Skip to main content
OpenTrials
Completed

NCT Number: NCT05194852

Ultrasound-guided Anterior Hydrodilatation in Shoulder Adhesive Capsulitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shoulder Capsulitis

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Tanta, Gharbia Governorate, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound-guided posterior hydrodilatation

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

Drug

corticosteroid, saline, and local anesthetic

guided stretching and strengthening exercise program

Other

guided stretching and strengthening exercise program

Primary outcomes

  1. visual analoge state

    Time frame: 3 months

    minimum value: 0 maximum value: 10 higher scores mean a worse outcome.

  2. shoulder pain and disability index

    Time frame: 3 months

    minimum value: 0 maximum value: 100 higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2022
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.