cervical spine injury with or without radiculopathy 3. History of shoulder surgery, malignancy or tumor in the shoulder, those who have undergone shoulder manipulation 4. Presence of shoulder arthritis, rotator cuff tear or other shoulder injuries, thoracic outlet syndrome 5. Systemic disease affecting the shoulder region, severe degeneration or trauma (e.g., osteoarthritis, rheumatoid arthritis, history of labrum or articular cartilage injuries), inflammatory rheumatic diseases 6. Those who have received steroid injections into the affected extremity within the last 3 months, those using oral steroids or NSAIDs, those receiving any surgical or interventional treatment, or Planned individuals: 7. Those who are pregnant or lactating 8. Those with uncontrolled diabetes, heart failure, uncontrolled systemic disease (liver disease, chronic kidney failure, significant endocrine disorders, etc.) 9. Those with communication problems, severe psychiatric disorders 10. Those allergic to NSAIDs or with any contraindications 11. Those with bleeding, coagulation disorders, stomach ulcers, or symptomatic gastritis

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