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

NCT05318560 | Unknown

• 1 other identifier: PamukkaleU-Simsek-003
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myofascial Pain Syndrome; Ozone

Keywords

Ozone; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (3)

Local anesthetic injection

ACTIVE COMPARATOR

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.

Drug: Lidocaine 2% Injectable Solution; Other: stretching exercise

Ozone injection

ACTIVE COMPARATOR

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.

Drug: Ozone; Other: stretching exercise

Stretching exercise

ACTIVE COMPARATOR

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.

Other: stretching exercise

Interventions

Lidocaine 2% Injectable Solution DRUG

for MPS

Also known as: jetokain simplex

Local anesthetic injection

Ozone DRUG

for MPS

Ozone injection

stretching exercise OTHER

for MPS

Local anesthetic injection; Ozone injection; Stretching exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

MeSH Terms

Conditions

Myofascial Pain Syndromes; Pain

Interventions

Lidocaine; Ozone; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Oxygen; Gases; Inorganic Chemicals; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hakan Alkan, Prof.

  Pamukkale University

  STUDY DIRECTOR

Central Study Contacts

Ayse Simsek, m.d.

CONTACT

+905319698492; draysesimsek2@gmail.com

Hakan Alkan, Prof.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 8, 2022
• Study Start: June 30, 2022
• Primary Completion: September 10, 2022
• Study Completion: December 10, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06