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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Being between 18-75 years of age
. Having shoulder pain that has lasted for at least one month and being diagnosed with primary frozen shoulder
. Having a VAS pain level ≥ 4/10
. Having ≥30 degrees of range of motion restriction in at least two planes (flexion, abduction, or external rotation)
Exclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
VAS pain (0-10) (night and movement)
Timeframe: Baseline, Week 1, and Week 2
2
Range of motion (ROM)
Timeframe: Baseline, and Week 2
3
SPADI :Shoulder Pain and Disability Index
Timeframe: Baseline, and Week 2
Trial details
NCT IDNCT07493226
SponsorKonya Beyhekim Training and Research Hospital
. Presence of neurological involvement such as stroke, brachial plexus injury, Parkinson's disease, and cervical spine injury with or without radiculopathy
. History of shoulder surgery, malignancy or tumor in the shoulder, those who have undergone shoulder manipulation
. Presence of shoulder arthritis, rotator cuff tear or other shoulder injuries, thoracic outlet syndrome
. 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
. 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:
. Those who are pregnant or lactating
. Those with uncontrolled diabetes, heart failure, uncontrolled systemic disease (liver disease, chronic kidney failure, significant endocrine disorders, etc.)