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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozone therapy group | Active Comparator | Patients with myofascial pain syndrome receiving ozone injection |
|
| Lidocaine injection group | Active Comparator | Patients with myofascial pain syndrome receiving lidocaine injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozone therapy | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nurdan Korkmaz, MD | Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, Department of PMR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaziler Physical Medicine and Rehabilitation Education and Research Hospital | Ankara | 06800 | Turkey (Türkiye) |
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| Lidocaine injection group | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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