- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05318560
Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome
Comparison of the Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ayse Simsek, m.d.
- Phone Number: +905319698492
- Email: draysesimsek2@gmail.com
Study Contact Backup
- Name: Hakan Alkan, Prof.
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
for MPS
Other Names:
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.
|
for MPS
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.
|
for MPS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: 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.
|
Change from baseline VAS at the 1st week after the treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Disability Index (NDI)
Time Frame: 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.
|
Change from baseline VAS at the 1st week after the treatment.
|
Range of motion (ROM)
Time Frame: 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.
|
Change from baseline VAS at the 1st week after the treatment.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hakan Alkan, Prof., Pamukkale University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Disease
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Syndrome
- Fibromyalgia
- Somatoform Disorders
- Myofascial Pain Syndromes
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- PamukkaleU-Simsek-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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