Clinical trial NCT04885881: The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome
Official title: The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Myofascial Trigger Point Pain
Keywords: myofascial pain syndrome
trigger point pain
ozone
lidocaine
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Neck Pain
timeFrame: baseline, change from baseline VAS at 4 and 12 weeks after injection
Secondary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: baseline, change from baseline NDI at 4 and 12 after injection
measure: Pain Scor (PS)
timeFrame: baseline, change from baseline PS at 4 and 12 weeks after injection
measure: Range of Motion (ROM) of the neck
timeFrame: baseline, change from baseline ROM at 4 and 12 weeks after injection
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
affiliation: Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, Department of PMR
name: Nurdan Korkmaz, MD
role: PRINCIPAL_INVESTIGATOR
References: