Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07493226 for Frozen Shoulder, Adhesive Capsulitis, Shoulder Pain, NSAID (Non-Steroidal Anti-Inflammatory Drug), Nociplastic Pain, Neuropathic Pain is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis 120 Home-Based Exercise-Based
Clinical Trial NCT07493226 is an interventional study for Frozen Shoulder, Adhesive Capsulitis, Shoulder Pain, NSAID (Non-Steroidal Anti-Inflammatory Drug), Nociplastic Pain, Neuropathic Pain that is recruiting. It started on 1 April 2026 with plans to enroll 120 participants. Led by Konya Beyhekim Training and Research Hospital, it is expected to complete by 30 March 2027. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
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 prop...
Show MoreDetailed Description
This study will include patients presenting to the Physical Medicine and Rehabilitation outpatient clinics of Konya Beyhekim Training and Research Hospital with shoulder pain and restricted range of motion, who are clinically diagnosed with frozen shoulder following a comprehensive evaluation. All patients will be prescribed non-steroidal anti-inflammatory drugs (NSAIDs) as part of analgesic treatment.
A total of 12...
Show MoreOfficial Title
Comparative Efficacy of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) With Distinct Chemical Structures in Shoulder Adhesive Capsulitis and the Role of Pain Phenotypes
Conditions
Frozen ShoulderAdhesive CapsulitisShoulder PainNSAID (Non-Steroidal Anti-Inflammatory Drug)Nociplastic PainNeuropathic PainOther Study IDs
- BeyhekimTRH-RHT2026/5477
NCT ID Number
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2027-03-30
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
frozen shoulder
adhesive capsulitis
shoulder pain
pain phenotypes
exercises
Nonsteroidal Anti-Inflammatory Drugs
adhesive capsulitis
shoulder pain
pain phenotypes
exercises
Nonsteroidal Anti-Inflammatory Drugs
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active Comparatorpropionic acid derivatives Patients will be given oral tablets of ibuprofen or naproxen in this group. | Propionic acid deriaves Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of ibuprofen or naproxen |
Active Comparatoracetic acid derivatives Patients will be given oral tablets of etodolac or diclofenac in this group. | acetic acid derivatives Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of etodolac or diclofenac. |
Active Comparatoroxicam derivatives Patients will be given oral tablets of meloxicam or lornoxicam in this group. | oxicam derivatives Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of meloxicam or lornoxicam. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
VAS pain (0-10) (night and movement) | Visual Analog Scale (VAS) for pain: 0 = no pain, 10 = worst imaginable/unbearable pain. | Baseline, Week 1, and Week 2 |
Range of motion (ROM) | 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. | Baseline, and Week 2 |
SPADI :Shoulder Pain and Disability Index | 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. | Baseline, and Week 2 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
DN4 Neuropathic Pain Questionnaire | This is a questionnaire that compiles symptoms and findings associated with neuropathic pain. It is scored on a scale of 0-10. A score above 4 is considered indicative of neuropathic pain. | Baseline |
Central Sensitization Inventory | This is a 25-item self-report scale that measures central nervous system hypersensitivity to normal stimuli (central sensitization), a condition that plays a role in the pathophysiology of chronic pain. It aids in diagnosis of chronic pain syndromes such as fibromyalgia by scoring common somatic and emotional symptoms on a scale of 0-100. | Baseline |
Sleep Quality Scale | Sleep quality during the preceding week was evaluated using the Single-Item Sleep Quality Scale (SQS), a brief and practical instrument derived from item 6 of the Pittsburgh Sleep Quality Index. The scale evaluates sleep quality using a VAS ranging from 0 to 10, which is then categorized on a 0-4 scale, ranging from 0 (terrible) to 4 (excellent)." | Baseline, and Week 2 |
Pain Catastrophizing Scale | This is a 13-item self-report questionnaire, scored from 0 to 52, that measures negative cognitive and emotional responses to pain experiences, such as helplessness, exaggeration (magnification), and rumination. It is widely used in chronic pain management and in determining a patient's sensitivity to pain. | Baseline, and Week 2 |
Patient satisfaction (subjective impression of improvement) | Patient satisfaction subjective evaluation is the measurement of a patient's personal perceptions, feelings, and expectations regarding the healthcare service received, physician communication, hospital environment, and treatment outcomes, through surveys or interviews.
Patient satisfaction (subjective impression of improvement) was assessed using a five-point Likert-type scale. Response options were defined as follows: 1, "no satisfaction at all"; 2, "not satisfied"; 3, neutral (no positive or negative effect); 4, "satisfied"; and 5, "very satisfied." | 2nd week |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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)
- 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.)
- Those with communication problems, severe psychiatric disorders
- Those allergic to NSAIDs or with any contraindications
- Those with bleeding, coagulation disorders, stomach ulcers, or symptomatic gastritis
Konya Beyhekim Training and Research HospitalStudy Responsible Party
Rukiye Hilal Taygurt, Principal Investigator, Resident doctor, Konya Beyhekim Training and Research Hospital
Study Central Contact
Contact: Rukiye Hilal Taygurt Md., principal investigator, +905389122141, [email protected]
Contact: furkan taygurt Md., relative, +905512203334, [email protected]
1 Study Locations in 1 Countries
Selçuklu
Konya Beyhekim Training and Research Hospital, Konya, Selçuklu, 42000, Turkey (Türkiye)
Konya Beyhekim Training and Research Hospital Physical Therapy and Rehabilitation Center, Contact, 0332 224 30 00, [email protected]
Rukiye Hilal taygurt Md., principal investigator, Contact, 05389122141, [email protected]
Rukiye Hilal Taygurt Md., principal investigator, Principal Investigator
Recruiting