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Hyaluronic Acid Injection Combined With Rehabilitation for Frozen Shoulder (HA - AC)

12 maggio 2026 aggiornato da: Chih-Ya Chang, Tri-Service General Hospital

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Taiwan
    • Taipei
      • Taipei, Taipei, Taiwan, 114
        • Tri-Service General Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Hyaluronic Acid (HA)
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.
Altro: Rehabilitation
Supervised physical therapy program including joint mobilization, stretching, and strengthening exercises, conducted twice weekly for 6 weeks.
Comparatore attivo: 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.
Altro: Rehabilitation
Supervised physical therapy program including joint mobilization, stretching, and strengthening exercises, conducted twice weekly for 6 weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Shoulder Pain and Disability Index (SPADI) Total Score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
SPADI Item - Wearing a Pullover Shirt
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Tri-Service General Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 febbraio 2025

Completamento primario (Effettivo)

5 marzo 2025

Completamento dello studio (Effettivo)

28 aprile 2026

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • C202205160

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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