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Clinical Trials/NCT05318560
NCT05318560
Unknown
Not Applicable

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

Pamukkale University0 sites72 target enrollmentJune 30, 2022

Overview

Phase
Not Applicable
Intervention
Lidocaine 2% Injectable Solution
Conditions
Myofascial Pain Syndrome
Sponsor
Pamukkale University
Enrollment
72
Primary Endpoint
Visual Analogue Scale (VAS)
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 30, 2022
End Date
December 10, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hakan Alkan

Clinical Professor

Pamukkale University

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

Arms & Interventions

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.

Intervention: Lidocaine 2% Injectable Solution

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.

Intervention: stretching exercise

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.

Intervention: Ozone

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.

Intervention: 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.

Intervention: stretching exercise

Outcomes

Primary Outcomes

Visual Analogue Scale (VAS)

Time Frame: 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 Outcomes

  • Neck Disability Index (NDI)(Change from baseline VAS at the 1st week after the treatment.)
  • Range of motion (ROM)(Change from baseline VAS at the 1st week after the treatment.)

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