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Die klinische Studie NCT06491745 für Schultersteife, Corticosteroid Injection, Physiotherapie, Extrakorporale Stoßwellentherapie, Rehabilitation 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
Is Adding Extracorporeal Shock Wave Therapy to Physiotherapy and Corticosteroid Injection Beneficial for Frozen Shoulder 94 Randomisiert
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Die klinische Studie NCT06491745 ist eine interventionsstudie zur Untersuchung von Schultersteife, Corticosteroid Injection, Physiotherapie, Extrakorporale Stoßwellentherapie, Rehabilitation und hat den Status offene rekrutierung. Die Studie startete am 1. August 2024 und soll 94 Teilnehmer aufnehmen. Durchgeführt von Shin Kong Wu Ho-Su Memorial Hospital ist der Abschluss für 31. Dezember 2028 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 30. Dezember 2025 aktualisiert.
Kurzbeschreibung
Frozen shoulder, or adhesive capsulitis of the shoulder, is a common clinical problem characterized by pain, loss of both passive and active range of motion (ROM) of glenohumeral joint (GHJ), leads to functional limitation, and reduces quality of life. Primary frozen shoulder occurs without any obvious connection to any other condition, and secondary frozen shoulder is related to some medical problems, such as an inj...Mehr anzeigen
Ausführliche Beschreibung
Intra-articular and subdeltoid bursal corticosteroid injection and physical therapy (PT) are commonly used nonsurgical treatments for frozen shoulder and have shown good benefits. However, because of complex clinical pictures and overlapping stages, even after the above treatments, pain and contracture of affected shoulder may still exist, and adjuvant therapy is often needed throughout the course of treatment. Over ...Mehr anzeigen
Offizieller Titel
Is Adding Extracorporeal Shock Wave Therapy to Physiotherapy and Corticosteroid Injection Beneficial for Frozen Shoulder?
Erkrankungen
SchultersteifeCorticosteroid InjectionPhysiotherapieExtrakorporale StoßwellentherapieRehabilitationWeitere Studien-IDs
- 20231204R
- NSTC 113-2314-B-341-003 - (Andere Zuwendungs-/Finanzierungsnummer) (National Science and Technology Council)
- NSTC 114-2314-B-341-001 - (Andere Zuwendungs-/Finanzierungsnummer) (National Science and Technology Council)
NCT-Nummer
Studienbeginn (tatsächlich)
2024-08-01
Zuletzt aktualisiert
2025-12-30
Studienende (vorauss.)
2028-12-31
Geplante Rekrutierung
94
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
Frozen shoulder
corticosteroid injection
physical therapy
extracorporeal shock wave therapy
rehabilitation
corticosteroid injection
physical therapy
extracorporeal shock wave therapy
rehabilitation
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Aktives VergleichspräparatESWT+PT+corticosteroid injection, ESWT group ESWT group. Patients in the ESWT group will receive ESWT, physical therapy, and both shoulder joint (glenohumeral joint, GHJ) and SASD bursa injection for 2 times in a 2-week interval. 3ml triamcinolone (1ml triamcinolone= 10mg) will be added to 3ml 1% xylocaine to make 6ml injectate. Among them, 4ml injectate will be injected into the posterior GHJ with a 7 cm 23-gauge needle under ultrasound (US) guidance. After wi...Mehr anzeigen | Sham ESWT+PT+corticosteroid injection, SHAM group. SHAM group. The participants will receive the same dosage and technique of corticosteroid posterior GHJ and SASD bursa injection for 2 times at 2 weekly interval as participants do in the ESWT group. For creating a single-blinded condition, they will also receive 4 ESWT treatments at weekly interval except that the energy flux density is set at 0.04 mJ/mm2. For sham ESWT, the machine still makes a noise with every sh...Mehr anzeigen |
Aktives VergleichspräparatSham ESWT+PT+corticosteroid injection, SHAM group. SHAM group. The participants will receive the same dosage and technique of corticosteroid posterior GHJ and SASD bursa injection for 2 times at 2 weekly interval as participants do in the ESWT group. For creating a single-blinded condition, they will also receive 4 ESWT treatments at weekly interval except that the energy flux density is set at 0.04 mJ/mm2. For sham ESWT, the machine still makes a noise with every sh...Mehr anzeigen | ESWT+PT+corticosteroid injection, ESWT group ESWT group. Patients in the ESWT group will receive ESWT, physical therapy, and both shoulder joint (glenohumeral joint, GHJ) and SASD bursa injection for 2 times in a 2-week interval. 3ml triamcinolone (1ml triamcinolone= 10mg) will be added to 3ml 1% xylocaine to make 6ml injectate. Among them, 4ml injectate will be injected into the posterior GHJ with a 7 cm 23-gauge needle under ultrasound (US) guidance. After wi...Mehr anzeigen |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
The Shoulder Pain and Disability Index (SPADI) | The SPADI is a self-administered questionnaire that evaluate the pain and disability of shoulder diseases. It has 2 subclasses (pain and disability) that consists of 13 items. The pain domain has 5 items and the disabilities domain has 8 items. The SPADI score, which ranges between 0 (best score) and 100 (worst score), is calculated by averaging the scores from the 2 subclasses. | Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment. |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
The pain visual analog scale (VAS) | The pain VAS is obtained using a 100-mm-long horizontal line, with 0 mm on the left, indicating no pain, and 100 mm on the right, indicating very severe pain.22 The pain at rest is defined as rest pain, and pain on maximal abduction of the affected shoulder is defined as activity pain. The reliability of pain VAS is 0.94, but in the absence of a criterion standard for pain, criterion validity cannot be evaluated. | Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment. |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
20 Years
Zugelassene Geschlechter
Alle
- age between 20 to 80 years old;
- shoulder pain for ≥ 1 month;
- > 30% loss of passive range of motion (ROM) of the affected shoulder in external rotation and/or abduction, comparing with the sound side;
- pain visual analog scale on maximal passive external rotation or abduction > 4;
- showing willing to receive ESWT, shoulder joint injection, and attend regular physical therapy programs for 8 weeks.
- severe systemic disorders including cancer, stroke, or cardiopulmonary diseases;
- uncontrolled DM;
- rotator cuff tear or calcification of the affected shoulder;
- fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders;
- a history of drug allergy to local anesthetics or corticosteroids;
- pregnancy;
- receiving ESWT, corticosteroid joint or bursa injection of the affected shoulder during the preceding three months
Shin Kong Wu Ho-Su Memorial HospitalVerantwortliche Partei
Lin-Fen Hsieh, Hauptprüfer, Study Principal Investigator, Shin Kong Wu Ho-Su Memorial Hospital
Zentrale Studienkontakte
Kontakt: Lin-Fen Hsieh, +886-28332211, [email protected]
1 Studienstandorte in 1 Ländern
Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan
Lin-Fen Hsieh, M.D., Kontakt, +886-28332211, [email protected]
Offene Rekrutierung