Ultrasound Guided Shoulder Anterior Capsular Infiltration Plus Hydrodilatation With Steroid Versus Hyalase in Patients With Frozen Shoulder

November 8, 2023 updated by: Ahmed Yehia Mohamed, Assiut University
To compare ultrasound-guided shoulder anterior capsular infiltration plus hydrodilatation with a steroid versus hyalase in patients with frozen shoulders

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Frozen shoulder (FS) is a self-limiting pathology of the shoulder joint causing restriction in both the active and passive range of movements associated with pain (Konarski et al., 2020).

A frozen shoulder is a common condition causing severe pain and a reduced range of motion in the shoulder. It can result in detrimental effects on quality of life and the ability to perform activities of daily living (ADLs). It affects 2% to 5% of the global population and is more common in diabetic patients. There are a variety of treatment options available for patients with frozen shoulders as part of the management ladder of interventions. FS may persist for more than three years or may never resolve (Sam et al., 2023).

Conservative management includes physiotherapy, NSAIDs, Hydrodilatation (HD), intra-articular steroids, manipulation under anesthesia, and arthroscopic, or open capsular release. Distension of the shoulder capsule with normal saline and steroid infusion has been suggested to benefit by changing the biochemical properties of the capsule in FS (Cho et al., 2019).

Hydrodilatation of the shoulder joint capsule was a novel treatment to alleviate the pain of the affected shoulder. The procedure may be given with or without an adjuvant corticosteroid. Hydrodilatation, using saline and a corticosteroid, was superior in short-term pain reduction and range of motion improvement compared to management using only physiotherapy and corticosteroid injection in patients treated for frozen shoulder (Prasetia et al., 2022).

The proposed hypothesis regarding the mechanism of action in hydrodilatation and pain reduction in patients with frozen shoulder was associated with synovitis and fibrosis removal. Previous studies also noted better pain reduction in patients receiving hydrodilatation with adjuvant corticosteroid than only corticosteroid injection (Albana et al., 2022).

Several other adjuvants were studied in frozen shoulder treatment using hydrodilatation. The hydrodilatation method can cause pain in the shoulder during the intervention, so early manual exercise after the intervention is required to inhibit pain (Wang et al., 2021).

Hyaluronidases are a family of enzymes that catalyze the degradation of hyaluronic acid. By catalyzing the hydrolysis of hyaluronan, a constituent of the extracellular matrix, hyaluronidase lowers the viscosity of hyaluronan, thereby increasing the tissue permeability of injected solutes (Lee et al., 2021).

Accordingly, hyaluronidase is used in medicine in conjunction with other drugs, including steroids, to speed their dispersion and delivery. There is growing evidence that using a steroid in combination with hyaluronidase in shoulder joints or spinal epidural spaces both maximizes the anti-inflammatory properties of the steroid and minimizes the side effects of steroid therapy (Manna et al., 2020).

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:1- Patients diagnosed with unilateral frozen shoulder. 2- Diagnosis of frozen shoulder will be based on clinical examination (restriction of passive external rotation in the affected shoulder > 50% compared to the opposite side), in the presence of normal plain radiographs (anteroposterior and axillary projections other than calcific tendinopathy).

3- Patients with symptoms for more than three months but less than one year which has not improved with medications and physiotherapy.

4- aged 30 to 70 years old

Exclusion Criteria:

  1. History of trauma to the shoulder.
  2. History of fracture or dislocation around the shoulder.
  3. Inflammatory arthritis
  4. coagulation disorders
  5. History of previous injections within three months.
  6. Cervical radiculopathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A shoulder anterior capsular infiltration plus hydrodilatation with steroids.
25 patients with frozen shoulders treated with ultrasound-guided shoulder anterior capsular infiltration plus hydrodilatation with steroids.
Procedure: hydrodilatation with steroid in group A versus hyalase in group B

Hydrodilatation technique:

the ultrasound transducer will be placed on the posterior surface of the shoulder in the longitudinal plane to identify the posterior glenohumeral joint, bony glenoid, humeral head, and infraspinatus muscle.Then, after sterilizing the area to be injected, the needle will be advanced to the target point between the humeral head cartilage and the infraspinatus tendon using the ultrasound-guided in-plane technique.To ensure the injection into the glenohumeral joint, the Doppler mode will be used to confirm the widening of the space between the humeral cartilage and the innermost synovial line of the infraspinatus muscle by the injected solution.
Active Comparator: groupB shoulder anterior capsular infiltration plus hydrodilatation with hyalase.
25 patients with frozen shoulders treated with ultrasound-guided shoulder anterior capsular infiltration plus hydrodilatation with hyalase.
Procedure: hydrodilatation with steroid in group A versus hyalase in group B

Hydrodilatation technique:

the ultrasound transducer will be placed on the posterior surface of the shoulder in the longitudinal plane to identify the posterior glenohumeral joint, bony glenoid, humeral head, and infraspinatus muscle.Then, after sterilizing the area to be injected, the needle will be advanced to the target point between the humeral head cartilage and the infraspinatus tendon using the ultrasound-guided in-plane technique.To ensure the injection into the glenohumeral joint, the Doppler mode will be used to confirm the widening of the space between the humeral cartilage and the innermost synovial line of the infraspinatus muscle by the injected solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Shoulder Pain and Disability Index (SPADI)
Time Frame: baseline and 3 weeks, 3 months, and 12 months after the intervention
The Shoulder Pain and Disability Index (SPADI) will be used to evaluate pain and disability at baseline and 3 weeks, 3 months, and 12 months after the intervention
baseline and 3 weeks, 3 months, and 12 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 25, 2023

Primary Completion (Estimated)

May 24, 2025

Study Completion (Estimated)

December 5, 2026

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Estimated)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Frozen shoulder

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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