Ultrasound-guided Anterior Hydrodilatation in Shoulder Adhesive Capsulitis

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT05194852

Collaborator

(none)

Enrollment

Location

Arms

8.8

Actual Duration (Months)

6.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Capsulitis	Procedure: ultrasound-guided posterior hydrodilatation Drug: corticosteroid, saline, and local anesthetic Other: guided stretching and strengthening exercise program	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

the participants and outcome assessor didn't know the group classification

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 2, 2018

Actual Primary Completion Date :

Jun 30, 2018

Actual Study Completion Date :

Sep 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group 1 Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach	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
Experimental: group 2 group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach	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 Other: guided stretching and strengthening exercise program guided stretching and strengthening exercise program

Arm

Intervention/Treatment

Active Comparator: group 1

Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach

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

Experimental: group 2

group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach

Procedure: ultrasound-guided posterior hydrodilatation

Other: guided stretching and strengthening exercise program

guided stretching and strengthening exercise program

Outcome Measures

Primary Outcome Measures

visual analoge state [3 months]
minimum value: 0 maximum value: 10 higher scores mean a worse outcome.
shoulder pain and disability index [3 months]
minimum value: 0 maximum value: 100 higher scores mean a worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Tanta	Gharbia	Egypt	31527

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammed Hassan Abu-Zaid, associate professor, Tanta University

ClinicalTrials.gov Identifier:

NCT05194852

Other Study ID Numbers:

hydro1

First Posted:

Jan 18, 2022

Last Update Posted:

Jan 18, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Bursitis

Anesthetics

Anesthetics, Local

Study Results

No Results Posted as of Jan 18, 2022