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

NCT04724317 | Completed DMC

• 1 other identifier: 1216-4-010
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adhesive Capsulitis; Shoulder Pain

Keywords

adhesive capsulitis; soulder pain; triamcinolone; ozone; pulsed radiofrequency

Outcome Measures

Primary Outcomes (1)

• Pain score, using Visual Analogue Scale (VAS)

  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 Outcomes (3)

• QOL improvement, using Shoulder Pain And Disability Index (SPADI)

  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.

  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.

  Immediate pre-intervention (baseline) + 8 weeks post-intervention (last follow-up visit).

Study Arms (3)

Steroid Group

SHAM COMPARATOR

shoulder intra-articular injection of 5 ml of Bupivacaine 0.125% added to triamcinolone 40 mg under the ultrasound guidance

Procedure: Steroid Group

Ozone Group

ACTIVE COMPARATOR

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

PRF Group

ACTIVE COMPARATOR

shoulder intra-articular injection of 5 ml of Bupivacaine 0.125% followed by pulsed radiofrequency application under the ultrasound guidance

Procedure: PRF Group

Interventions

Steroid Group PROCEDURE

Ultrasound guided shoulder intra-articular steroid injection

Steroid Group

Ozone Group PROCEDURE

Ultrasound guided shoulder intra-articular Ozone injection

Ozone Group

PRF Group PROCEDURE

Ultrasound guided shoulder intra-articular pulsed radiofrequency application

PRF Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahmed Foula: lead

Study Sites (1)

Medical Research Institute - Alexandria University

Alexandria, Egypt

Location

Related Publications (18)

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  PMID: 31188145 BACKGROUND

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  PMID: 32491803 BACKGROUND

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  PMID: 6742896 BACKGROUND

• Chang LR, Anand P, Varacallo MA. Anatomy, Shoulder and Upper Limb, Glenohumeral Joint. 2025 Mar 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537018/

  PMID: 30725703 BACKGROUND

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• Kim YS, Kim JM, Lee YG, Hong OK, Kwon HS, Ji JH. Intercellular adhesion molecule-1 (ICAM-1, CD54) is increased in adhesive capsulitis. J Bone Joint Surg Am. 2013 Feb 20;95(4):e181-8. doi: 10.2106/JBJS.K.00525.

  PMID: 23426775 BACKGROUND

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  PMID: 23489372 BACKGROUND

• Neviaser AS, Neviaser RJ. Adhesive capsulitis of the shoulder. J Am Acad Orthop Surg. 2011 Sep;19(9):536-42. doi: 10.5435/00124635-201109000-00004.

  PMID: 21885699 BACKGROUND

• Noori-Zadeh A, Bakhtiyari S, Khooz R, Haghani K, Darabi S. Intra-articular ozone therapy efficiently attenuates pain in knee osteoarthritic subjects: A systematic review and meta-analysis. Complement Ther Med. 2019 Feb;42:240-247. doi: 10.1016/j.ctim.2018.11.023. Epub 2018 Nov 28.

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• Ozyuvaci E, Akyol O, Acikgoz A, Leblebici H. Intraarticular pulsed mode radiofrequency lesioning of glenohumeral joint in chronic shoulder pain: 3 cases. Korean J Pain. 2011 Dec;24(4):239-41. doi: 10.3344/kjp.2011.24.4.239. Epub 2011 Nov 30. No abstract available.

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Related Links

• Atlas of Image-Guided Spinal Procedures E-Book

MeSH Terms

Conditions

Bursitis; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: January 26, 2021
• Study Start: January 5, 2021
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available once be collected and reported in study database.
• 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.

Locations

EG (1)