Effect of Lidocaine and Ozone in Injection for Myofascial Pain

NCT06768281 | Completed

• 1 other identifier: IstanbulMUH-DF-YM-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myofascial Pain Syndromes

Keywords

ozone; lidocaine; Myofascial Pain Syndrome

Outcome Measures

Primary Outcomes (3)

• 1. The pain assessment after injections

  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

  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

  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

Study Arms (2)

Streaming of patients and administration of substances

EXPERIMENTAL

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); Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI); Diagnostic Test: Visual Analogue Score (VAS); Other: Masseter muscle injection

Repetition of tests at certain intervals

EXPERIMENTAL

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); Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI); Diagnostic Test: Visual Analogue Score (VAS)

Interventions

Headache Impact Test-6 (HIT-6) 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.

Repetition of tests at certain intervals; Streaming of patients and administration of substances

Pittsburgh Sleep Quality Index (PSQI) 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.

Repetition of tests at certain intervals; Streaming of patients and administration of substances

Visual Analogue Score (VAS) 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.

Repetition of tests at certain intervals; Streaming of patients and administration of substances

Masseter muscle injection 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.

Streaming of patients and administration of substances

Eligibility Criteria

• Age: 17 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yağmur Malkoc: lead
• Istanbul Medipol University Hospital: collaborator

Study Sites (1)

Istanbul Medipol University

Istanbul, Fatih, 34083, Turkey (Türkiye)

Location

Related Publications (3)

• Albagieh H, Aloyouny A, Alshehri N, Alsammahi N, Almutrafi D, Hadlaq E. Efficacy of lidocaine versus mepivacaine in the management of myofascial pain. Saudi Pharm J. 2020 Oct;28(10):1238-1242. doi: 10.1016/j.jsps.2020.08.014. Epub 2020 Aug 28.

  PMID: 33132718 BACKGROUND

• Yilmaz O, Sivrikaya EC, Taskesen F, Pirpir C, Ciftci S. Comparison of the Efficacy of Botulinum Toxin, Local Anesthesia, and Platelet-Rich Plasma Injections in Patients With Myofascial Trigger Points in the Masseter Muscle. J Oral Maxillofac Surg. 2021 Jan;79(1):88.e1-88.e9. doi: 10.1016/j.joms.2020.09.013. Epub 2020 Sep 14.

  PMID: 33045182 BACKGROUND

• Kamanli A, Kaya A, Ardicoglu O, Ozgocmen S, Zengin FO, Bayik Y. Comparison of lidocaine injection, botulinum toxin injection, and dry needling to trigger points in myofascial pain syndrome. Rheumatol Int. 2005 Oct;25(8):604-11. doi: 10.1007/s00296-004-0485-6. Epub 2004 Sep 15.

  PMID: 15372199 BACKGROUND

Related Links

• Clinical Study Report
• Clinical Study Report
• Clinical Study Report

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Officials

• ÇAĞRI DELİLBAŞI, PROF.

  Medipol universitesi diş hastanesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 10, 2025
• Study Start: March 25, 2021
• Primary Completion: January 14, 2024
• Study Completion: September 27, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)