Clinical trial NCT05921539: Does Axillary Nerve and Inferior Capsule Release Add Extra Benefit in Treating Patients With Adhesive Capsulitis
Official title: Does Axillary Nerve and Inferior Capsule Release Add Extra Benefit to Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesive Capsulitis of Shoulder
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2023-06-27
Enrollment: 72
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: Shoulder Pain And disability index
timeFrame: Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
Secondary outcomes:
measure: pain intensity
timeFrame: Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
measure: glenohumeral joint range of motion
timeFrame: Change at baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: