Ultrasound-guided Anterior Hydrodilatation in Shoulder Adhesive Capsulitis

Shoulder Capsulitis Clinical Trial

Official title:

In Shoulder Adhesive Capsulitis, Ultrasound-guided Anterior Hydrodilatation in Rotator Interval is More Effective Than Posterior Approach: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05194852
• Other study ID #: hydro1
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: September 28, 2018

Study information

• Verified date: January 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 28, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Shoulder Capsulitis

Intervention

Procedure:
• ultrasound-guided posterior hydrodilatation
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

Drug:
• corticosteroid, saline, and local anesthetic
corticosteroid, saline, and local anesthetic

Other:
• guided stretching and strengthening exercise program
guided stretching and strengthening exercise program

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analoge state	minimum value: 0 maximum value: 10 higher scores mean a worse outcome.	3 months
Primary	shoulder pain and disability index	minimum value: 0 maximum value: 100 higher scores mean a worse outcome.	3 months