The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome
- Conditions
- Myofascial Trigger Point PainMyofascial Pain Syndrome
- Interventions
- Procedure: Lidocaine injection groupProcedure: Ozone therapy
- Registration Number
- NCT04885881
- Lead Sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lidocaine injection group Lidocaine injection group Patients with myofascial pain syndrome receiving lidocaine injection Ozone therapy group Ozone therapy Patients with myofascial pain syndrome receiving ozone injection
- Primary Outcome Measures
Name Time Method Neck Pain baseline, change from baseline VAS at 4 and 12 weeks after injection 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
- Secondary Outcome Measures
Name Time Method Pain Scor (PS) baseline, change from baseline PS at 4 and 12 weeks after injection 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.
Range of Motion (ROM) of the neck baseline, change from baseline ROM at 4 and 12 weeks after injection Passive ROM measurements of the neck lateral flexion movements were recorded by a universal goniometer.
Neck Disability Index (NDI) baseline, change from baseline NDI at 4 and 12 after injection 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.
Trial Locations
- Locations (1)
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
🇹🇷Ankara, Turkey