Effect of Lidocaine and Ozone in Injection for Myofascial Pain

Yağmur Malkoc

Status: Completed

Conditions: Myofascial Pain Syndromes

Treatments: Diagnostic Test: Visual Analogue Score (VAS); Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI); Diagnostic Test: Headache Impact Test-6 (HIT-6); Other: Masseter muscle injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06768281

IstanbulMUH-DF-YM-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 17 to 42 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No temporomandibular joint treatment within the last year.
• Presence of palpable trigger points in the unilateral/bilateral masseter muscle.
• Classified as ASA 1 or ASA 2.
• Chronic pain in the masseter muscle for at least the past three months.
• Presence of at least two palpable trigger points in the unilateral or bilateral masseter muscle, with a pain score of ≥ 3 on the Visual Analog Scale (VAS) upon palpation

Exclusion criteria

• History of allergy to any anesthetic agent.
• Use of anticoagulant medications.
• Use of analgesics, muscle relaxants, or antidepressants within the last month.
• Diagnosed with specific conditions such as migraine, neuromuscular junction disorders, fibromyalgia, depression, or schizophrenia.
• History of trauma, tumor, or surgery in the head-neck region.
• Presence of skin infection in the relevant area.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Streaming of patients and administration of substances

Experimental group

Description:

60 patients with myofascial pain syndrome who met the inclusion criteria were divided into four groups into isotonic saline, lidocaine, ozone gas and ozonated isotonic saline. Then the injections were done for each group.

Treatment:

Other: Masseter muscle injection

Diagnostic Test: Headache Impact Test-6 (HIT-6)

Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI)

Diagnostic Test: Visual Analogue Score (VAS)

Repetition of tests at certain intervals

Experimental group

Description:

Quality of life was evaluated by administering PSQI and HIT-6 tests at postoperative 1st and 3rd months.

Treatment:

Diagnostic Test: Headache Impact Test-6 (HIT-6)

Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI)

Diagnostic Test: Visual Analogue Score (VAS)