Ultrasound-guided Anterior Hydrodilatation in Shoulder Adhesive Capsulitis

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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Capsulitis
• Intervention / Treatment: Procedure: ultrasound-guided posterior hydrodilatation; Drug: corticosteroid, saline, and local anesthetic; Other: guided stretching and strengthening exercise program

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 31527
      • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analoge state	minimum value: 0 maximum value: 10 higher scores mean a worse outcome.	3 months
shoulder pain and disability index	minimum value: 0 maximum value: 100 higher scores mean a worse outcome.	3 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): September 28, 2018

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: hydro1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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