Myofascial Pain SyndromeNCT05318560
Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome
A study testing Lidocaine 2% Injectable Solution, Ozone and stretching exercise in people with Myofascial Pain Syndrome and Ozone, run by Pamukkale University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Myofascial Pain Syndrome, Ozone
- What is being tested?
- Lidocaine 2% Injectable Solution, Ozone and stretching exercise
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2022to 10 Dec 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- With at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of MPS
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Hakan Alkan, Prof. contact
About this study
Official title: Comparison of the Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome
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.
Read the 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.
- Conditions
- Myofascial Pain Syndrome, Ozone
- Being tested
- Lidocaine 2% Injectable Solution, Ozone, stretching exercise
- Keywords
- Ozone, Pain
- Medical subject headings
- Myofascial Pain Syndromes, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% Injectable SolutionDrug
Also called jetokain simplex
for MPS
OzoneDrug
for MPS
stretching exerciseOther
for MPS
| Study group | Role | What they receive |
|---|---|---|
| Local anesthetic injection | Active comparator | 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. Receives: Drug: Lidocaine 2% Injectable Solution; Other: stretching exercise |
| Ozone injection | Active comparator | 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. Receives: Drug: Ozone; Other: stretching exercise |
| Stretching exercise | Active comparator | 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. Receives: Other: stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline VAS at the 1st week after the treatment.
Secondary outcomes (2)
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.
Measured: Change from baseline VAS at the 1st week after the treatment.
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.
Measured: Change from baseline VAS at the 1st week after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start30 Jun 2022 (estimated)
- Primary completion10 Sep 2022 (estimated)
- Study completion10 Dec 2022 (estimated)
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.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Alkan, Pamukkale University
- Investigators
- Hakan Alkan, Prof., Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318560
- Sponsor's protocol ID
- PamukkaleU-Simsek-003
- Status last verified
- Jun 2022
- First submitted
- 30 Mar 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT05318560
- Acronym / sponsor ID
- PamukkaleU-Simsek-003
- Conditions
- Myofascial Pain Syndrome, Ozone
- Keywords
- Ozone, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 10 Sep 2022 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 8 Apr 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Local anesthetic injection | Active comparator | Drug: Lidocaine 2% Injectable Solution, Other: stretching exercisePatients 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 | Active comparator | Drug: Ozone, Other: stretching exerciseOzone 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. |
| Stretching exercise | Active comparator | Other: stretching exercisePatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- With at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of MPS
Key exclusion criteria (6 listed)
- 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,
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 |
|---|---|---|
| Lidocaine 2% Injectable SolutionAlso: jetokain simplexfor MPS | Drug | Local anesthetic injection |
| Ozonefor MPS | Drug | Ozone injection |
| stretching exercisefor MPS | Other | Local anesthetic injection, Ozone injection, Stretching exercise |
Primary outcome
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.
2 secondary outcomes
Neck Disability Index (NDI)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
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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.
Hakan Alkan, Prof. contact
Hakan Alkan, Prof. study director
Pamukkale University
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 2% Injectable Solution, Ozone and stretching exercise in people with Myofascial Pain Syndrome and Ozone, run by Pamukkale University.
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 1 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: status not confirmed, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayse Simsek, m.d. (+905319698492, draysesimsek2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: Change from baseline VAS at the 1st week after the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2022.