Myofascial Pain SyndromeNCT04885881

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

A study testing Ozone therapy and Lidocaine injection group in people with Myofascial Pain Syndrome and Myofascial Trigger Point Pain, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Myofascial Pain Syndrome, Myofascial Trigger Point Pain
What is being tested?: Ozone therapy and Lidocaine injection group
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Apr 2021to 1 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome: A Prospective Randomized Controlled Study

Read the 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.

Conditions: Myofascial Pain Syndrome, Myofascial Trigger Point Pain
Being tested: Ozone therapy, Lidocaine injection group
Keywords: myofascial pain syndrome, trigger point pain, ozone, lidocaine
Medical subject headings: Myofascial Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ozone therapyProcedure or surgery
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.
Lidocaine injection groupProcedure or surgery
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.

Study groups in NCT04885881
Study group	Role	What they receive
Ozone therapy group	Active comparator	Patients with myofascial pain syndrome receiving ozone injection Receives: Procedure: Ozone therapy
Lidocaine injection group	Active comparator	Patients with myofascial pain syndrome receiving lidocaine injection Receives: Procedure: Lidocaine injection group

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: baseline, change from baseline VAS at 4 and 12 weeks after injection

Secondary outcomes (3)

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.
Measured: baseline, change from baseline NDI at 4 and 12 after injection
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.
Measured: baseline, change from baseline PS at 4 and 12 weeks after injection
Range of Motion (ROM) of the neck
Passive ROM measurements of the neck lateral flexion movements were recorded by a universal goniometer.
Measured: baseline, change from baseline ROM at 4 and 12 weeks after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 20211 Dec 2021

First posted13 May 2021
Study start15 Apr 2021
Primary completion1 Dec 2021
Study completion1 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04885881
Sponsor's protocol ID: 14
Status last verified: Jan 2022
First submitted: 8 May 2021
Last updated: 18 Jan 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myofascial Pain Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome: A Prospective Randomized Controlled Study
ClinicalTrials.gov ID: NCT04885881
Acronym / sponsor ID: 14
Conditions: Myofascial Pain Syndrome, Myofascial Trigger Point Pain
Keywords: myofascial pain syndrome, trigger point pain, ozone, lidocaine
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
Study start: 15 Apr 2021 (actual)
Primary completion: 1 Dec 2021 (actual)
Study completion: 1 Dec 2021 (actual)
First posted: 13 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ozone therapy group	Active comparator	Procedure: Ozone therapyPatients with myofascial pain syndrome receiving ozone injection
Lidocaine injection group	Active comparator	Procedure: Lidocaine injection groupPatients with myofascial pain syndrome receiving lidocaine injection

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ozone therapyPatients 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.	Procedure or surgery	Ozone therapy group
Lidocaine injection groupPatients 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.	Procedure or surgery	Lidocaine injection group

Primary outcome

Neck Pain
Time frame: baseline, change from baseline VAS at 4 and 12 weeks after injection
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

3 secondary outcomes

Neck Disability Index (NDI)
Time frame: baseline, change from baseline NDI at 4 and 12 after injection
Pain Scor (PS)
Time frame: baseline, change from baseline PS at 4 and 12 weeks after injection
Range of Motion (ROM) of the neck
Time frame: baseline, change from baseline ROM at 4 and 12 weeks after injection

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.

Related trials for Myofascial Pain Syndrome

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nurdan Korkmaz, MD principal investigator

Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, Department of PMR

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck Pain (time frame: baseline, change from baseline VAS at 4 and 12 weeks after injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04885881.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.