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Die klinische Studie NCT06916650 für Schultersteife 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
Comparing HILT, Steroid Injection, and Manual Therapy for Frozen Shoulder 180 Bewegung
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Die klinische Studie NCT06916650 ist eine interventionsstudie zur Untersuchung von Schultersteife und hat den Status offene rekrutierung. Die Studie startete am 25. April 2025 und soll 180 Teilnehmer aufnehmen. Durchgeführt von Al Hayah University In Cairo ist der Abschluss für 1. August 2027 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 8. April 2025 aktualisiert.
Kurzbeschreibung
This study compares three common treatments for frozen shoulder when added to a standard exercise program: High-Intensity Laser Therapy (HILT), a corticosteroid (steroid) injection into the shoulder joint, and hands-on manual therapy by a physical therapist. A fourth group will receive only the standard exercise program. The goal is to see which combination works best to reduce shoulder pain and improve shoulder func...Mehr anzeigen
Offizieller Titel
Comparative Effectiveness of High-Intensity Laser Therapy Versus Corticosteroid Injection Versus Manual Therapy, Each Combined With Standard Exercise, for Frozen Shoulder (Adhesive Capsulitis): A Randomized Controlled Trial
Erkrankungen
SchultersteifeWeitere Studien-IDs
- COMPARE-FS
NCT-Nummer
Studienbeginn (tatsächlich)
2025-04-25
Zuletzt aktualisiert
2025-04-08
Studienende (vorauss.)
2027-08-01
Geplante Rekrutierung
180
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellHILT + Standard Exercise Participants receive High-Intensity Laser Therapy (HILT) 2 times/week for 6 weeks, plus the Standard Exercise Program. | High-Intensity Laser Therapy (HILT) Nd:YAG laser (1064 nm) applied to anterior, lateral, posterior glenohumeral joint aspects. Three-phase protocol per session: (1) 10 J/cm² @ 10 Hz; (2) 12 J/cm² @ 2000 Hz; (3) 10 J/cm² @ 15 Hz. Total energy \~1200 J/session. Frequency: 2 sessions/week for 6 weeks (12 sessions total). Delivered by trained PTs. Standard Exercise Program Standardized program including pendulum exercises, active-assisted range of motion exercises (e.g., wand, wall climbs), stretching (e.g., cross-body, sleeper stretch), and progressive resistive exercises using resistance bands. Includes supervised instruction/progression and a daily home exercise program component. Supervised instruction frequency: 2 sessions/week for first 6 weeks, then 1 session/week for next 6 wee...Mehr anzeigen |
Aktives VergleichspräparatCorticosteroid Injection + Standard Exercise Participants receive a single ultrasound-guided intra-articular corticosteroid injection at baseline, plus the Standard Exercise Program. | Ultrasound-Guided Intra-articular Corticosteroid Injection Single injection into the glenohumeral joint under ultrasound guidance. Consists of 40 mg methylprednisolone acetate combined with 4 ml of 1% lidocaine hydrochloride. Delivered at baseline by an experienced orthopedic physician. Standard Exercise Program Standardized program including pendulum exercises, active-assisted range of motion exercises (e.g., wand, wall climbs), stretching (e.g., cross-body, sleeper stretch), and progressive resistive exercises using resistance bands. Includes supervised instruction/progression and a daily home exercise program component. Supervised instruction frequency: 2 sessions/week for first 6 weeks, then 1 session/week for next 6 wee...Mehr anzeigen |
Aktives VergleichspräparatManual Therapy + Standard Exercise Participants receive manual therapy 2 times/week for 6 weeks, plus the Standard Exercise Program. | Manuelle Therapie Skilled hands-on techniques including glenohumeral joint mobilizations (Maitland grades III-IV), posterior capsule stretching, scapular mobilization, and soft tissue techniques targeting restricted tissues. Session duration: \~30 minutes. Frequency: 2 sessions/week for 6 weeks (12 sessions total). Delivered by PTs specialized in manual therapy. Standard Exercise Program Standardized program including pendulum exercises, active-assisted range of motion exercises (e.g., wand, wall climbs), stretching (e.g., cross-body, sleeper stretch), and progressive resistive exercises using resistance bands. Includes supervised instruction/progression and a daily home exercise program component. Supervised instruction frequency: 2 sessions/week for first 6 weeks, then 1 session/week for next 6 wee...Mehr anzeigen |
Aktives VergleichspräparatStandard Exercise Alone Participants receive the Standard Exercise Program only. | Standard Exercise Program Standardized program including pendulum exercises, active-assisted range of motion exercises (e.g., wand, wall climbs), stretching (e.g., cross-body, sleeper stretch), and progressive resistive exercises using resistance bands. Includes supervised instruction/progression and a daily home exercise program component. Supervised instruction frequency: 2 sessions/week for first 6 weeks, then 1 session/week for next 6 wee...Mehr anzeigen |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Change in Shoulder Pain Intensity | Visual Analogue Scale (VAS) for Pain. Change from baseline in average shoulder pain over the past week, measured on a 10 cm horizontal VAS, where 0 cm = no pain and 10 cm = worst imaginable pain. Lower scores indicate less pain. MCID estimated at 1.4 cm. | Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3) |
Change in Shoulder Pain and Disability | Shoulder Pain and Disability Index (SPADI). Change from baseline in the total SPADI score. SPADI consists of 13 items assessing pain (5 items) and disability (8 items). Total score ranges from 0-100, with lower scores indicating less pain and disability. | Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3) |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Change in Passive Shoulder Range of Motion (ROM) | Change from baseline in passive shoulder ROM measured in degrees for: External Rotation (at side), Abduction (in scapular plane), Flexion, and Internal Rotation (vertebral level reached). Measured using a standard goniometer. | Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3) |
Patient Global Rating of Change | Global Rating of Change (GRC) Scale. Patient's self-rated overall change in their shoulder condition since starting the study, measured on a Likert scale (e.g., 7-point scale from "very much worse" to "very much improved"). Assessed relative to baseline. | 6 weeks (T1), 12 weeks (T2), 6 months (T3) |
Incidence of Adverse Events | Number, type, and severity of any adverse events (AEs) reported by participants or observed by study staff throughout the study duration, categorized by potential relationship to the assigned intervention (e.g., post-injection flare, skin reaction to HILT, increased pain after manual therapy/exercise). | Throughout study participation (up to 6 months) |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
40 Years
Zugelassene Geschlechter
Alle
Age between 40 and 70 years, inclusive. Clinical diagnosis of primary (idiopathic) frozen shoulder, defined by shoulder pain and ≥50% restriction in passive external rotation compared to the contralateral (unaffected) shoulder.
Symptom duration between 3 and 9 months. Average shoulder pain intensity ≥ 4 on a 10-cm Visual Analogue Scale (VAS) over the past week.
Normal or age-appropriate radiographic findings of the glenohumeral joint (ruling out significant arthritis, fractures, calcific tendinitis).
Willingness and ability to attend scheduled treatment/assessment sessions. Ability to understand study procedures and provide written informed consent.
Secondary frozen shoulder (e.g., post-traumatic, post-surgical, related to systemic disease like diabetes - clarify if diabetes is excluded or just secondary FS from diabetes).
Clinical or imaging evidence of significant rotator cuff tear requiring specific management.
Radiographic evidence of moderate to severe glenohumeral osteoarthritis (e.g., Kellgren-Lawrence grade ≥ 3).
Previous surgery on the index shoulder. Significant neurological disorders affecting shoulder or upper extremity function (e.g., cervical radiculopathy, stroke).
Received a corticosteroid injection in the index shoulder within the past 3 months.
Known contraindications to corticosteroid injections (e.g., uncontrolled diabetes, allergy, local infection).
Known contraindications to High-Intensity Laser Therapy (e.g., active malignancy in the treatment area, photosensitivity, pacemaker over treatment area).
Current participation in another interventional clinical trial for shoulder pain.
Al Hayah University In CairoZentrale Studienkontakte
Kontakt: Ibrahim Zoheiry, Ph.D, 01277774949, [email protected]
Kontakt: Mohamed ElMeligie, Ph.D, [email protected]
1 Studienstandorte in 1 Ländern
Faculty of Physical Therapy, Al Hayah University, Cairo, 12311, Egypt
Mohamed ElMeligie, Ph.D, Kontakt, 01159880001, [email protected]
Offene Rekrutierung