Propionic acid deriaves: Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of ibuprofen or naproxen
acetic acid derivatives: Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of etodolac or diclofenac.
oxicam derivatives: Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of meloxicam or lornoxicam.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
VAS pain (0-10) (night and movement) — Baseline, Week 1, and Week 2 Visual Analog Scale (VAS) for pain: 0 = no pain, 10 = worst imaginable/unbearable pain.
Range of motion (ROM) — Baseline, and Week 2 Movements of the affected shoulder (flexion, abduction, internal and external rotation) will be measured and recorded using a goniometer. The presence of limitation will be assessed by comparing it to the unaffected side.
SPADI :Shoulder Pain and Disability Index — Baseline, and Week 2 The Shoulder Pain and Functionality Index (SPADI) is a self-report scale developed to assess the severity of shoulder pain and its impact on functionality. The scale consists of two sub-sections: pain (5 items) and functionality (8 items). Each item is scored from 0 (no pain or difficulty) to 10 (unbearable pain or extreme difficulty). The total score ranges from 0 to 100; higher scores indicate more severe pain and loss of function.
Trial sites (1)
Facility
City
Region
Status
Konya Beyhekim Training and Research Hospital
Konya
Selçuklu
Recruiting
More Konya Beyhekim Training and Research Hospital trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.