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

Myofascial Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05318560
• Other study ID #: PamukkaleU-Simsek-003
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: December 10, 2022

Study information

• Verified date: June 2022
• Source: Pamukkale University
• Contact: Ayse Simsek, m.d.
• Phone: +905319698492
• Email: draysesimsek2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 10, 2022
• Est. primary completion date: September 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Ozone
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• Lidocaine 2% Injectable Solution
for MPS
• Ozone
for MPS

Other:
• stretching exercise
for MPS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline VAS at the 1st week after the treatment.
Secondary	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.	Change from baseline VAS at the 1st week after the treatment.
Secondary	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.	Change from baseline VAS at the 1st week after the treatment.