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.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Trigger Point Pain, Myofascial, Lumbar Radiculopathy

Intervention / Treatment
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* Procedure: Transforaminal epidural steroid injection(TFESI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Those with active trigger points before TFESI<br>Transforaminal epidural steroid injection | Procedure: Transforaminal epidural steroid injection(TFESI)<br>* 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.<br>|
| Active Comparator: Those who do not have an active trigger point before TFESI<br>Transforaminal epidural steroid injection | Procedure: Transforaminal epidural steroid injection(TFESI)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form-12 | SF-12 is a scale that evaluates the patient's quality of life | 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 | 3 weeks, 3 and 6 months | 
| Doulour Neuropathic 4 (DN4) | DN4 is a scale that evaluates the patient's neuropathic symptoms with 4 questions. | 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 | 3 weeks, 3 and 6 months | 
| Jenkins Sleep Scale | The Jenkins Sleep Scale is a 4-item scale that evaluates sleep. | 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. | 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. | 3 weeks, 3 and 6 months | 
| Number of trigger points | Number of trigger points in muscles innervated by L5 and S1 roots | 3 weeks, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trigger point, Myofascial, Lumbar radiculopathy, Transforaminal epidural steroid injection