Effect of Lidocaine and Ozone in Injection for Myofascial Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-25

Study Completion Date

2024-09-27

Brief Summary

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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.

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Detailed Description

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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

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Myofascial Pain Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Streaming of patients and administration of substances

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.

Group Type EXPERIMENTAL

Headache Impact Test-6 (HIT-6)

Intervention Type DIAGNOSTIC_TEST

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.

Pittsburgh Sleep Quality Index (PSQI)

Intervention Type DIAGNOSTIC_TEST

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.

Visual Analogue Score (VAS)

Intervention Type DIAGNOSTIC_TEST

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.

Masseter muscle injection

Intervention Type OTHER

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.

Repetition of tests at certain intervals

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

Group Type EXPERIMENTAL

Headache Impact Test-6 (HIT-6)

Intervention Type DIAGNOSTIC_TEST

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.

Pittsburgh Sleep Quality Index (PSQI)

Intervention Type DIAGNOSTIC_TEST

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.

Visual Analogue Score (VAS)

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

17 Years

Maximum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes