Comparing different NSAIDs plus home exercises for frozen shoulder

Comparative Efficacy of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) With Distinct Chemical Structures in Shoulder Adhesive Capsulitis and the Role of Pain Phenotypes

This will test whether taking one of several NSAIDs (diclofenac, meloxicam, or indomethacin) together with home shoulder exercises helps adults aged 18–75 with frozen shoulder and whether pain type changes the benefit.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Konya Beyhekim Training and Research Hospital (other gov)
• Locations: 1 site (Konya, Selçuklu)
• Trial ID: NCT07493226 on ClinicalTrials.gov

What this trial studies

Adults aged 18–75 with primary frozen shoulder and at least one month of shoulder pain will be enrolled at Konya Beyhekim Training and Research Hospital and randomized to receive one of several NSAIDs (diclofenac, meloxicam, or indomethacin) alongside a home-based shoulder exercise program. Investigators will record sociodemographic data, detailed clinical and examination findings, imaging where relevant, and baseline outcome measures before treatment. Patients' pain phenotypes will be classified as nociceptive, neuropathic, or nociplastic using clinical history and questionnaires, and block randomization will assign about 120 participants to chemically distinct NSAID groups. Outcomes will compare pain, range of motion, and function across drug groups and pain phenotypes to identify which combinations produce greater symptom improvement.

Who should consider this trial

Good fit: Adults 18–75 with primary frozen shoulder, at least one month of shoulder pain, VAS ≥4/10, and ≥30° restriction in two or more planes who can attend clinic visits and provide informed consent are ideal candidates.

Not a fit: Patients with secondary shoulder problems such as rotator cuff tear, shoulder arthritis, prior shoulder surgery or manipulation, recent trauma, neurologic disorders, malignancy, or other listed exclusion criteria are unlikely to be eligible or to benefit from this specific protocol.

Why it matters

Potential benefit: If successful, the results could help clinicians choose the best NSAID and exercise plan for people with frozen shoulder based on their pain type, improving pain relief and shoulder movement.

How similar studies have performed: NSAIDs plus exercise are commonly used and have shown symptom benefit in frozen shoulder, but directly comparing chemically distinct NSAIDs and linking response to nociceptive/neuropathic/nociplastic phenotypes is relatively novel.

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

Where this trial is running

Konya, Selçuklu

• Konya Beyhekim Training and Research Hospital — Konya, Selçuklu, Turkey (Türkiye) (RECRUITING)

Study contacts

• Study coordinator: Rukiye Hilal Taygurt Md., principal investigator

Conditions: Frozen Shoulder, Adhesive Capsulitis, Shoulder Pain, NSAID, Nociplastic Pain, Neuropathic Pain, frozen shoulder, adhesive capsulitis