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Herniated DiscNCT05601791

Efficacy of PLDD Versus ESI in the Treatment of Lumbar Radicular Pain

A study testing Epidural Steroid Injection and Percutaneous Laser Disc Decompression in people with Herniated Disc and Low Back Pain, run by Osijek University Hospital at 1 site in Croatia.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The most common cause of lumbar radicular pain is intervertebral disc herniation with or without pressure on the nerve root, which leads to inflammation and pain. Just as the mechanical component is important, so is the inflammatory component in the etiology of lumbar radicular pain. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Herniated Disc, Low Back Pain
What is being tested?
Epidural Steroid Injection and Percutaneous Laser Disc Decompression
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteCroatia
Study dates
30 Nov 2021to 30 Jul 2024
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

  • Age between 18 and 60
  • Signing informed consent
  • Unilateral lumbar radicular pain
  • Subjects who do not responds to conservative treatment
  • Disc herniation at one level
  • MR verified disc herniation
  • Pain intensity measured by VAS scale, from 0 - 10, >5

Who cannot join

  • Subjects younger than 18 and older than 65 years
  • Refusal of the subjects to participate in the research
  • Central stenosis of the lumbar canal
  • Lumbar radicular pain caused by causes other than intervertebral disc herniation
  • Pregnancy
  • Allergy to steroids, local anesthetics, fentanyl, midazolam and contrast medium
Show all 12Show fewer
  • Positive history of prolonged bleeding
  • Local or systemic infection
  • Previous lumbar spine surgery7
  • Opioid abuse
  • Proven inflammatory rheumatic disease and inflammatory bowel disease in the active phase
  • Other acute infections

Trial locations and contacts

1 site in 1 country.

Dino Budrovac, MD contact

+385995162489

dino.budrovac@gmail.com

Ivan Radoš, Prof.MD.PhD contact

+385917974306

irados11@gmail.com

Croatia1 site, 1 recruiting

  • UH Osijek

    Osijek, 31000

    Ivan Radoš, Prof.MD,PhD, +385917974306, irados11@gmail.com

    Dino Budrovac, MD

    Recruiting

Other trials in Croatia

About this study

Official title: Efficacy of Percutaneous Laser Disc Decompression Versus Epidural Steroid and Local Anesthetic Injection by Transforaminal Approach in the Treatment of Lumbar Radicular Pain

The most common cause of lumbar radicular pain is intervertebral disc herniation with or without pressure on the nerve root, which leads to inflammation and pain. Just as the mechanical component is important, so is the inflammatory component in the etiology of lumbar radicular pain. Numerous pro-inflammatory and anti-inflammatory proteins were found in serum, cerebrospinal fluid and disc biopsies from patients with lumbar radicular pain. Interleukin(IL)-1β, IL-6, IL-8, and tumor necrosis factor TNF-α are the most frequently investigated (8, 9).

Elevated levels of IL-6 and TNF-α were found in patients with lumbar pain caused by intervertebral disc herniation.

Read more

In order to avoid systemic and unwanted effects of analgesics, undergoing anesthesia and long-term and extensive operations, minimally invasive procedures are increasingly used in the treatment of lumbar radicular pain. Epidural administration of steroids and local anesthetic through a transforaminal approach (ESI TF) and percutaneous laser disc decompression (PLDD) are some of these methods.

Lumbar radicular pain occurs due to inflammation and/or disc-radicular contact. Corticosteroids interrupt the inflammatory process, the transmission of pain signals via nociceptive C fibers and reduce capillary permeability. Along with the corticosteroid, a local anesthetic is also applied, which leads to immediate analgesia by blocking the conduction of painful impulses by blocking sodium channels. Percutaneous laser disc decompression (PLDD) is a minimally invasive method of treating lumbar radicular pain performed under local anesthesia under fluoroscopic control. The laser energy leads to the heating of the tissue of the nucleus pulposus, which leads to the evaporation of a small volume of water inside the disc. Viewing the disc as a closed hydraulic system, a small decrease in the water content within the disc leads to a disproportionate decrease in intradiscal pressure, which results in retraction of the herniated disc. Thermal energy leads to protein denaturation, which causes structural changes and thus prevents further retention of water in the disc, and a stable scar is created at the point of laser action. On the basis of current knowledge, an attempt is made to establish a link between inflammatory parameters as predictive and prognostic biomarkers in the treatment of patients with lumbar radicular pain caused by intervertebral disc herniation.

Read the detailed description

The hypothesis is that:

  • there will be no difference in effectiveness in reducing the intensity of pain, improving the quality of life, reducing the degree of disability, reducing neuropathic pain, reducing anxiety and depression, and improving the quality of sleep in the treatment of lumbar radicular pain caused by disc herniation without discoradicular contact, but PLDD will be more effective in patients where there is discorradicular contact
  • PLDD will lead to a greater reduction in serum levels of inflammatory markers in patients with nerve compression by intervertebral disc herniation
  • ESI TF will lead to a greater reduced serum level of inflammatory markers where there is no nerve compression by intervertebral disc herniation
  • The group of patients in whom PLDD was performed will have a significantly greater retraction of the disc herniation compared to ESI TF
Being tested
Epidural Steroid Injection, Percutaneous Laser Disc Decompression
Keywords
herniated disc, epidural injection, laser, low back pain, radiculopathy
Medical subject headings
Intervertebral Disc Displacement, Low Back Pain, Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epidural Steroid InjectionProcedure or surgery

    Epidural Steroid Injection transforaminal approach Drug: midazolam, fentanyl, lidocaine, levobupivacaine, methilprednisoloneacetat

  • Percutaneous Laser Disc DecompressionProcedure or surgery

    Percutaneous Laser Disc Decompression Drug: midazolam, fentanyl, lidocaine

Study groups in NCT05601791
Study groupRoleWhat they receive
Discoradicular contact+ESI TFActive comparatorPatients with discorradicular contact who underwent ESI TF
Receives: Procedure: Epidural Steroid Injection
Discoradicular contact+PLDDActive comparatorPatients with discorradicular contact who underwent PLDD
Receives: Procedure: Percutaneous Laser Disc Decompression
Without discoradicular contact+ESI TFActive comparatorPatients without discorradicular contact who underwent ESI TF
Receives: Procedure: Epidural Steroid Injection
Without discoradicular contact+PLDDActive comparatorPatients without discorradicular contact who underwent PLDD
Receives: Procedure: Percutaneous Laser Disc Decompression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the effectiveness in reducing pain intensity with ESI TF and PLDD in patients with lumbar radicular pain caused by intervertebral disc herniation

    Compare the effectiveness in reducing pain intensity with epidural administration of steroids and local anesthetic through a transforaminal approach (ESI TF) and percutaneous laser disc decompression (PLDD) in patients with lumbar radicular pain caused by intervertebral disc herniation, measured by the VAS scale (0-10). The severity of pain was assessed using the visual-analog scale of pain (VAS). The scale consists of a solid line that is 0 to 10 numbered at both its beginning and conclusion. The number 0, which denotes the lack of pain, is located on the far left, while the number 10, which denotes unbearable pain, is located on the far right.

    Measured: Six months

  2. Investigate the difference imeasured with a visual analogue scale between ESI TF and PLDD in herniated intervertebral disc with and without discoradicular contact

    Investigate the difference measured with a visual analogue scale between ESI TF and PLDD in herniated intervertebral disc with and without discoradicular contact. The severity of pain was assessed using the visual-analog scale of pain (VAS). The scale consists of a solid line that is 0 to 10 numbered at both its beginning and conclusion. The number 0, which denotes the lack of pain, is located on the far left, while the number 10, which denotes unbearable pain, is located on the far right.

    Measured: Six months

Secondary outcomes (7)

  1. Investigate the influence of ESI TF and PLDD on the serum level of interleukin-6 (IL-6)

    Investigate the influence of ESI TF and PLDD on the serum level of interleukin-6 (IL-6)

    Measured: Six months

  2. Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on quality of life

    Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on quality of life measured by SF-36 (Short form health survey-36). The Health Status Questionnaire SF-36 was used to examine health status and health-related quality of life. The questionnaire is intended for self-assessment of mental and physical health and social functioning. The SF-36 is a short health status questionnaire consisting of 36 questions. The score is expressed as a standardized value ranging from 0 to 100 for each dimension. Low scores reflect reduced and limited functionality, i.e. loss of function, existence of pain and poor health assessment. High scores reflect the assessment of health as good, without pain and without functional limitations.

    Measured: Six months

  3. Investigate the influence of PLDD and ESI TF on the retraction of disc herniation

    Investigate the influence of PLDD and ESI TF on the retraction of disc herniation which will be measured by MR control after 6 months

    Measured: Six months

  4. Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on degree of disability

    Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on degree of disability measured by Oswestry Disability Questionnaire Index (ODI). The degree of disability for carrying out everyday activities as a result of low back pain will be evaluated using the Oswestry Disability Index (ODI) questionnaire. The domains of the questionnaire cover aspects of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual function, social life, and traveling, each one containing six statements about section-related activities. The responses are scored on a 0-5 scale. Total score is expressed as the percentage of the maximum score with lower scores indicating lower levels of disability and vice versa.

    Measured: Six months

  5. Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on neuropathic pain

    Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on neuropathic pain measured by Pain Detect. The Pain Detect questionnaire is a standardized questionnaire for screening the probability of the existence of a neuropathic pain component in patients with chronic pain. It consists of three parts in sequence from the assessment of the intensity of the pain through the pictorial presentation of the nature of the pain and the main area of the pain to the final questions about the severity of the sensory symptoms which are classified into five groups according to the intensity, from never to very severe.

    Measured: Six months

  6. Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on degree of anxiety and depression

    Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on degree of anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS). The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.

    Measured: Six months

  7. Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on quality of sleep

    Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI), consisting of 19 items, each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2022
  2. Study start30 Nov 2021
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Jul 2024 (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
Randomised
Intervention model
Parallel groups
Model description
The research is designed as a randomized controlled trial, and will be conducted at the Clinic for Anesthesiology, Reanimatology and Intensive Medicine in the Department of Pain Management of the Osijek Clinical Hospital Center after obtaining the approval of the Ethics Committee. All patients will receive a written informed consent in which the procedure to be performed will be described, and the procedure will also be explained to them orally. After signing the informed consent, the patients will be divided into 2 groups using a random number generator, depending on whether there is discorradicular contact or not, and then according to the treatment method (ESI TF or PLDD). All subjects will be selected at the Institute for Pain Management of KBC Osijek.
Masking
None (open label)
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05601791
Sponsor's protocol ID
2158-61-07-20-05
Status last verified
Oct 2022
First submitted
12 Oct 2022
Last updated
3 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.

    PubMed 24665116

  • Khan AN, Jacobsen HE, Khan J, Filippi CG, Levine M, Lehman RA Jr, Riew KD, Lenke LG, Chahine NO. Inflammatory biomarkers of low back pain and disc degeneration: a review. Ann N Y Acad Sci. 2017 Dec;1410(1):68-84. doi: 10.1111/nyas.13551.

    PubMed 29265416

  • Porchet F, Wietlisbach V, Burnand B, Daeppen K, Villemure JG, Vader JP. Relationship between severity of lumbar disc disease and disability scores in sciatica patients. Neurosurgery. 2002 Jun;50(6):1253-9; discussion 1259-60. doi: 10.1097/00006123-200206000-00014.

    PubMed 12015843

  • el Barzouhi A, Vleggeert-Lankamp CL, Lycklama a Nijeholt GJ, Van der Kallen BF, van den Hout WB, Jacobs WC, Koes BW, Peul WC; Leiden-The Hague Spine Intervention Prognostic Study Group. Magnetic resonance imaging in follow-up assessment of sciatica. N Engl J Med. 2013 Mar 14;368(11):999-1007. doi: 10.1056/NEJMoa1209250.

    PubMed 23484826

  • Wuertz K, Haglund L. Inflammatory mediators in intervertebral disk degeneration and discogenic pain. Global Spine J. 2013 Jun;3(3):175-84. doi: 10.1055/s-0033-1347299. Epub 2013 May 21.

    PubMed 24436868

  • Jungen MJ, Ter Meulen BC, van Osch T, Weinstein HC, Ostelo RWJG. Inflammatory biomarkers in patients with sciatica: a systematic review. BMC Musculoskelet Disord. 2019 Apr 9;20(1):156. doi: 10.1186/s12891-019-2541-0.

    PubMed 30967132

  • Kraychete DC, Sakata RK, Issy AM, Bacellar O, Santos-Jesus R, Carvalho EM. Serum cytokine levels in patients with chronic low back pain due to herniated disc: analytical cross-sectional study. Sao Paulo Med J. 2010;128(5):259-62. doi: 10.1590/s1516-31802010000500003.

    PubMed 21181064

  • Patel VB, Wasserman R, Imani F. Interventional Therapies for Chronic Low Back Pain: A Focused Review (Efficacy and Outcomes). Anesth Pain Med. 2015 Aug 22;5(4):e29716. doi: 10.5812/aapm.29716. eCollection 2015 Aug.

    PubMed 26484298

  • Harris JD. Management of expected and unexpected opioid-related side effects. Clin J Pain. 2008 May;24 Suppl 10:S8-S13. doi: 10.1097/AJP.0b013e31816b58eb.

    PubMed 18418226

  • Momenzadeh S, Koosha A, Kazempoor Monfared M, Bairami J, Zali A, Ommi D, Hosseini B, Hashemi M, Sayadi S, Aryani R, Nematollahi F, Nematollahi L, Barati M. The Effect of Percutaneous Laser Disc Decompression on Reducing Pain and Disability in Patients With Lumbar Disc Herniation. J Lasers Med Sci. 2019 Winter;10(1):29-32. doi: 10.15171/jlms.2019.04. Epub 2018 Dec 15.

    PubMed 31360365

  • Schneider B, Zheng P, Mattie R, Kennedy DJ. Safety of epidural steroid injections. Expert Opin Drug Saf. 2016 Aug;15(8):1031-9. doi: 10.1080/14740338.2016.1184246. Epub 2016 May 13.

    PubMed 27148630

  • Choy DS. Percutaneous laser disc decompression. J Clin Laser Med Surg. 1995 Jun;13(3):125-6. doi: 10.1089/clm.1995.13.125.

    PubMed 10150634

  • Budrovac D, Rados I, Hnatesen D, Harsanji-Drenjancevic I, Tot OK, Katic F, Lukic I, Skiljic S, Neskovic N, Dimitrijevic I. Effectiveness of Epidural Steroid Injection Depending on Discoradicular Contact: A Prospective Randomized Trial. Int J Environ Res Public Health. 2023 Feb 19;20(4):3672. doi: 10.3390/ijerph20043672.

    PubMed 36834367

Questions about this trial

What is this clinical trial studying?

A study testing Epidural Steroid Injection and Percutaneous Laser Disc Decompression in people with Herniated Disc and Low Back Pain, run by Osijek University Hospital at 1 site in Croatia.

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 7 inclusion and 12 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 3 Nov 2022. 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 Croatia. 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 Dino Budrovac, MD (+385995162489, dino.budrovac@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the effectiveness in reducing pain intensity with ESI TF and PLDD in patients with lumbar radicular pain caused by intervertebral disc herniation (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05601791, which also lists 13 linked publications.

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 3 Nov 2022.

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