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Die klinische Studie NCT07493226 für Schultersteife, Adhäsive Kapsulitis, Schulterschmerzen, NSAID (Non-Steroidal Anti-Inflammatory Drug), Nociplastischer Schmerz, Neuropathischer Schmerz ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis 120 Häuslich Bewegung
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Die klinische Studie NCT07493226 ist eine interventionsstudie zur Untersuchung von Schultersteife, Adhäsive Kapsulitis, Schulterschmerzen, NSAID (Non-Steroidal Anti-Inflammatory Drug), Nociplastischer Schmerz, Neuropathischer Schmerz und hat den Status offene rekrutierung. Die Studie startete am 1. April 2026 und soll 120 Teilnehmer aufnehmen. Durchgeführt von Konya Beyhekim Training and Research Hospital ist der Abschluss für 30. März 2027 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 25. März 2026 aktualisiert.
Kurzbeschreibung
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...
Mehr anzeigenAusführliche Beschreibung
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...
Mehr anzeigenOffizieller Titel
Comparative Efficacy of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) With Distinct Chemical Structures in Shoulder Adhesive Capsulitis and the Role of Pain Phenotypes
Erkrankungen
SchultersteifeAdhäsive KapsulitisSchulterschmerzenNSAID (Non-Steroidal Anti-Inflammatory Drug)Nociplastischer SchmerzNeuropathischer SchmerzWeitere Studien-IDs
- BeyhekimTRH-RHT2026/5477
NCT-Nummer
Studienbeginn (tatsächlich)
2026-04-01
Zuletzt aktualisiert
2026-03-25
Studienende (vorauss.)
2027-03-30
Geplante Rekrutierung
120
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
frozen shoulder
adhesive capsulitis
shoulder pain
pain phenotypes
exercises
Nonsteroidal Anti-Inflammatory Drugs
adhesive capsulitis
shoulder pain
pain phenotypes
exercises
Nonsteroidal Anti-Inflammatory Drugs
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Aktives Vergleichspräparatpropionic 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 |
Aktives Vergleichspräparatacetic 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. |
Aktives Vergleichspräparatoxicam 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. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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 HospitalVerantwortliche Partei
Rukiye Hilal Taygurt, Hauptprüfer, Resident doctor, Konya Beyhekim Training and Research Hospital
Zentrale Studienkontakte
Kontakt: Rukiye Hilal Taygurt Md., principal investigator, +905389122141, [email protected]
Kontakt: furkan taygurt Md., relative, +905512203334, [email protected]
1 Studienstandorte in 1 Ländern
Selçuklu
Konya Beyhekim Training and Research Hospital, Konya, Selçuklu, 42000, Turkey (Türkiye)
Konya Beyhekim Training and Research Hospital Physical Therapy and Rehabilitation Center, Kontakt, 0332 224 30 00, [email protected]
Rukiye Hilal taygurt Md., principal investigator, Kontakt, 05389122141, [email protected]
Rukiye Hilal Taygurt Md., principal investigator, Hauptprüfer
Offene Rekrutierung