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

Myofascial Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04885881
• Other study ID #: 14
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2022
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Myofascial Trigger Point Pain
• Somatoform Disorders
• Syndrome

Intervention

Procedure:
• Ozone 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.
• Lidocaine 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.

Locations

Country	Name	City	State
Turkey	Gaziler Physical Medicine and Rehabilitation Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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