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

Pamukkale University72 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myofascial Pain Syndrome Ozone

Interventions

Lidocaine 2% Injectable SolutionDRUG

for MPS

OzoneDRUG

for MPS

stretching exerciseOTHER

for MPS

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Visual Analogue Scale (VAS)

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.

Time frame: Change from baseline VAS at the 1st week after the treatment.

Secondary Outcomes

Neck Disability Index (NDI)

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.

Time frame: Change from baseline VAS at the 1st week after the treatment.

Range of motion (ROM)

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.

Time frame: Change from baseline VAS at the 1st week after the treatment.

Central Contacts

Ayse Simsek, m.d.

CONTACT

+905319698492 draysesimsek2@gmail.com

Hakan Alkan, Prof.

CONTACT

Data from ClinicalTrials.gov

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