Ultrasound-guided Anterior Hydrodilatation in Shoulder Adhesive Capsulitis

NCT ID: NCT05194852

Last Updated: 2022-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2018-09-28

Brief Summary

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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

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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.

Conditions

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Shoulder Capsulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
the participants and outcome assessor didn't know the group classification

Study Groups

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group 1

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

Group Type ACTIVE_COMPARATOR

ultrasound-guided posterior hydrodilatation

Intervention Type PROCEDURE

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

corticosteroid, saline, and local anesthetic

Intervention Type DRUG

corticosteroid, saline, and local anesthetic

guided stretching and strengthening exercise program

Intervention Type OTHER

guided stretching and strengthening exercise program

group 2

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

Group Type EXPERIMENTAL

ultrasound-guided posterior hydrodilatation

Intervention Type PROCEDURE

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

guided stretching and strengthening exercise program

Intervention Type OTHER

guided stretching and strengthening exercise program

Interventions

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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

Intervention Type PROCEDURE

corticosteroid, saline, and local anesthetic

corticosteroid, saline, and local anesthetic

Intervention Type DRUG

guided stretching and strengthening exercise program

guided stretching and strengthening exercise program

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Hassan Abu-Zaid

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine

Tanta, Gharbia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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hydro1

Identifier Type: -

Identifier Source: org_study_id

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