The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome

NCT04885881 | Completed

• 1 other identifier: 14
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Ozone (O2-O3) has been used as a supportive therapy in various musculoskeletal diseases such as lumbosacral disc herniation, knee osteoarthritis, meniscus injury, shoulder pathologies.The aim of this study is to investigate the effectiveness of ozone (O2-O3) injection applied to the trigger point in the treatment of myofascial pain syndrome.

Conditions

Myofascial Pain Syndrome; Myofascial Trigger Point Pain

Keywords

myofascial pain syndrome; trigger point pain; ozone; lidocaine

Outcome Measures

Primary Outcomes (1)

• Neck Pain

  Severity of pain was assessed using the standard 10 cm VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end

  baseline, change from baseline VAS at 4 and 12 weeks after injection

Secondary Outcomes (3)

• Neck Disability Index (NDI)

  baseline, change from baseline NDI at 4 and 12 after injection

• Pain Scor (PS)

  baseline, change from baseline PS at 4 and 12 weeks after injection

• Range of Motion (ROM) of the neck

  baseline, change from baseline ROM at 4 and 12 weeks after injection

Study Arms (2)

Ozone therapy group

ACTIVE COMPARATOR

Patients with myofascial pain syndrome receiving ozone injection

Procedure: Ozone therapy

Lidocaine injection group

ACTIVE COMPARATOR

Patients with myofascial pain syndrome receiving lidocaine injection

Procedure: Lidocaine injection group

Interventions

Ozone therapy PROCEDURE

Patients in the ozone therapy group will be treated with ozone (O2-O3) in a volume of 5 ml and a dose of 10 µg / ml for three consecutive weeks in a weekly session to the most painful trigger point.

Ozone therapy group

Lidocaine injection group PROCEDURE

Patients in the lidocaine injection group will be applied to the most painful trigger point in a volume of 2 ml of 1% lidocaine for three consecutive weeks, once a week.

Lidocaine injection group

Eligibility Criteria

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

You may qualify if:

• diagnosed with myofascial pain syndrome according to the criteria defined by Simons et al.
• aged between18-65
• having typical myofascial pain symptoms for at least 3 months

You may not qualify if:

• presence of cervical radiculopathy, cervical myelopathy, severe dyscal or bony degeneration
• presence of a history of neck trauma or surgery in the last year
• presence of trigger point injection for myofascial pain syndrome treatment in the last 3 months
• presence of cognitive impairment, malignant hypertension, G6PDH (Glucose 6- Phosphate Dehydrogenase) deficiency, Graves' disease, chronic recurrent pancreatitis attack, severe thrombocytopenia (platelet value \<50,000 / microliter), cerebrovascular disease in which bleeding is active
• presence of systemic diseases such as fibromyalgia, inflammatory diseases such as rheumatoid arthritis, polyneuropathy, coagulopathy.
• presence of pregnancy and breastfeeding

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Nurdan Korkmaz, MD

  Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, Department of PMR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Associate Professor

Study Record Dates

• First Submitted: May 8, 2021
• First Posted: May 13, 2021
• Study Start: April 15, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

TU (1)