Ultrasound-guided Anterior Hydrodilatation in Shoulder Adhesive Capsulitis

NCT05194852 | Completed DMC

• 1 other identifier: hydro1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Capsulitis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

group 1

ACTIVE COMPARATOR

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

Procedure: ultrasound-guided posterior hydrodilatation; Drug: corticosteroid, saline, and local anesthetic; Other: guided stretching and strengthening exercise program

group 2

EXPERIMENTAL

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

Interventions

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

group 1; group 2

corticosteroid, saline, and local anesthetic DRUG

corticosteroid, saline, and local anesthetic

group 1

guided stretching and strengthening exercise program OTHER

guided stretching and strengthening exercise program

group 1; group 2

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Interventions

Adrenal Cortex Hormones; Sodium Chloride; Anesthetics, Local

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the participants and outcome assessor didn't know the group classification
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 18, 2022
• Study Start: January 2, 2018
• Primary Completion: June 30, 2018
• Study Completion: September 28, 2018
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

EG (1)