Back to resultsEfficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome
Primary Purpose
Myofascial Pain Syndrome, Ozone
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lidocaine 2% Injectable Solution
Ozone
stretching exercise
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Ozone, Pain
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Local anesthetic injection
Ozone injection
Stretching exercise
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05318560
Brief Title
Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome
Official Title
Comparison of the Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 30, 2022 (Anticipated)
Primary Completion Date
September 10, 2022 (Anticipated)
Study Completion Date
December 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome, Ozone
Keywords
Ozone, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Local anesthetic injection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ozone injection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Stretching exercise
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Lidocaine 2% Injectable Solution
Other Intervention Name(s)
jetokain simplex
Intervention Description
for MPS
Intervention Type
Drug
Intervention Name(s)
Ozone
Intervention Description
for MPS
Intervention Type
Other
Intervention Name(s)
stretching exercise
Intervention Description
for MPS
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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 Outcome Measure Information:
Title
Neck Disability Index (NDI)
Description
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.
Title
Range of motion (ROM)
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayse Simsek, m.d.
Phone
+905319698492
Email
draysesimsek2@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hakan Alkan, Prof.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakan Alkan, Prof.
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome
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