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

Not Applicable

• Conditions: Ozone; Myofascial Pain Syndrome
• Interventions: Drug: Lidocaine 2% Injectable Solution; Other: stretching exercise; Drug: Ozone

• Registration Number: NCT05318560
• Lead Sponsor: Pamukkale University

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.

Study Timeline

• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-08
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-23
• Study Start: 2022-06-30
• Primary Completion: 2022-09-10
• Study Completion: 2022-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local anesthetic injection	Lidocaine 2% Injectable Solution	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.
Stretching exercise	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.
Ozone injection	stretching exercise	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.
Local anesthetic injection	stretching exercise	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.
Ozone injection	Ozone	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	Change from baseline VAS at the 1st week after the treatment.	The pain score will be measured using a 10 cm millimetric visual analog scale (VAS), where patients are asked to mark the degree of pain intensity from 0 (no pain) to 10 (worst pain imaginable) before and after treatment.

Secondary Outcome Measures

Name	Time	Method
Neck Disability Index (NDI)	Change from baseline VAS at the 1st week after the treatment.	NDI was assessed by the neck pain questionnaire that included 10 questions regarding the severity of neck pain, its impact on sleeping, driving, etc. Each question was scored from 0 to 5 and the total score was measured from 50 and was finally reported in percent (%). A higher percentage of NDI was an indicator of more disability and pain.
Range of motion (ROM)	Change from baseline VAS at the 1st week after the treatment.	Range of motion (ROM) in neck lateral flexion movement measured according to the maximum angle that the patient could laterally bend his or her neck to the right and left side, using three consecutive times of goniometry and recording maximum value of them. Mean of the highest values of both directions was recorded as the final amount.