Hyaluronic Acid Injection Combined With Rehabilitation for Frozen Shoulder (HA - AC)
Clinical Outcomes of Ultrasound-Guided Intra-Articular Hyaluronic Acid Injection Combined With Rehabilitation in Adhesive Capsulitis: A Randomized Controlled Trial
This randomized controlled trial evaluates the clinical efficacy of ultrasound-guided intra-articular hyaluronic acid injection combined with rehabilitation in patients with adhesive capsulitis (frozen shoulder).
Participants were randomly assigned to either an injection plus rehabilitation group or a rehabilitation-only group. The injection group received ultrasound-guided intra-articular hyaluronic acid once weekly for three weeks, along with a standardized rehabilitation program for six weeks. The control group received the same rehabilitation program without injection.
Clinical outcomes were assessed at multiple time points, including baseline, 4, 6, 8, and 12 weeks. The primary outcome was the change in the Shoulder Pain and Disability Index (SPADI) total score. Secondary outcomes included SPADI pain and disability subscales, as well as shoulder range of motion.
The trial was registered retrospectively at ClinicalTrials.gov (NCT07570095) after study completion due to administrative oversight.
The study was conducted in accordance with the protocol approved by the Tri-Service General Hospital Institutional Review Board (approval no. C202205160) prior to enrollment. The IRB-approved protocol specified the eligibility criteria and outcome measures reported in this record; discrepancies in the initial registry entry have been corrected in this amendment.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Adhesive capsulitis is a common musculoskeletal disorder characterized by progressive pain and restricted range of motion of the shoulder joint, leading to significant functional impairment. Although rehabilitation remains the cornerstone of treatment, the additional benefit of intra-articular hyaluronic acid injection remains controversial.
This randomized controlled trial aimed to evaluate the clinical efficacy of ultrasound-guided intra-articular injection of non-cross-linked hyaluronic acid combined with a structured rehabilitation program in patients with adhesive capsulitis.
Participants were randomly assigned to two groups: an injection plus rehabilitation group and a rehabilitation-only group. The injection group received ultrasound-guided intra-articular hyaluronic acid injections once weekly for three consecutive weeks. Both groups underwent a standardized rehabilitation program twice weekly for six weeks, including range of motion exercises, stretching, and strengthening under the supervision of a physical therapist.
Clinical outcomes were assessed at multiple time points, including baseline, 4, 6, 8, and 12 weeks. The primary outcome measure was the change in the Shoulder Pain and Disability Index (SPADI) total score over time. Secondary outcomes included SPADI pain and disability subscales, as well as shoulder external rotation range of motion.
The trial was registered retrospectively at ClinicalTrials.gov (NCT07570095) after study completion due to administrative oversight.
The study was conducted in accordance with the protocol approved by the Tri-Service General Hospital Institutional Review Board (approval no. C202205160) prior to enrollment. The IRB-approved protocol specified the eligibility criteria and outcome measures reported in this record; discrepancies in the initial registry entry have been corrected in this amendment.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Taipei
-
Taipei, Taipei, Tchaj-wan, 114
- Tri-Service General Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Adults aged 40 to 70 years.
- Clinical diagnosis of frozen-phase primary adhesive capsulitis characterized by predominant stiffness as the chief complaint, with symptom duration of at least 3 months, minimal resting pain, and absence of nocturnal pain.
- Limitation of both active and passive shoulder range of motion, particularly in external rotation.
- Ability to understand the study procedures and provide informed consent.
Exclusion Criteria:
- Prior shoulder surgery or fracture on the affected side.
- Rotator cuff tear confirmed by imaging.
- Glenohumeral osteoarthritis or inflammatory joint disease.
- Neurological disorders affecting shoulder function.
- Previous intra-articular injection within the past 3 months.
- Contraindications to hyaluronic acid injection.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Hyaluronic Acid Injection + Rehabilitation
Participants receive ultrasound-guided intra-articular injection of non-cross-linked hyaluronic acid (10 mg/mL, once weekly for 3 consecutive weeks) combined with a standardized rehabilitation program consisting of joint mobilization, stretching, and strengthening exercises, performed twice weekly for 6 weeks.
|
Non-cross-linked hyaluronic acid (10 mg/mL) administered via ultrasound-guided intra-articular injection into the affected shoulder joint once weekly for 3 weeks.
Supervised physical therapy program including joint mobilization, stretching, and strengthening exercises, conducted twice weekly for 6 weeks.
|
|
Aktivní komparátor: Rehabilitation Alone
Participants receive a standardized rehabilitation program including joint mobilization, stretching, and strengthening exercises, performed twice weekly for 6 weeks without hyaluronic acid injection.
|
Supervised physical therapy program including joint mobilization, stretching, and strengthening exercises, conducted twice weekly for 6 weeks.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Shoulder Pain and Disability Index (SPADI) Total Score
Časové okno: Baseline, 4 weeks, 6 weeks, 8 weeks, and 12 weeks
|
The SPADI is a validated questionnaire assessing shoulder pain and functional disability, with total scores ranging from 0 to 100.
Higher scores indicate greater impairment.
|
Baseline, 4 weeks, 6 weeks, 8 weeks, and 12 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
SPADI Item - Wearing a Pullover Shirt
Časové okno: Baseline, 4, 6, 8, and 12 weeks
|
Item-level SPADI score for wearing a pullover shirt (requires combined abduction and external rotation), rated 0-10 (0=no difficulty, 10=worst difficulty).
|
Baseline, 4, 6, 8, and 12 weeks
|
|
SPADI Item - Putting on Pants or Shorts
Časové okno: Time Frame: Baseline, 4, 6, 8, and 12 weeks
|
Item-level SPADI score for putting on pants or shorts (requires internal rotation and extension), rated 0-10.
|
Time Frame: Baseline, 4, 6, 8, and 12 weeks
|
|
SPADI Item - Pain on Arm Traction
Časové okno: Time Frame: Baseline, 4, 6, 8, and 12 weeks
|
Item-level SPADI pain score during arm traction of the affected side (reflects capsular tension), rated 0-10.
|
Time Frame: Baseline, 4, 6, 8, and 12 weeks
|
|
Shoulder Range of Motion
Časové okno: Baseline, 4, 6, 8, and 12 weeks
|
Active and passive range of motion of the shoulder (flexion, abduction, external rotation) measured by gravity goniometer by a blinded assessor.
|
Baseline, 4, 6, 8, and 12 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- C202205160
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Hyaluronic Acid (HA)
-
McMaster UniversityAjinomoto USA, INC.DokončenoPsychologické jevy: Centrální únavaKanada
-
National Cancer Centre, SingaporeSingapore General Hospital; Singhealth Duke-NUS Oncology Academic Clinical...Dokončeno
-
SciVision Biotech Inc.Zatím nenabírámeKorekce nasolabiálních záhybůTchaj-wan
-
Ospedale Policlinico San MartinoUniversita degli Studi di Genova; IRCSS Istituto Dermopatico dell'Immacolata...DokončenoDiabetický vřed na nohou | PRP | Alogenní | Kožní lézeItálie
-
Hadassah Medical OrganizationDokončeno
-
Galderma R&DUkončenoAugmentace obličejové tkáněŠvédsko
-
Lumos DiagnosticsAptatek BiosciencesDokončeno
-
University of Colorado, DenverJiž není k dispozici
-
Universitätsklinikum Hamburg-EppendorfNábor