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

NCT ID: NCT05861570

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-18

Study Completion Date

2024-04-06

Brief Summary

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

Detailed Description

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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

Conditions

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Adhesive Capsulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double (Participant, Outcomes Assessor)

Study Groups

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hydrodilatation with steroid

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

Group Type EXPERIMENTAL

normal saline

Intervention Type DRUG

Ultrasound guided injection using 3ml normal saline

lidocaine hydrochloride

Intervention Type DRUG

Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)

Triamcinolone Acetonide

Intervention Type DRUG

ultrasound guided steroid injection using 4ml of 40mg triamcinolone acetonide

hydrodilatation with hyaluronic acid and steroid

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

Group Type ACTIVE_COMPARATOR

(Sodium Hyaluronate (Hyruan One , LG)

Intervention Type DRUG

Ultrasound guided injection using 3ml of Sodium Hyaluronate

lidocaine hydrochloride

Intervention Type DRUG

Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)

Triamcinolone Acetonide

Intervention Type DRUG

ultrasound guided steroid injection using 4ml of 40mg triamcinolone acetonide

Interventions

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normal saline

Ultrasound guided injection using 3ml normal saline

Intervention Type DRUG

(Sodium Hyaluronate (Hyruan One , LG)

Ultrasound guided injection using 3ml of Sodium Hyaluronate

Intervention Type DRUG

lidocaine hydrochloride

Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)

Intervention Type DRUG

Triamcinolone Acetonide

ultrasound guided steroid injection using 4ml of 40mg triamcinolone acetonide

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jia chi wang

Role: CONTACT

0919527693

Facility Contacts

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Jia chi Wang

Role: primary

0919527693

Other Identifiers

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2022-01-001B

Identifier Type: -

Identifier Source: org_study_id

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