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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.

Primary Purpose

Trigger Point Pain, Myofascial, Lumbar Radiculopathy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transforaminal epidural steroid injection(TFESI)
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Point Pain, Myofascial focused on measuring Trigger point, Myofascial, Lumbar radiculopathy, Transforaminal epidural steroid injection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Marmara UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Those with active trigger points before TFESI

Those who do not have an active trigger point before TFESI

Arm Description

Transforaminal epidural steroid injection

Transforaminal epidural steroid injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 1, 2022
Last Updated
January 5, 2023
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05535010
Brief 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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
April 2, 2023 (Anticipated)
Study Completion Date
April 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Point Pain, Myofascial, Lumbar Radiculopathy
Keywords
Trigger point, Myofascial, Lumbar radiculopathy, Transforaminal epidural steroid injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Those with active trigger points before TFESI
Arm Type
Experimental
Arm Description
Transforaminal epidural steroid injection
Arm Title
Those who do not have an active trigger point before TFESI
Arm Type
Active Comparator
Arm Description
Transforaminal epidural steroid injection
Intervention Type
Procedure
Intervention Name(s)
Transforaminal epidural steroid injection(TFESI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Rating Scale
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Short Form-12
Description
SF-12 is a scale that evaluates the patient's quality of life
Time Frame
3 weeks, 3 and 6 months
Title
Central Sensitization Inventory (CSI)
Description
The central sensitization scale is a two-part scale that evaluates the patient's neuropathic complaints and records the associated diagnosis, if any
Time Frame
3 weeks, 3 and 6 months
Title
Doulour Neuropathic 4 (DN4)
Description
DN4 is a scale that evaluates the patient's neuropathic symptoms with 4 questions.
Time Frame
3 weeks, 3 and 6 months
Title
6-point Likert Scale
Description
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
Time Frame
3 weeks, 3 and 6 months
Title
Jenkins Sleep Scale
Description
The Jenkins Sleep Scale is a 4-item scale that evaluates sleep.
Time Frame
3 weeks, 3 and 6 months
Title
Pressure Pain Threshold
Description
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.
Time Frame
3 weeks, 3 and 6 months
Title
Istanbul Low Back Pain Disability Index
Description
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.
Time Frame
3 weeks, 3 and 6 months
Title
Number of trigger points
Description
Number of trigger points in muscles innervated by L5 and S1 roots
Time Frame
3 weeks, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Savaş Şencan
Phone
+905370665713
Email
savasdr44@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Osman Albayrak
Phone
+905388128889
Email
droalbayrak@gmail.com
Facility Information:
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Savaş Şencan
Phone
+905370665713
Email
savasdr44@gmail.com
First Name & Middle Initial & Last Name & Degree
Osman Albayrak
Phone
+905388128889
Email
droalbayrak@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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.

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