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

NCT ID: NCT04885881

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2021-12-01

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.

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.

Conditions

Myofascial Pain Syndrome; Myofascial Trigger Point Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ozone therapy group

Patients with myofascial pain syndrome receiving ozone injection

Group Type: ACTIVE_COMPARATOR

Ozone therapy

Intervention Type: 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.

Lidocaine injection group

Patients with myofascial pain syndrome receiving lidocaine injection

Group Type: ACTIVE_COMPARATOR

Lidocaine injection group

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yasin Demir

Physical Medicine and Rehabilitation Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nurdan Korkmaz, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

14

Identifier Type: -

Identifier Source: org_study_id