NCT06768281

Effect of Lidocaine and Ozone in Injection for Myofascial Pain

Comparison of the Efficacy of Lidocaine and Ozone in Masticatory Muscle Injections for Patients With Myofascial Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Yağmur Malkoc · Academic / Other
• Sex: All
• Age: 17 Years – 42 Years
• Healthy volunteers: Accepted

Summary

Myofascial pain syndrome (MPS) is a chronic soft tissue rheumatism characterized by tense, painful muscle bands, known as trigger points, located within the muscle or fascia. These trigger points typically lead to pain during movement, limiting muscle extension and reducing mobility. While various treatments exist for MPS, the most common approach is injecting local anesthetic agents directly into the trigger points to relieve pain. Recently, systemic and local ozone therapy has also gained popularity as an alternative treatment for MPS. Ozone can be injected directly into muscles in areas such as the back and waist to target pain and inflammation. The aim of this study is to investigate the clinical effectiveness of ozone therapy with lidocaine injection in patients diagnosed with MPS.The aim of this study was to compare 2% non-vasoconstrictor lidocaine and ozone injections in the treatment of patients presenting to the clinic with myofascial pain syndrome and to determine the more therapeutic method.

Detailed description

60 patients between the ages of 18-65 diagnosed with MPS were included in the study. The patients were randomly divided into four groups. As the control group, the first group was injected with isotonic saline, the second group was injected with 2% lidocaine without vasoconstrictor, the third group was injected with ozone gas and the fourth group was injected with ozonated isotonic saline. Patients were evaluated with VAS score before treatment, at 1, 2, 4 weeks and 3 months after treatment. In addition, quality of life was evaluated with HIT-6 and Pittsburgh Sleep Quality Index (PSQI) scales before treatment and at the 1st and 3rd months after treatment.

Conditions

• Myofascial Pain Syndromes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Headache Impact Test-6 (HIT-6)	Patients who had injections were asked to mark their headache severities with a survey includes six questions about their past 4 weeks. The test applied preoperatively, postoperatively 1st and 3rd months.
DIAGNOSTIC_TEST	Pittsburgh Sleep Quality Index (PSQI)	Patients who had injections were asked to reply some questions about their sleeping habits for past 4 weeks. The test applied preoperatively, postoperatively 1st and 3rd months.
DIAGNOSTIC_TEST	Visual Analogue Score (VAS)	Patients who had injections are asked to state their pain with a 10 cm visual analogue scale preoperatively and postoperatively 1st,2nd weeks and 1st and 3rd months.
OTHER	Masseter muscle injection	1 ml of insulin needle with a 27-gauge ½ inch 13 mm needle tip will be injected into up to 4 trigger points in the taut bands that cause the most pain in the masseter muscle. Injections were done at most 3 times. As the control group, the first group was injected with isotonic saline; the second group was injected with 2% lidocaine without vasoconstrictor; the third group with ozone gas; and the fourth group with ozonated isotonic saline.

Timeline

• Start date: 2021-03-25
• Primary completion: 2024-01-14
• Completion: 2024-09-27
• First posted: 2025-01-10
• Last updated: 2025-01-10

Locations

1 site across 1 country: Turkey (Türkiye)