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

Primary Purpose

Adhesive Capsulitis of Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
steroid hydrodilatation
axillary nerve injection
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis of Shoulder

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age 35-65 years (to prevent the inclusion of patients with secondary AC), onset of shoulder stiffness since over a month 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: ultrasound findings of rotator cuff tears plain radiography findings of significant glenohumeral joint arthritis accompanying cervical radiculopathy systemic inflammatory joint disease intra-articular injection into the glenohumeral joint within the past 3 months history of surgery on the affected shoulders regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids allergy to corticosteroid or lidocaine. -

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hydrodilatation and axillary nerve injection

hydrodilatation only

Arm Description

patient received ultrasound-guided steroid hydrodilatation via posterior recess

patient received ultrasound-guided steroid hydrodilatation only

Outcomes

Primary Outcome Measures

Shoulder Pain And disability index
The 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 Outcome Measures

pain intensity
pain 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 motion
change in degrees of shoulder motion

Full Information

First Posted
November 22, 2021
Last Updated
June 16, 2023
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05921539
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis of Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hydrodilatation and axillary nerve injection
Arm Type
Experimental
Arm Description
patient received ultrasound-guided steroid hydrodilatation via posterior recess
Arm Title
hydrodilatation only
Arm Type
Active Comparator
Arm Description
patient received ultrasound-guided steroid hydrodilatation only
Intervention Type
Drug
Intervention Name(s)
steroid hydrodilatation
Intervention Description
ultrasound-guided steroid hydrodilatation
Intervention Type
Drug
Intervention Name(s)
axillary nerve injection
Intervention Description
ultrasound-guided axillary nerve injection
Primary Outcome Measure Information:
Title
Shoulder Pain And disability index
Description
The 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
Time Frame
Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
Secondary Outcome Measure Information:
Title
pain intensity
Description
pain 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.
Time Frame
Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
Title
glenohumeral joint range of motion
Description
change in degrees of shoulder motion
Time Frame
Change at baseline, 6 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 35-65 years (to prevent the inclusion of patients with secondary AC), onset of shoulder stiffness since over a month 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: ultrasound findings of rotator cuff tears plain radiography findings of significant glenohumeral joint arthritis accompanying cervical radiculopathy systemic inflammatory joint disease intra-articular injection into the glenohumeral joint within the past 3 months history of surgery on the affected shoulders regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids allergy to corticosteroid or lidocaine. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia chi C Wang
Phone
0919527693
Email
jcwang0726@gmail.com
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
241
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia chi C wang
Phone
0919527693
Email
jcwang0726@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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