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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Taipei
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Taipei, Taipei, Taïwan, 114
- Tri-Service General Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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Comparateur actif: 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.
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Supervised physical therapy program including joint mobilization, stretching, and strengthening exercises, conducted twice weekly for 6 weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Shoulder Pain and Disability Index (SPADI) Total Score
Délai: Baseline, 4 weeks, 6 weeks, 8 weeks, and 12 weeks
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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.
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Baseline, 4 weeks, 6 weeks, 8 weeks, and 12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
SPADI Item - Wearing a Pullover Shirt
Délai: Baseline, 4, 6, 8, and 12 weeks
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Item-level SPADI score for wearing a pullover shirt (requires combined abduction and external rotation), rated 0-10 (0=no difficulty, 10=worst difficulty).
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Baseline, 4, 6, 8, and 12 weeks
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SPADI Item - Putting on Pants or Shorts
Délai: Time Frame: Baseline, 4, 6, 8, and 12 weeks
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Item-level SPADI score for putting on pants or shorts (requires internal rotation and extension), rated 0-10.
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Time Frame: Baseline, 4, 6, 8, and 12 weeks
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SPADI Item - Pain on Arm Traction
Délai: Time Frame: Baseline, 4, 6, 8, and 12 weeks
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Item-level SPADI pain score during arm traction of the affected side (reflects capsular tension), rated 0-10.
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Time Frame: Baseline, 4, 6, 8, and 12 weeks
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Shoulder Range of Motion
Délai: Baseline, 4, 6, 8, and 12 weeks
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Active and passive range of motion of the shoulder (flexion, abduction, external rotation) measured by gravity goniometer by a blinded assessor.
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Baseline, 4, 6, 8, and 12 weeks
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- C202205160
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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