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The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome

Primary Purpose

Myofascial Pain Syndrome, Myofascial Trigger Point Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ozone therapy
Lidocaine injection group
Sponsored by
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring myofascial pain syndrome, trigger point pain, ozone, lidocaine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosed with myofascial pain syndrome according to the criteria defined by Simons et al.
  • aged between18-65
  • having typical myofascial pain symptoms for at least 3 months

Exclusion Criteria:

  • presence of cervical radiculopathy, cervical myelopathy, severe dyscal or bony degeneration
  • presence of a history of neck trauma or surgery in the last year
  • presence of trigger point injection for myofascial pain syndrome treatment in the last 3 months
  • presence of cognitive impairment, malignant hypertension, G6PDH (Glucose 6- Phosphate Dehydrogenase) deficiency, Graves' disease, chronic recurrent pancreatitis attack, severe thrombocytopenia (platelet value <50,000 / microliter), cerebrovascular disease in which bleeding is active
  • presence of systemic diseases such as fibromyalgia, inflammatory diseases such as rheumatoid arthritis, polyneuropathy, coagulopathy.
  • presence of pregnancy and breastfeeding

Sites / Locations

  • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ozone therapy group

Lidocaine injection group

Arm Description

Patients with myofascial pain syndrome receiving ozone injection

Patients with myofascial pain syndrome receiving lidocaine injection

Outcomes

Primary Outcome Measures

Neck Pain
Severity of pain was assessed using the standard 10 cm VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end

Secondary Outcome Measures

Neck Disability Index (NDI)
Neck Disability Index (NDI) is a self-report 10-item questionnaire used to evaluate the effect of neck pain on daily living activities. Each item is scored from 0 to 5. Higher scores of NDI indicate more disability and pain.
Pain Scor (PS)
Pain Scor (PS) measures the severity of pain felt at the trigger point by placing the thumb to the skin covering the muscle containing the trigger point in a perpendicular fashion and exerting pressure until there was whitening of the nail bed.
Range of Motion (ROM) of the neck
Passive ROM measurements of the neck lateral flexion movements were recorded by a universal goniometer.

Full Information

First Posted
May 8, 2021
Last Updated
January 14, 2022
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04885881
Brief Title
The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome
Official Title
The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome: A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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
Ozone (O2-O3) has been used as a supportive therapy in various musculoskeletal diseases such as lumbosacral disc herniation, knee osteoarthritis, meniscus injury, shoulder pathologies.The aim of this study is to investigate the effectiveness of ozone (O2-O3) injection applied to the trigger point in the treatment of myofascial pain syndrome.
Detailed Description
The study was designed as a prospective, randomized, controlled trial. Fourty six people who met the inclusion criteria will randomized into two groups of 23 people. The first group will be designated as ozone therapy group and patients in the second group will be designated as the lidocaine injection group. Patients will be evaluated with visuel analog scale (10cm-VAS), Neck Disability Index (NDI), Pain Score (PS) and neck lateral flexion measurement before and after treatment at 4 and 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome, Myofascial Trigger Point Pain
Keywords
myofascial pain syndrome, trigger point pain, ozone, lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ozone therapy group
Arm Type
Active Comparator
Arm Description
Patients with myofascial pain syndrome receiving ozone injection
Arm Title
Lidocaine injection group
Arm Type
Active Comparator
Arm Description
Patients with myofascial pain syndrome receiving lidocaine injection
Intervention Type
Procedure
Intervention Name(s)
Ozone therapy
Intervention Description
Patients in the ozone therapy group will be treated with ozone (O2-O3) in a volume of 5 ml and a dose of 10 µg / ml for three consecutive weeks in a weekly session to the most painful trigger point.
Intervention Type
Procedure
Intervention Name(s)
Lidocaine injection group
Intervention Description
Patients in the lidocaine injection group will be applied to the most painful trigger point in a volume of 2 ml of 1% lidocaine for three consecutive weeks, once a week.
Primary Outcome Measure Information:
Title
Neck Pain
Description
Severity of pain was assessed using the standard 10 cm VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end
Time Frame
baseline, change from baseline VAS at 4 and 12 weeks after injection
Secondary Outcome Measure Information:
Title
Neck Disability Index (NDI)
Description
Neck Disability Index (NDI) is a self-report 10-item questionnaire used to evaluate the effect of neck pain on daily living activities. Each item is scored from 0 to 5. Higher scores of NDI indicate more disability and pain.
Time Frame
baseline, change from baseline NDI at 4 and 12 after injection
Title
Pain Scor (PS)
Description
Pain Scor (PS) measures the severity of pain felt at the trigger point by placing the thumb to the skin covering the muscle containing the trigger point in a perpendicular fashion and exerting pressure until there was whitening of the nail bed.
Time Frame
baseline, change from baseline PS at 4 and 12 weeks after injection
Title
Range of Motion (ROM) of the neck
Description
Passive ROM measurements of the neck lateral flexion movements were recorded by a universal goniometer.
Time Frame
baseline, change from baseline ROM at 4 and 12 weeks after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with myofascial pain syndrome according to the criteria defined by Simons et al. aged between18-65 having typical myofascial pain symptoms for at least 3 months Exclusion Criteria: presence of cervical radiculopathy, cervical myelopathy, severe dyscal or bony degeneration presence of a history of neck trauma or surgery in the last year presence of trigger point injection for myofascial pain syndrome treatment in the last 3 months presence of cognitive impairment, malignant hypertension, G6PDH (Glucose 6- Phosphate Dehydrogenase) deficiency, Graves' disease, chronic recurrent pancreatitis attack, severe thrombocytopenia (platelet value <50,000 / microliter), cerebrovascular disease in which bleeding is active presence of systemic diseases such as fibromyalgia, inflammatory diseases such as rheumatoid arthritis, polyneuropathy, coagulopathy. presence of pregnancy and breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurdan Korkmaz, MD
Organizational Affiliation
Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, Department of PMR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome

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