Trigger Point Pain, MyofascialNCT05535010
The Effect of the Presence of Active Trigger Points in the Muscles Innervated by the Affected Nerve Roots on the Treatment Results of Transforaminal Epidural Steroid Injection in Patients With Lumbar Radiculopathy.
A study testing Transforaminal epidural steroid injection(TFESI) in people with Trigger Point Pain, Myofascial and Lumbar Radiculopathy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The association between lumbosacral radiculopathy and the ipsilateral gluteal trigger point has been demonstrated in 74% of previous studies in patients with chronic low back pain. It has also been found to be associated with lumbosacral radiculopathy, central sensitization and myofascial pain in previous studies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trigger Point Pain, Myofascial, Lumbar Radiculopathy
- What is being tested?
- Transforaminal epidural steroid injection(TFESI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2022to 2 Apr 2023
- 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
- Having low back pain for at least 3 months due to lumbosacral radiculopathy
- Root compression due to paracentral disc herniation at L4-L5 or L5-S1 levels in accordance with the patient's complaint and clinical findings in lumbar MRI imaging
- Being unresponsive to conservative treatment
- Volunteering to participate in the study and signing a consent form
Who cannot join
- History of surgery on the lumbar region/interventional procedure in the last 6 months
- Presence of additional musculoskeletal disease (such as lateral epicondylitis, tendinitis)
- Disease that may change the anatomical or physiological structure of the relevant regions (such as rheumatoid arthritis, osteoporosis)
- Presence of coagulopathy
- Presence of lumbar spinal stenosis
- Having a diagnosis of fibromyalgia
Show all 9Show fewer
- Being pregnant or breastfeeding
- History of allergy to the injectables to be administered
- Having a diagnosis of mental, psychiatric or neurological disease that may complicate the application of the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University
Istanbul, 34899
Savaş Şencan, +905370665713, savasdr44@gmail.com
Osman Albayrak, +905388128889, droalbayrak@gmail.com
About this study
The association between lumbosacral radiculopathy and the ipsilateral gluteal trigger point has been demonstrated in 74% of previous studies in patients with chronic low back pain. It has also been found to be associated with lumbosacral radiculopathy, central sensitization and myofascial pain in previous studies.
From these data, it can be hypothesized that the presence of a myofascial trigger point in the relevant muscle segment may alter the efficacy of the transforaminal epidural steroid injection (TFESI) procedure used in the treatment of lumbosacral radiculopathy. We could not find any study on this subject in the literature. Although the most accurate level for the TFESI procedure is determined according to the patient's examination and imaging findings, patients may not benefit from the procedure sufficiently due to the trigger points on the same side as the radicular pain before the procedure. Another hypothesis is that active trigger points will transform into latent or normal tissue after the TFESI procedure and patients will benefit significantly. This assumption will provide insight into the possible underlying mechanism in some patients who do not benefit from the TFESI procedure. If the active trigger points become latent or there is a significant change in the pressure pain threshold after the TFESI procedure, the formation mechanism of the trigger points will be understood.
TFESI is one of the procedures routinely applied to patients diagnosed with lumbosacral radiculopathy in investigator's clinic. Among the patients who are planned to undergo TFESI procedure, those who are suitable for our study will be selected. Data such as demographic characteristics, height, weight, which leg the pain is reflected in, additional diseases, medications, the stage of the disc herniation, pressure on which nerve root, presence and number of active trigger points, muscles will be recorded before the procedure. Numerical Rating Scale (NRS), Short Form-12, Central Sensitivity Inventory (CSI), Doulour Neuropathic 4 (DN4), 6-point Likert Scale, Jenkins Sleep Scale, Istanbul Low Back Pain Disability Index, Pressure Pain Threshold (active trigger points will be evaluated with an algometer) will be applied to the patients before the procedure. The patients will be evaluated for the presence of active trigger points before the procedure and the patients will be divided into 2 groups as those with active trigger points and those without. The same procedure will be applied to both groups as planned before inclusion of the patients in the study, in the same way as the patients ineligible for the study. Patients will be re-evaluated with the scales and methods mentioned above at the 3rd week, 3rd and 6th months after the first procedure. TFESI procedure will be performed again in the 3rd week and 3rd month for the patients whose NRS values decrease less than 50 percent after the previous procedure.
- Being tested
- Transforaminal epidural steroid injection(TFESI)
- Keywords
- Trigger point, Myofascial, Lumbar radiculopathy, Transforaminal epidural steroid injection
- Medical subject headings
- Myofascial Pain Syndromes, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal epidural steroid injection(TFESI)Procedure or surgery
TFESI procedure will be applied again in the 3rd week and 3rd month for the patients whose NRS score decreased by less than 50 percent after the first procedure.
| Study group | Role | What they receive |
|---|---|---|
| Those with active trigger points before TFESI | Experimental | Transforaminal epidural steroid injection Receives: Procedure: Transforaminal epidural steroid injection(TFESI) |
| Those who do not have an active trigger point before TFESI | Active comparator | Transforaminal epidural steroid injection Receives: Procedure: Transforaminal epidural steroid injection(TFESI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
NRS is a scale in which the patient gives points between "0" and "10" for the low back and leg pain felt by the patient, "0" = No pain, "10" = The most severe, unbearable pain
Measured: 3 months
Secondary outcomes (8)
Short Form-12
SF-12 is a scale that evaluates the patient's quality of life
Measured: 3 weeks, 3 and 6 months
Central Sensitization Inventory (CSI)
The central sensitization scale is a two-part scale that evaluates the patient's neuropathic complaints and records the associated diagnosis, if any
Measured: 3 weeks, 3 and 6 months
Doulour Neuropathic 4 (DN4)
DN4 is a scale that evaluates the patient's neuropathic symptoms with 4 questions.
Measured: 3 weeks, 3 and 6 months
6-point Likert Scale
A 6-point Likert scale is based on patient expression ''1 ''= I am much worse, ''2'' = I am slightly worse, ''3''= I am the same, ''4''= I am slightly better, '' 5''= I am much better, ''6''= I am completely better
Measured: 3 weeks, 3 and 6 months
Jenkins Sleep Scale
The Jenkins Sleep Scale is a 4-item scale that evaluates sleep.
Measured: 3 weeks, 3 and 6 months
Pressure Pain Threshold
Pressure pain threshold is a value measured with an algometer, applied to the skin from an area of 1 cm2, and recording the pressure value at which the person feels pain with increasing pressure.
Measured: 3 weeks, 3 and 6 months
Istanbul Low Back Pain Disability Index
Istanbul Low Back Pain Disability Index, on the other hand, is a scale that evaluates the effect of low back pain on the daily life of a person with 18 questions.
Measured: 3 weeks, 3 and 6 months
Number of trigger points
Number of trigger points in muscles innervated by L5 and S1 roots
Measured: 3 weeks, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start2 May 2022
- Primary completion2 Apr 2023 (estimated)
- Study completion2 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger Point Pain, MyofascialStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535010
- Sponsor's protocol ID
- 04.03.2022.473
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Presence of Active Trigger Points in the Muscles Innervated by the Affected Nerve Roots on the Treatment Results of Transforaminal Epidural Steroid Injection in Patients With Lumbar Radiculopathy.
- ClinicalTrials.gov ID
- NCT05535010
- Acronym / sponsor ID
- 04.03.2022.473
- Keywords
- Trigger point, Myofascial, Lumbar radiculopathy, Transforaminal epidural steroid injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 2 Apr 2023 (estimated)
- Study completion
- 2 Apr 2023 (estimated)
- First posted
- 10 Sep 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.
The association between lumbosacral radiculopathy and the ipsilateral gluteal trigger point has been demonstrated in 74% of previous studies in patients with chronic low back pain. It has also been found to be associated with lumbosacral radiculopathy, central sensitization and myofascial pain in previous studies.
From these data, it can be hypothesized that the presence of a myofascial trigger point in the relevant muscle segment may alter the efficacy of the transforaminal epidural steroid injection (TFESI) procedure used in the treatment of lumbosacral radiculopathy. We could not find any study on this subject in the literature. Although the most accurate level for the TFESI procedure is determined according to the patient's examination and imaging findings, patients may not benefit from the procedure sufficiently due to the trigger points on the same side as the radicular pain before the procedure. Another hypothesis is that active trigger points will transform into latent or normal tissue after the TFESI procedure and patients will benefit significantly. This assumption will provide insight into the possible underlying mechanism in some patients who do not benefit from the TFESI procedure. If the active trigger points become latent or there is a significant change in the pressure pain threshold after the TFESI procedure, the formation mechanism of the trigger points will be understood.
TFESI is one of the procedures routinely applied to patients diagnosed with lumbosacral radiculopathy in investigator's clinic. Among the patients who are planned to undergo TFESI procedure, those who are suitable for our study will be selected. Data such as demographic characteristics, height, weight, which leg the pain is reflected in, additional diseases, medications, the stage of the disc herniation, pressure on which nerve root, presence and number of active trigger points, muscles will be recorded before the procedure. Numerical Rating Scale (NRS), Short Form-12, Central Sensitivity Inventory (CSI), Doulour Neuropathic 4 (DN4), 6-point Likert Scale, Jenkins Sleep Scale, Istanbul Low Back Pain Disability Index, Pressure Pain Threshold (active trigger points will be evaluated with an algometer) will be applied to the patients before the procedure. The patients will be evaluated for the presence of active trigger points before the procedure and the patients will be divided into 2 groups as those with active trigger points and those without. The same procedure will be applied to both groups as planned before inclusion of the patients in the study, in the same way as the patients ineligible for the study. Patients will be re-evaluated with the scales and methods mentioned above at the 3rd week, 3rd and 6th months after the first procedure. TFESI procedure will be performed again in the 3rd week and 3rd month for the patients whose NRS values decrease less than 50 percent after the previous procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Those with active trigger points before TFESI | Experimental | Procedure: Transforaminal epidural steroid injection(TFESI)Transforaminal epidural steroid injection |
| Those who do not have an active trigger point before TFESI | Active comparator | Procedure: Transforaminal epidural steroid injection(TFESI)Transforaminal epidural steroid injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having low back pain for at least 3 months due to lumbosacral radiculopathy
- Root compression due to paracentral disc herniation at L4-L5 or L5-S1 levels in accordance with the patient's complaint and clinical findings in lumbar MRI imaging
- Being unresponsive to conservative treatment
- Volunteering to participate in the study and signing a consent form
Key exclusion criteria (9 listed)
- History of surgery on the lumbar region/interventional procedure in the last 6 months
- Presence of additional musculoskeletal disease (such as lateral epicondylitis, tendinitis)
- Disease that may change the anatomical or physiological structure of the relevant regions (such as rheumatoid arthritis, osteoporosis)
- Presence of coagulopathy
- Presence of lumbar spinal stenosis
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 |
|---|---|---|
| Transforaminal epidural steroid injection(TFESI)TFESI procedure will be applied again in the 3rd week and 3rd month for the patients whose NRS score decreased by less than 50 percent after the first procedure. | Procedure or surgery | Those who do not have an active trigger point before TFESI, Those with active trigger points before TFESI |
Primary outcome
Numeric Rating Scale
Time frame: 3 months
NRS is a scale in which the patient gives points between "0" and "10" for the low back and leg pain felt by the patient, "0" = No pain, "10" = The most severe, unbearable pain
8 secondary outcomes
Short Form-12
Time frame: 3 weeks, 3 and 6 months
Central Sensitization Inventory (CSI)
Time frame: 3 weeks, 3 and 6 months
Doulour Neuropathic 4 (DN4)
Time frame: 3 weeks, 3 and 6 months
6-point Likert Scale
Time frame: 3 weeks, 3 and 6 months
Jenkins Sleep Scale
Time frame: 3 weeks, 3 and 6 months
Pressure Pain Threshold
Time frame: 3 weeks, 3 and 6 months
Istanbul Low Back Pain Disability Index
Time frame: 3 weeks, 3 and 6 months
Number of trigger points
Time frame: 3 weeks, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transforaminal epidural steroid injection(TFESI) in people with Trigger Point Pain, Myofascial and Lumbar Radiculopathy, run by Marmara University 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 4 inclusion and 9 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 6 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Savaş Şencan (+905370665713, savasdr44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (time frame: 3 months). 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 6 Jan 2023.