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

Study Overview
=================
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.

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

Conditions
-----------------
Myofascial Pain Syndrome, Myofascial Trigger Point Pain

Intervention / Treatment
-----------------
* Procedure: Ozone therapy
* Procedure: Lidocaine injection group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ozone therapy group<br>Patients with myofascial pain syndrome receiving ozone injection | Procedure: Ozone therapy<br>* 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.<br>|
| Active Comparator: Lidocaine injection group<br>Patients with myofascial pain syndrome receiving lidocaine injection | Procedure: Lidocaine injection group<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myofascial pain syndrome, trigger point pain, ozone, lidocaine