Myofascial Pain SyndromesNCT06768281
Effect of Lidocaine and Ozone in Injection for Myofascial Pain
A study testing Headache Impact Test-6 (HIT-6), Pittsburgh Sleep Quality Index (PSQI) and Visual Analogue Score (VAS) in people with Myofascial Pain Syndromes, run by Yağmur Malkoc at 1 site in Turkey (Türkiye).
Trial summary
Myofascial pain syndrome (MPS) is a chronic soft tissue rheumatism characterized by tense, painful muscle bands, known as trigger points, located within the muscle or fascia. These trigger points typically lead to pain during movement, limiting muscle extension and reducing mobility. Read more about this study
- Who is it for?
- Ages 17 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndromes
- What is being tested?
- Headache Impact Test-6 (HIT-6), Pittsburgh Sleep Quality Index (PSQI) and Visual Analogue Score (VAS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2021to 27 Sep 2024
- 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 17 to 42 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- No temporomandibular joint treatment within the last year.
- Presence of palpable trigger points in the unilateral/bilateral masseter muscle.
- Classified as ASA 1 or ASA 2.
- Chronic pain in the masseter muscle for at least the past three months.
- Presence of at least two palpable trigger points in the unilateral or bilateral masseter muscle, with a pain score of ≥ 3 on the Visual Analog Scale (VAS) upon palpation
Who cannot join
- History of allergy to any anesthetic agent.
- Use of anticoagulant medications.
- Use of analgesics, muscle relaxants, or antidepressants within the last month.
- Diagnosed with specific conditions such as migraine, neuromuscular junction disorders, fibromyalgia, depression, or schizophrenia.
- History of trauma, tumor, or surgery in the head-neck region.
- Presence of skin infection in the relevant area.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Fatih, 34083
About this study
Official title: Comparison of the Efficacy of Lidocaine and Ozone in Masticatory Muscle Injections for Patients With Myofascial Pain
Myofascial pain syndrome (MPS) is a chronic soft tissue rheumatism characterized by tense, painful muscle bands, known as trigger points, located within the muscle or fascia. These trigger points typically lead to pain during movement, limiting muscle extension and reducing mobility. While various treatments exist for MPS, the most common approach is injecting local anesthetic agents directly into the trigger points to relieve pain. Recently, systemic and local ozone therapy has also gained popularity as an alternative treatment for MPS. Ozone can be injected directly into muscles in areas such as the back and waist to target pain and inflammation. The aim of this study is to investigate the clinical effectiveness of ozone therapy with lidocaine injection in patients diagnosed with MPS.The aim of this study was to compare 2% non-vasoconstrictor lidocaine and ozone injections in the treatment of patients presenting to the clinic with myofascial pain syndrome and to determine the more therapeutic method.
Read the detailed description
60 patients between the ages of 18-65 diagnosed with MPS were included in the study. The patients were randomly divided into four groups. As the control group, the first group was injected with isotonic saline, the second group was injected with 2% lidocaine without vasoconstrictor, the third group was injected with ozone gas and the fourth group was injected with ozonated isotonic saline. Patients were evaluated with VAS score before treatment, at 1, 2, 4 weeks and 3 months after treatment. In addition, quality of life was evaluated with HIT-6 and Pittsburgh Sleep Quality Index (PSQI) scales before treatment and at the 1st and 3rd months after treatment.
- Conditions
- Myofascial Pain Syndromes
- Being tested
- Headache Impact Test-6 (HIT-6), Pittsburgh Sleep Quality Index (PSQI), Visual Analogue Score (VAS), Masseter muscle injection
- Keywords
- ozone, lidocaine, Myofascial Pain Syndrome
- 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.
Headache Impact Test-6 (HIT-6)Diagnostic test
Patients who had injections were asked to mark their headache severities with a survey includes six questions about their past 4 weeks. The test applied preoperatively, postoperatively 1st and 3rd months.
Pittsburgh Sleep Quality Index (PSQI)Diagnostic test
Patients who had injections were asked to reply some questions about their sleeping habits for past 4 weeks. The test applied preoperatively, postoperatively 1st and 3rd months.
Visual Analogue Score (VAS)Diagnostic test
Patients who had injections are asked to state their pain with a 10 cm visual analogue scale preoperatively and postoperatively 1st,2nd weeks and 1st and 3rd months.
Masseter muscle injectionOther
1 ml of insulin needle with a 27-gauge ½ inch 13 mm needle tip will be injected into up to 4 trigger points in the taut bands that cause the most pain in the masseter muscle. Injections were done at most 3 times. As the control group, the first group was injected with isotonic saline; the second group was injected with 2% lidocaine without vasoconstrictor; the third group with ozone gas; and the fourth group with ozonated isotonic saline.
| Study group | Role | What they receive |
|---|---|---|
| Streaming of patients and administration of substances | Experimental | 60 patients with myofascial pain syndrome who met the inclusion criteria were divided into four groups into isotonic saline, lidocaine, ozone gas and ozonated isotonic saline. Then the injections were done for each group. Receives: Diagnostic Test: Headache Impact Test-6 (HIT-6); Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI); Diagnostic Test: Visual Analogue Score (VAS); Other: Masseter muscle injection |
| Repetition of tests at certain intervals | Experimental | Quality of life was evaluated by administering PSQI and HIT-6 tests at postoperative 1st and 3rd months. Receives: Diagnostic Test: Headache Impact Test-6 (HIT-6); Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI); Diagnostic Test: Visual Analogue Score (VAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. The pain assessment after injections
The primary outcome was the Visual Analog Score (VAS), a simple tool that allows the patient to express pain visually and numerically and is particularly effective in measuring subjective sensations. The patient is asked to choose a number between 0 and 10 indicating the pain level, with 0 indicating the least pain and 10 indicating the most pain.
Measured: Three months
2. Headache evaluation after injections
The second outcome was the Headache Impact Test-6 (HIT-6), which is used to assess headaches. 6 indicates the lowest score, and 13 indicates the highest score.
Measured: Three months
3. Sleep quality evaluation after injections
The third outcome was the Pittsburgh Sleep Quality Index (PSQI), consists of 7 main components and a total of 19 questions. Each component is scored from 0 to 3; the total PSQI score ranges from 0 to 21. High scores indicate a decrease in quality of life while descending scores indicate an increase.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start25 Mar 2021
- Primary completion14 Jan 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromesStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yağmur Malkoc
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Medipol University Hospital
- Responsible party
- Sponsor-investigator, Yağmur Malkoc, Istanbul Medipol University Hospital
- Investigators
- ÇAĞRI DELİLBAŞI, PROF., Study director, Medipol universitesi diş hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768281
- Sponsor's protocol ID
- IstanbulMUH-DF-YM-02
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albagieh H, Aloyouny A, Alshehri N, Alsammahi N, Almutrafi D, Hadlaq E. Efficacy of lidocaine versus mepivacaine in the management of myofascial pain. Saudi Pharm J. 2020 Oct;28(10):1238-1242. doi: 10.1016/j.jsps.2020.08.014. Epub 2020 Aug 28.
PubMed 33132718Yilmaz O, Sivrikaya EC, Taskesen F, Pirpir C, Ciftci S. Comparison of the Efficacy of Botulinum Toxin, Local Anesthesia, and Platelet-Rich Plasma Injections in Patients With Myofascial Trigger Points in the Masseter Muscle. J Oral Maxillofac Surg. 2021 Jan;79(1):88.e1-88.e9. doi: 10.1016/j.joms.2020.09.013. Epub 2020 Sep 14.
PubMed 33045182Kamanli A, Kaya A, Ardicoglu O, Ozgocmen S, Zengin FO, Bayik Y. Comparison of lidocaine injection, botulinum toxin injection, and dry needling to trigger points in myofascial pain syndrome. Rheumatol Int. 2005 Oct;25(8):604-11. doi: 10.1007/s00296-004-0485-6. Epub 2004 Sep 15.
PubMed 15372199
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Lidocaine and Ozone in Masticatory Muscle Injections for Patients With Myofascial Pain
- ClinicalTrials.gov ID
- NCT06768281
- Acronym / sponsor ID
- IstanbulMUH-DF-YM-02
- Conditions
- Myofascial Pain Syndromes
- Keywords
- ozone, lidocaine, Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yağmur MalkocUniversity, hospital or other
- Collaborators
- Istanbul Medipol University Hospital
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 14 Jan 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 10 Jan 2025 (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.
Myofascial pain syndrome (MPS) is a chronic soft tissue rheumatism characterized by tense, painful muscle bands, known as trigger points, located within the muscle or fascia. These trigger points typically lead to pain during movement, limiting muscle extension and reducing mobility. While various treatments exist for MPS, the most common approach is injecting local anesthetic agents directly into the trigger points to relieve pain. Recently, systemic and local ozone therapy has also gained popularity as an alternative treatment for MPS. Ozone can be injected directly into muscles in areas such as the back and waist to target pain and inflammation. The aim of this study is to investigate the clinical effectiveness of ozone therapy with lidocaine injection in patients diagnosed with MPS.The aim of this study was to compare 2% non-vasoconstrictor lidocaine and ozone injections in the treatment of patients presenting to the clinic with myofascial pain syndrome and to determine the more therapeutic method.
Detailed description
60 patients between the ages of 18-65 diagnosed with MPS were included in the study. The patients were randomly divided into four groups. As the control group, the first group was injected with isotonic saline, the second group was injected with 2% lidocaine without vasoconstrictor, the third group was injected with ozone gas and the fourth group was injected with ozonated isotonic saline. Patients were evaluated with VAS score before treatment, at 1, 2, 4 weeks and 3 months after treatment. In addition, quality of life was evaluated with HIT-6 and Pittsburgh Sleep Quality Index (PSQI) scales before treatment and at the 1st and 3rd months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Streaming of patients and administration of substances | Experimental | Diagnostic Test: Headache Impact Test-6 (HIT-6), Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI), Diagnostic Test: Visual Analogue Score (VAS), Other: Masseter muscle injection60 patients with myofascial pain syndrome who met the inclusion criteria were divided into four groups into isotonic saline, lidocaine, ozone gas and ozonated isotonic saline. Then the injections were done for each group. |
| Repetition of tests at certain intervals | Experimental | Diagnostic Test: Headache Impact Test-6 (HIT-6), Diagnostic Test: Pittsburgh Sleep Quality Index (PSQI), Diagnostic Test: Visual Analogue Score (VAS)Quality of life was evaluated by administering PSQI and HIT-6 tests at postoperative 1st and 3rd months. |
Who may qualify
- Ages
- 17 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- No temporomandibular joint treatment within the last year.
- Presence of palpable trigger points in the unilateral/bilateral masseter muscle.
- Classified as ASA 1 or ASA 2.
- Chronic pain in the masseter muscle for at least the past three months.
- Presence of at least two palpable trigger points in the unilateral or bilateral masseter muscle, with a pain score of ≥ 3 on the Visual Analog Scale (VAS) upon palpation
Key exclusion criteria (6 listed)
- History of allergy to any anesthetic agent.
- Use of anticoagulant medications.
- Use of analgesics, muscle relaxants, or antidepressants within the last month.
- Diagnosed with specific conditions such as migraine, neuromuscular junction disorders, fibromyalgia, depression, or schizophrenia.
- History of trauma, tumor, or surgery in the head-neck region.
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 |
|---|---|---|
| Headache Impact Test-6 (HIT-6)Patients who had injections were asked to mark their headache severities with a survey includes six questions about their past 4 weeks. The test applied preoperatively, postoperatively 1st and 3rd months. | Diagnostic test | Repetition of tests at certain intervals, Streaming of patients and administration of substances |
| Pittsburgh Sleep Quality Index (PSQI)Patients who had injections were asked to reply some questions about their sleeping habits for past 4 weeks. The test applied preoperatively, postoperatively 1st and 3rd months. | Diagnostic test | Repetition of tests at certain intervals, Streaming of patients and administration of substances |
| Visual Analogue Score (VAS)Patients who had injections are asked to state their pain with a 10 cm visual analogue scale preoperatively and postoperatively 1st,2nd weeks and 1st and 3rd months. | Diagnostic test | Repetition of tests at certain intervals, Streaming of patients and administration of substances |
| Masseter muscle injection1 ml of insulin needle with a 27-gauge ½ inch 13 mm needle tip will be injected into up to 4 trigger points in the taut bands that cause the most pain in the masseter muscle. Injections were done at most 3 times. As the control group, the first group was injected with isotonic saline; the second group was injected with 2% lidocaine without vasoconstrictor; the third group with ozone gas; and the fourth group with ozonated isotonic saline. | Other | Streaming of patients and administration of substances |
Primary outcome
1. The pain assessment after injections
Time frame: Three months
The primary outcome was the Visual Analog Score (VAS), a simple tool that allows the patient to express pain visually and numerically and is particularly effective in measuring subjective sensations. The patient is asked to choose a number between 0 and 10 indicating the pain level, with 0 indicating the least pain and 10 indicating the most pain.
2. Headache evaluation after injections
Time frame: Three months
The second outcome was the Headache Impact Test-6 (HIT-6), which is used to assess headaches. 6 indicates the lowest score, and 13 indicates the highest score.
3. Sleep quality evaluation after injections
Time frame: Three months
The third outcome was the Pittsburgh Sleep Quality Index (PSQI), consists of 7 main components and a total of 19 questions. Each component is scored from 0 to 3; the total PSQI score ranges from 0 to 21. High scores indicate a decrease in quality of life while descending scores indicate an increase.
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 10 Jan 2025.
- Background: PubMed 33132718Albagieh H, Aloyouny A, Alshehri N, Alsammahi N, Almutrafi D, Hadlaq E. Efficacy of lidocaine versus mepivacaine in the management of myofascial pain. Saudi Pharm J. 2020 Oct;28(10):1238-1242. doi: 10.1016/j.jsps.2020.08.014. Epub 2020 Aug 28.
- Background: PubMed 33045182Yilmaz O, Sivrikaya EC, Taskesen F, Pirpir C, Ciftci S. Comparison of the Efficacy of Botulinum Toxin, Local Anesthesia, and Platelet-Rich Plasma Injections in Patients With Myofascial Trigger Points in the Masseter Muscle. J Oral Maxillofac Surg. 2021 Jan;79(1):88.e1-88.e9. doi: 10.1016/j.joms.2020.09.013. Epub 2020 Sep 14.
- Background: PubMed 15372199Kamanli A, Kaya A, Ardicoglu O, Ozgocmen S, Zengin FO, Bayik Y. Comparison of lidocaine injection, botulinum toxin injection, and dry needling to trigger points in myofascial pain syndrome. Rheumatol Int. 2005 Oct;25(8):604-11. doi: 10.1007/s00296-004-0485-6. Epub 2004 Sep 15.
- Clinical Study ReportLink provided by the sponsor.
- Clinical Study ReportLink provided by the sponsor.
- Clinical Study ReportLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
ÇAĞRI DELİLBAŞI, PROF. study director
Medipol universitesi diş hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Headache Impact Test-6 (HIT-6), Pittsburgh Sleep Quality Index (PSQI) and Visual Analogue Score (VAS) in people with Myofascial Pain Syndromes, run by Yağmur Malkoc at 1 site in Turkey (Türkiye).
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 5 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 10 Jan 2025. 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?
1. The pain assessment after injections (time frame: Three months). The study lists 3 primary outcomes in all. 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 NCT06768281, which also lists 3 linked publications.
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 10 Jan 2025.