Ultrasound-guided Anterior Hydrodilatation in Shoulder Adhesive Capsulitis
Primary Purpose
Shoulder Capsulitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound-guided posterior hydrodilatation
corticosteroid, saline, and local anesthetic
guided stretching and strengthening exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Capsulitis
Eligibility Criteria
Inclusion Criteria:
- patients aged 35 to 60 years,
- patients who suffered pain and stiffness in only one shoulder, for 1 to 6 months
- patients who had restriction of passive motion.
Exclusion Criteria:
- patients with previous trauma,
- patients with neurological
- patients with endocrinal diseases
- patients with shoulder tumor
- patients with arthritis
- people who had received intra-articular shoulder injection within the last 6 months.
- Patients with tendon tear
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
group 1
group 2
Arm Description
Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach
group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach
Outcomes
Primary Outcome Measures
visual analoge state
minimum value: 0 maximum value: 10 higher scores mean a worse outcome.
shoulder pain and disability index
minimum value: 0 maximum value: 100 higher scores mean a worse outcome.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05194852
Brief Title
Ultrasound-guided Anterior Hydrodilatation in Shoulder Adhesive Capsulitis
Official Title
In Shoulder Adhesive Capsulitis, Ultrasound-guided Anterior Hydrodilatation in Rotator Interval is More Effective Than Posterior Approach: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A prospective randomized controlled study among 60 consecutive adhesive capsulitis to compare between the ultrasound-guided anterior hydrodilatation in rotator interval and the posterior approach.
Detailed Description
patients was randomized into two equal groups. Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach; group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach.
Both groups received guided stretching exercises for 3 months after injection. Baseline and 3 months evaluation of pain by visual analogue scale (VAS), shoulder pain and disability index (SPADI), and range of motion (ROM) had been recorded for all patients.
A statistical power analysis was performed after sample size estimation, based on data from the current study (N = 60), comparing group I to group II.
Qualitative data was expressed as numbers and percentages, and Chi-squared test, Quantitative data were expressed as mean and standard deviation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Capsulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
the participants and outcome assessor didn't know the group classification
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Active Comparator
Arm Description
Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach
Arm Title
group 2
Arm Type
Experimental
Arm Description
group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided posterior hydrodilatation
Intervention Description
Group I was treated through posterior approach; The injection needle is introduced at the skin surface just lateral to the transducer and in an oblique lateral to medial direction. Group II was treated through anterior rotator interval approach. A 21-gauge needle is introduced into the rotator interval using an oblique path within the imaging plane of the transducer; from lateral to medial, the needle tip is imaged in real time throughout its passage from superficial to deep and is positioned in the biceps tendon sheath between the coracohumeral ligament above and biceps tendon below. Both groups were given the same guided stretching and strengthening exercise program
Intervention Type
Drug
Intervention Name(s)
corticosteroid, saline, and local anesthetic
Intervention Description
corticosteroid, saline, and local anesthetic
Intervention Type
Other
Intervention Name(s)
guided stretching and strengthening exercise program
Intervention Description
guided stretching and strengthening exercise program
Primary Outcome Measure Information:
Title
visual analoge state
Description
minimum value: 0 maximum value: 10 higher scores mean a worse outcome.
Time Frame
3 months
Title
shoulder pain and disability index
Description
minimum value: 0 maximum value: 100 higher scores mean a worse outcome.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients aged 35 to 60 years,
patients who suffered pain and stiffness in only one shoulder, for 1 to 6 months
patients who had restriction of passive motion.
Exclusion Criteria:
patients with previous trauma,
patients with neurological
patients with endocrinal diseases
patients with shoulder tumor
patients with arthritis
people who had received intra-articular shoulder injection within the last 6 months.
Patients with tendon tear
Facility Information:
Facility Name
Faculty of Medicine
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
31527
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Ultrasound-guided Anterior Hydrodilatation in Shoulder Adhesive Capsulitis
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