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

• Sponsor: Pamukkale University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05318560
• Collaborator: (none)
• Enrollment: 72
• Arms: 3
• Anticipated Duration (Months): 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myofascial Pain Syndrome; Ozone	Drug: Lidocaine 2% Injectable Solution; Drug: Ozone; Other: stretching exercise	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of the Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome
• Anticipated Study Start Date: Jun 30, 2022
• Anticipated Primary Completion Date: Sep 10, 2022
• Anticipated Study Completion Date: Dec 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Lidocaine 2% Injectable Solution; for MPS; Other Names: jetokain simplex ; Other: stretching exercise; for MPS
Active Comparator: 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.	Drug: Ozone; for MPS; Other: stretching exercise; for MPS
Active Comparator: 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.	Other: stretching exercise; for MPS

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pamukkale University

Investigators

• Study Director: Hakan Alkan, Prof., Pamukkale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hakan Alkan, Clinical Professor, Pamukkale University
• ClinicalTrials.gov Identifier: NCT05318560
• Other Study ID Numbers: PamukkaleU-Simsek-003
• First Posted: Apr 8, 2022
• Last Update Posted: Jun 23, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hakan Alkan, Clinical Professor, Pamukkale University: Ozone; Pain
• Additional relevant MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome; Somatoform Disorders; Lidocaine

Study Results

No Results Posted as of Jun 23, 2022