Myofascial Pain Syndrome, Myofascial Trigger Point Pain
Conditions
Keywords
myofascial pain syndrome, trigger point pain, ozone, lidocaine
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.
Interventions
PROCEDUREOzone 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.
PROCEDURELidocaine 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.
Sponsors
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed