Effect of Lidocaine and Ozone in Injection for Myofascial Pain

January 6, 2025 updated by: Yağmur Malkoc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34083
        • İstanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: Repetition of tests at certain intervals
Quality of life was evaluated by administering PSQI and HIT-6 tests at postoperative 1st and 3rd months.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. The pain assessment after injections
Time Frame: Three months
The primary outcome was the Visual Analog Score (VAS), a simple tool that allows the patient to express pain visually and numerically and is particularly effective in measuring subjective sensations. The patient is asked to choose a number between 0 and 10 indicating the pain level, with 0 indicating the least pain and 10 indicating the most pain.
Three months
2. Headache evaluation after injections
Time Frame: Three months
The second outcome was the Headache Impact Test-6 (HIT-6), which is used to assess headaches. 6 indicates the lowest score, and 13 indicates the highest score.
Three months
3. Sleep quality evaluation after injections
Time Frame: Three months
The third outcome was the Pittsburgh Sleep Quality Index (PSQI), consists of 7 main components and a total of 19 questions. Each component is scored from 0 to 3; the total PSQI score ranges from 0 to 21. High scores indicate a decrease in quality of life while descending scores indicate an increase.
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yağmur Malkoc

Collaborators

Istanbul Medipol University Hospital

Investigators

  • Study Director: ÇAĞRI DELİLBAŞI, PROF., Medipol universitesi diş hastanesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2021

Primary Completion (Actual)

January 14, 2024

Study Completion (Actual)

September 27, 2024

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulMUH-DF-YM-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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