Ultrasound Guided Shoulder Intra-Articular Ozone Injection Versus Pulsed Radiofrequency Application for Shoulder Adhesive Capsulitis

July 6, 2022 updated by: Ahmed Foula

Ultrasound Guided Shoulder Intra-Articular Ozone Injection Versus Pulsed Radiofrequency Application for Shoulder Adhesive Capsulitis - A Randomized Controlled Clinical Study

The aim of this study is to evaluate the efficacy of the ultrasound guided shoulder intra-articular Ozone injection versus pulsed radiofrequency application in patients with shoulder adhesive capsulitis.

  • Primary Outcome :

    - Pain score using visual analogue scale during rest (VASr) and movement (VASm).

  • Secondary Outcome :

    • Quality of life using Shoulder Pain and Disability Index (SPADI). It assesses the overall functionality of the shoulder joint.
    • Levels of serum ICAM -1, and serum high sensitive C-reactive protein (hs-CRP) are compared before and after treatment intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After approval of the local ethical committee of Medical Research Institute - Alexandria University (IORG0008812), an informed written consent will be taken from all patients participating in the study. The study will be carried out on 45 adult patients (15 per group) of either gender, aged from 30 to 65 years. Eligible patients are those who were diagnosed with primary shoulder adhesive capsulitis according to the previously mentioned diagnostic criteria, with history of inadequate response to a trial of conservative therapy (NSAIDs and physiotherapy) for at least four weeks.

Patients will be assigned into three equal groups using computerized random blocks method:

  1. Steroid Group (S): [15 patients] Control group treated with intra-articular injection of 5 ml of Bupivacaine 0.125% added to triamcinolone 40 mg under the ultrasound guidance.
  2. Ozone Group (O3): [15 patients] Patients will be treated with intra-articular injection of 5 ml of Bupivacaine 0.125% followed by injection of 10 ml of Oxygen-Ozone mixture (15 μg/ml) under the ultrasound guidance.
  3. Pulsed radiofrequency Group (PRF): [15 patients] Patients will be treated with shoulder intra-articular injection of 5 ml of Bupivacaine 0.125% followed by pulsed radiofrequency application under the ultrasound guidance.

Patients' Evaluation and Preparation:

Patients' preparation starts with pre-intervention evaluation visit. Proper history taking and clinical examination will be carried out. Documentation of the range of motion and VAS score will be done after proper explanation. Patients will be asked to fill a SPADI score form.

Laboratory investigations will include complete blood count (CBC), prothrombin time (PT), and international normalized ratio (INR).

Baseline serum ICAM-1 level and hs-CRP level will be measured using 5 ml of patient's venous blood.

Patients will be asked to sign a consent form to participate in the study. Participants will be admitted to pain management ward. Random assignment will be carried out using computerized random blocks with variable block size.

All interventions will be carried out in the operating theatre (OR) for proper monitoring and sterilization procedures. A 20 G intravenous (IV) cannula will be inserted for all patients in the OR. Basic monitoring will be applied; continuous electrocardiogram (ECG) monitoring, arterial Oxygen saturation (SPO2) monitoring, and non-invasive blood pressure (NIBP) monitoring.

Intervention Methodology:

  1. Group S:

    Patients will be put in lateral semi-prone position with the affected shoulder facing up. Shoulder space will be opened by arm internal rotation and adduction across the chest. Under sterile conditions and proper draping of the affected shoulder, scanning will start using Sonosite® M- turbo™ ultrasound machine. A high frequency linear probe (7-14 MHz) will be put parallel and just inferior to spine of the scapula. Identification of humeral head, joint capsule, labrum, glenoid, and infraspinatus and deltoid muscles should be available in one image to avoid wrong needle positioning. The in-plane posterior approach for intra-articular injection will be used (Furman et al., 2017). Needle insertion (22 Gauge, 5 cm length) approach from inferomedial to superolateral direction towards the humeral head. The targeted needle path should avoid labrum puncture. The end point for injection is subcapsular and adjacent to the labrum.

    After confirmation of proper needle position, 5 ml of Bupivacaine 0.125% will be injected added to triamcinolone 40 mg (Babaei-Ghazani et al., 2019).

  2. Group O3:

    Under the previously described position and scanning technique, intra-articular injection of 5 ml of Bupivacaine 0.125% followed by 10 ml of Oxygen-Ozone mixture (15 μg/ml) will be done (Noori-Zadeh et al., 2019).

  3. Group PRF:

Under the previously described position and scanning technique, 5 ml of Bupivacaine 0.125% will be directly injected. Following, Intra-articular PRF will be applied with a 10 cm neurotherm needle with 10 mm active tip for 4 minutes to the glenohumeral joint (Ozyuvaci et al., 2011).

Post-Procedure Assessment:

All participants will be treated as day-case patients and will be observed in the recovery ward for 2 h after therapy. VAS, shoulder joint ROM, and any complication (e.g., hematoma formation, vasovagal attack, etc.) will be recorded before discharge.

Follow-up visits will be planned for all participants at week 1, 2, 4, 8 post-intervention. During these visits, reassessment will be done for VASr, VASm, SPADI score, and ROM.

  • Pain score Using visual analogue scale during rest (VASr) and movement (VASm), pain will be categorized as mild (0-3), moderate (4-6), or severe (7-10). Improved pain score is considered significant when there is a categorical improvement in pain level.
  • Quality of life Using Shoulder Pain and Disability Index (SPADI), improvement in quality of life is considered significant when there is 10% reduction in the final index.

During the last follow-up visit, samples for serum ICAM-1 and highly sensitive CRP levels will be obtained.

Statistical Analysis:

Data will be analyzed using descriptive statistical methods as well as comparison of the qualitative and quantitative data. Presentation will be carried out in the form of proper tables and graphical presentation.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Medical Research Institute - Alexandria University

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

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged from 30 to 65 years
  • Either gender
  • Diagnosed with Adhesive Capsulitis
  • Inadequate response for conservative therapy (NSAIDs and physiotherapy) for four weeks

Exclusion Criteria:

  • Patients diagnosed with central post-stroke neuropathic pain
  • Patients with documented rheumatoid arthritis
  • Patients with current shoulder fracture or trauma
  • Known causes for secondary adhesive capsulitis (e.g., diabetes)
  • Patients with local tumor at shoulder region
  • Patients with local skin infection over shoulder region
  • Patients with reported coagulopathy
  • Patients with allergy to LA

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Steroid Group
shoulder intra-articular injection of 5 ml of Bupivacaine 0.125% added to triamcinolone 40 mg under the ultrasound guidance
Procedure: Steroid Group
Ultrasound guided shoulder intra-articular steroid injection
Active Comparator: Ozone Group
shoulder intra-articular injection of 5 ml of Bupivacaine 0.125% followed by injection of 10 ml of Oxygen-Ozone mixture (15 µg/ml) under the ultrasound guidance
Procedure: Ozone Group
Ultrasound guided shoulder intra-articular Ozone injection
Active Comparator: PRF Group
shoulder intra-articular injection of 5 ml of Bupivacaine 0.125% followed by pulsed radiofrequency application under the ultrasound guidance
Procedure: PRF Group
Ultrasound guided shoulder intra-articular pulsed radiofrequency application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score, using Visual Analogue Scale (VAS)
Time Frame: Initial assessment visit + Immediate post-intervention + Follow-up visits will be planned at week 1, 2, 4, 8 post-intervention.
Visual analogue scale during rest (VASr) and movement (VASm), pain will be categorized as mild (0-3), moderate (4-6), or severe (7-10). Change in pain score is considered significant when there is a categorical shift in pain level.
Initial assessment visit + Immediate post-intervention + Follow-up visits will be planned at week 1, 2, 4, 8 post-intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QOL improvement, using Shoulder Pain And Disability Index (SPADI)
Time Frame: Initial assessment visit + Immediate post-intervention + Follow-up visits will be planned at week 1, 2, 4, 8 post-intervention.
Assesses the overall functionality of the shoulder joint. Using SPADI score, change in QOL is considered significant when there is 10% change in the final index.
Initial assessment visit + Immediate post-intervention + Follow-up visits will be planned at week 1, 2, 4, 8 post-intervention.
Systemic inflammatory markers, using serum Intracellular Adhesion Molecule (ICAM 1) level.
Time Frame: Immediate pre-intervention (baseline) + 8 weeks post-intervention (last follow-up visit).
Levels of serum ICAM -1 are compared before intervention and at the end of follow-up period.
Immediate pre-intervention (baseline) + 8 weeks post-intervention (last follow-up visit).
Systemic inflammatory markers, using serum High Sensitive C Reactive Protein (hs-CRP) level.
Time Frame: Immediate pre-intervention (baseline) + 8 weeks post-intervention (last follow-up visit).
Levels of serum high sensitive C Reactive Protein (hs-CRP) are compared before intervention and at the end of follow-up period.
Immediate pre-intervention (baseline) + 8 weeks post-intervention (last follow-up visit).

Collaborators and Investigators

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

Sponsor

Ahmed Foula

Investigators

  • Study Director: Laila S. Sabry, MD, Department of Anaesthesia and Pain Medicine - Medical Research Institute - Alexandria University
  • Study Director: Ahmed F. Elmulla, MD, Department of Anaesthesia and Pain Medicine - Medical Research Institute - Alexandria University
  • Study Director: Maher A. Kamel, MD, Department of Biochemistry - Medical Research Institute - Alexandria University
  • Study Director: Adel I. Hozein, MD, Department of Anaesthesia and Pain Medicine - Medical Research Institute - Alexandria 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

Helpful Links

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 (Actual)

January 5, 2021

Primary Completion (Actual)

June 10, 2022

Study Completion (Actual)

June 10, 2022

Study Registration Dates

First Submitted

January 16, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 6, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1216-4-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD collected can be shared with other researchers in other studies as decided by the main investigator. Personal data will never be shared.

IPD Sharing Time Frame

Data will be available once be collected and reported in study database.

IPD Sharing Access Criteria

All IPD collected can be shared with other researchers in other studies as decided by the main investigator. Personal data will never be shared.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

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

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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