Is Combined Steroid and Sodium Hyaluronate Hydrodilatation More Effective Than Isolated Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

Taipei Veterans General Hospital

Status: Enrolling

Conditions: Adhesive Capsulitis

Treatments: Drug: (Sodium Hyaluronate (Hyruan One , LG); Drug: Triamcinolone Acetonide; Drug: normal saline; Drug: lidocaine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05861570

2022-01-001B

Details and patient eligibility

About

This study was conducted to compare the efficacy of hydrodilatation with steroid with hyaluronic acid and steroid for treating adhesive capsulitis.

Full description

Design: a prospective, double-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with steroid ) and group 2 (hydrodilatation with hyaluronic acid and steroid). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Shoulder Pain And Disability Index

Enrollment: 84 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age 35-65 years
2. onset of shoulder stiffness since over a month
3. limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation.

Exclusion criteria

1. ultrasound findings of rotator cuff tears,
2. plain radiography findings of significant glenohumeral joint arthritis,
3. accompanying cervical radiculopathy,
4. systemic inflammatory joint disease,
5. intraarticular injection into the glenohumeral joint within the past 3 months
6. history of surgery on the affected shoulders,
7. regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids,
8. allergy to corticosteroid or lidocaine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

hydrodilatation with steroid

Experimental group

Description:

patient received ultrasound-guided 3cc NS + 40mg triamcinolone + 4cc xylocaine

Treatment:

Drug: lidocaine hydrochloride

Drug: Triamcinolone Acetonide

Drug: normal saline

hydrodilatation with hyaluronic acid and steroid

Active Comparator group

Description:

patient received ultrasound-guided 3cc hyaluronic acid + 40mg triamcinolone + 4cc xylocaine

Treatment:

Drug: (Sodium Hyaluronate (Hyruan One , LG)

Drug: lidocaine hydrochloride

Drug: Triamcinolone Acetonide