AzTrials
AzTrials

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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
What is being tested?
Transforaminal epidural steroid injection(TFESI)
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.

Savaş Şencan contact

+905370665713

savasdr44@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Marmara University

    Istanbul, 34899

    Savaş Şencan, +905370665713, savasdr44@gmail.com

    Osman Albayrak, +905388128889, droalbayrak@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

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 groups in NCT05535010
Study groupRoleWhat they receive
Those with active trigger points before TFESIExperimentalTransforaminal epidural steroid injection
Receives: Procedure: Transforaminal epidural steroid injection(TFESI)
Those who do not have an active trigger point before TFESIActive comparatorTransforaminal 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.

  1. 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)
  1. Short Form-12

    SF-12 is a scale that evaluates the patient's quality of life

    Measured: 3 weeks, 3 and 6 months

  2. 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

  3. 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

  4. 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

  5. Jenkins Sleep Scale

    The Jenkins Sleep Scale is a 4-item scale that evaluates sleep.

    Measured: 3 weeks, 3 and 6 months

  6. 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

  7. 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

  8. 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.

  1. First posted10 Sep 2022
  2. Study start2 May 2022
  3. Primary completion2 Apr 2023 (estimated)
  4. Study completion2 Apr 2023 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in