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

The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome: A Prospective Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain Syndrome; Myofascial Trigger Point Pain
• Intervention / Treatment: Procedure: Ozone therapy; Procedure: Lidocaine injection group

Detailed Description

The study was designed as a prospective, randomized, controlled trial. Fourty six people who met the inclusion criteria will randomized into two groups of 23 people. The first group will be designated as ozone therapy group and patients in the second group will be designated as the lidocaine injection group. Patients will be evaluated with visuel analog scale (10cm-VAS), Neck Disability Index (NDI), Pain Score (PS) and neck lateral flexion measurement before and after treatment at 4 and 12 weeks.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ozone therapy group; Patients with myofascial pain syndrome receiving ozone injection	Procedure: Ozone therapy; 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.
ACTIVE_COMPARATOR: Lidocaine injection group; Patients with myofascial pain syndrome receiving lidocaine injection	Procedure: Lidocaine injection group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability Index (NDI)	Neck Disability Index (NDI) is a self-report 10-item questionnaire used to evaluate the effect of neck pain on daily living activities. Each item is scored from 0 to 5. Higher scores of NDI indicate more disability and pain.	baseline, change from baseline NDI at 4 and 12 after injection
Pain Scor (PS)	Pain Scor (PS) measures the severity of pain felt at the trigger point by placing the thumb to the skin covering the muscle containing the trigger point in a perpendicular fashion and exerting pressure until there was whitening of the nail bed.	baseline, change from baseline PS at 4 and 12 weeks after injection
Range of Motion (ROM) of the neck	Passive ROM measurements of the neck lateral flexion movements were recorded by a universal goniometer.	baseline, change from baseline ROM at 4 and 12 weeks after injection

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Investigators: Principal Investigator: Nurdan Korkmaz, MD, Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, Department of PMR

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2021
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: May 8, 2021
• First Submitted That Met QC Criteria: May 8, 2021
• First Posted (ACTUAL): May 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: lidocaine; myofascial pain syndrome; ozone; trigger point pain
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No