Skip to content

Does Axillary Nerve and Inferior Capsule Release Add Extra Benefit in Treating Patients With Adhesive Capsulitis

Does Axillary Nerve and Inferior Capsule Release Add Extra Benefit to Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05921539
Enrollment
72
Registered
2023-06-27
Start date
2021-12-01
Completion date
2025-03-01
Last updated
2023-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis of Shoulder

Brief summary

This study was conducted to compare the efficacy of hydrodilatation with steroid via posterior approach versus hydrodilatation with steroid with axillary nerve injection for treating patients with adhesive capsulitis.

Detailed description

Adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of rotator interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive capsulitis. Design: a prospective, single-blinded, randomized, clinical trial Patient and methods: Patients with adhesive capsulitis were enrolled and randomly allocated into group 1 ( ultrasound guided hydrodilatation with steroid via posterior approach) and group 2 (ultrasound guided hydrodilatation with steroid via posterior approach as well as axillary nerve injection). 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, and Shoulder Pain And Disability Index.

Interventions

DRUGsteroid hydrodilatation

ultrasound-guided steroid hydrodilatation

DRUGaxillary nerve injection

ultrasound-guided axillary nerve injection

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. age 35-65 years (to prevent the inclusion of patients with secondary AC), 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. intra-articular 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. -

Design outcomes

Primary

MeasureTime frameDescription
Shoulder Pain And disability indexChange of the score between 6 weeks and baseline, and change of the score between 12 weeks and baselineThe Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.function. The score is divided into four sections: pain, activity of daily living, ROM and strength

Secondary

MeasureTime frameDescription
pain intensityChange of the score between 6 weeks and baseline, and change of the score between 12 weeks and baselinepain intensity was measured by visual analog scale. Each patient was asked to indicate his/her current level of pain by marking a point on a 100-mm VAS, for which 0 represented no pain and 100 represented unbearable pain.
glenohumeral joint range of motionChange at baseline, 6 weeks, 12 weekschange in degrees of shoulder motion

Countries

Taiwan

Contacts

Primary ContactJia chi C Wang
jcwang0726@gmail.com0919527693

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026