Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome

NCT ID: NCT05318560

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2022-12-10

Brief Summary

In this study, the investigators planned to compare local anesthetic injection added to stretching exercise, ozone injection treatment added to stretching exercise, and only stretching exercise in patients with upper trapezius muscle myofascial pain syndrome.

Detailed Description

The investigators will recruit 72 patients with at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of myofascial pain syndrome (MAS) (according to Travell-Simons' criteria) admitted to the physical medicine and rehabilitation outpatient clinic.

Age, gender, occupation, medications, duration of diagnosis, body mass index, comorbidity, functional status and pain of these patients will be questioned. Patients will be randomly divided into three groups. A total of 3 consecutive weeks of treatment were planned.

Conditions

Myofascial Pain Syndrome; Ozone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Local anesthetic injection

Patients will be injected with lidocaine and given upper trapezius muscle stretching exercises. Lidocaine injection 2cc 2% will be administered to all patients using a 26 gauge, 0.45x13 mm disposable sterile needle to the affected trigger point.

Group Type: ACTIVE_COMPARATOR

Lidocaine 2% Injectable Solution

Intervention Type: DRUG

for MPS

stretching exercise

Intervention Type: OTHER

for MPS

Ozone injection

Ozone injection will be performed on patients and upper trapezius muscle stretching exercises will be given. 8 cc of oxygen/ozone gas at a concentration of 15 µg/mL will be injected into the trigger point.

Group Type: ACTIVE_COMPARATOR

Ozone

Intervention Type: DRUG

for MPS

stretching exercise

Intervention Type: OTHER

for MPS

Stretching exercise

Patients will be given a home program that includes upper trapezius muscle stretching exercises. Upper trapezius stretching exercises will be performed twice a day for at least 15 seconds, ten sets each time, for three weeks, with one hand on the patient's back and the other hand holding the side of the head and tilting it to the side until a slight tension is felt. The exercises will be explained in the text, visual and verbal forms with the exercise form.

Group Type: ACTIVE_COMPARATOR

stretching exercise

Intervention Type: OTHER

for MPS

Interventions

Lidocaine 2% Injectable Solution

for MPS

Intervention Type: DRUG

Ozone

for MPS

Intervention Type: DRUG

stretching exercise

for MPS

Intervention Type: OTHER

Other Intervention Names

jetokain simplex

Eligibility Criteria

Inclusion Criteria

• With at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of MPS

Exclusion Criteria

• Presence of any cervical radiculopathy or a history of degenerative conditions
• Presence of any cervical surgery or trauma in the past year,
• History of injection for the treatment of MAS in the last 6 months,
• Cognitive disorder,
• Rheumatological disease, fibromyalgia,
• History of metabolic diseases such as hypothyroidism and diabetes mellitus

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Hakan Alkan

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hakan Alkan, Prof.

Role: STUDY_DIRECTOR

Pamukkale University

Central Contacts

Ayse Simsek, m.d.

Role: CONTACT

draysesimsek2@gmail.com

+905319698492

Hakan Alkan, Prof.

Role: CONTACT

Other Identifiers

PamukkaleU-Simsek-003

Identifier Type: -

Identifier Source: org_study_id