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NCT Number: NCT07688915

High-Intensity Laser Therapy Versus Transforaminal Epidural Steroid Injection in Chronic Lumbar Disc Herniation-Related Low Back and Radicular Pain

This prospective, randomized, single-blinded, controlled clinical trial aims to compare the effectiveness of high-intensity laser therapy and fluoroscopy-guided transforaminal epidural steroid injection in patients with chronic low back pain and lumbar radiculopathy. Eligible patients will be randomized into two parallel groups. One group will receive high-intensity laser therapy, and the other group will receive transforaminal epidural steroid injection. All participants will also receive a standardized home-based exercise program. Outcomes will be assessed at baseline, 2 weeks, 6 weeks, and 12 weeks after treatment. The primary outcome will be pain intensity measured by the Visual Analog Scale. Secondary outcomes will include functional disability, neuropathic pain symptoms, quality of life, and functional walking capacity.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Ankara, Turkey (Türkiye)

Location status: Recruiting

Location contact

esra ülgen kıratlıoğlu

CONTACT

[email protected]

+905079614194

About this study

Low back pain is one of the most common musculoskeletal complaints and may lead to substantial disability and reduced quality of life. Lumbar disc herniation is a frequent cause of chronic axial and radicular low back pain.

High-intensity laser therapy is a non-invasive physical therapy modality with analgesic, anti-inflammatory, and biostimulatory effects. Transforaminal epidural steroid injection is a minimally invasive interventional treatment commonly used for radicular pain associated with lumbar disc herniation.

This prospective randomized controlled trial will include adult patients aged 18 to 65 years with chronic axial and radicular low back pain due to lumbar disc herniation. Participants will be randomized into two parallel groups. One group will receive high-intensity laser therapy for 15 sessions over 3 weeks, and the other group will receive fluoroscopy-guided transforaminal epidural steroid injection. All participants will receive a standardized home-based exercise program. Outcomes will be assessed at baseline, 2 weeks, 6 weeks, and 12 weeks after treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 65 years
  • Diagnosis of lumbar disc herniation confirmed by clinical examination and lumbar magnetic resonance imaging
  • Chronic axial low back pain and radicular pain related to lumbar disc herniation
  • Low back and/or radicular pain lasting longer than 3 months
  • Resting low back and/or radicular pain intensity of ≥5 on a 0-10 visual analog scale
  • Willingness to participate in the study and provide written informed consent

Exclusion criteria

  • Pregnancy or suspected pregnancy
  • Presence of a cardiac pacemaker
  • History of epilepsy
  • Active or previous malignancy
  • History of spinal surgery
  • Uncontrolled systemic or psychiatric disease
  • Cauda equina syndrome or progressive neurological deficit
  • Peripheral neuropathy, including diabetic or alcohol-related neuropathy
  • Neurodegenerative disease
  • Acute trauma
  • Active systemic infection
  • Local infection or skin disease at the injection site or treatment area
  • Body mass index greater than 40 kg/m²
  • Bleeding disorder that contraindicates treatment
  • Spinal stenosis, spondylolysis, or spondylolisthesis
  • Neurogenic bladder or bowel syndrome
  • Rheumatologic disease
  • Arterial vascular disease or vascular claudication
  • Receipt of other physical therapy modalities within the last 3 months
  • Receipt of spinal injection therapy within the last 3 months
  • History of allergy to injection agents

Treatment and study plan

High-intensity laser therapy

Device

High-intensity laser therapy will be applied using a pulsed Nd:YAG laser with a wavelength of 1064 nm. Treatment will be delivered in 15 sessions over 3 weeks to the lumbar paravertebral region. Each session will last approximately 10-12 minutes with a total energy dose of 2500 joules.

Transforaminal Epidural Steroid Injections

Procedure

Fluoroscopy-guided transforaminal epidural steroid injection will be performed by an experienced physical medicine and rehabilitation specialist. After confirmation of needle placement with contrast medium, 2 mL of 2% lidocaine hydrochloride and 8 mg/2 mL dexamethasone will be administered.

Primary outcomes

  1. Change in Low Back and Leg Pain Intensity Assessed by Visual Analog Scale

    Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment

    Pain intensity at rest will be assessed using the visual analog scale. Participants will be asked to indicate their current low back and radicular leg pain intensity on a 10-cm horizontal line, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.

Secondary outcomes

  1. Change in Disability Assessed by the Oswestry Disability Index

    Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment

    Disability related to low back pain will be assessed using the Oswestry Disability Index. The questionnaire includes 10 sections evaluating pain intensity and the effect of pain on daily activities. The total score is converted to a percentage from 0 to 100, with higher scores indicating greater disability.

  2. Change in Neuropathic Pain Assessed by the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale

    Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment

    Neuropathic pain features will be assessed using the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale. The scale consists of symptom-based and examination-based items. A total score of 12 or higher suggests neuropathic pain, while a score below 12 suggests nociceptive pain.

  3. Change in Health-Related Quality of Life Assessed by the Short Form-36 Health Survey

    Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment

    Health-related quality of life will be assessed using the Short Form-36 Health Survey. The questionnaire includes eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, vitality, mental health, social functioning, bodily pain, and general health perception. Each domain is scored from 0 to 100, with higher scores indicating better health status.

  4. Change in Functional Walking Capacity Assessed by the Six-Minute Walk Test

    Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment

    Functional walking capacity will be assessed using the Six-Minute Walk Test. Participants will be instructed to walk as far as possible along a flat walking area for 6 minutes. The total distance walked in meters will be recorded, with longer distances indicating better functional walking capacity.

Study contacts

Contact information is provided by the study sponsor or research team.

Esra Ülgen Kıratlıoğlu, MD

CONTACT

[email protected]

+905079614194

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Comparison of the Effectiveness of High-Intensity Laser Therapy and Transforaminal Epidural Steroid Injection in Patients With Chronic Axial and Radicular Low Back Pain Due to Lumbar Disc Herniation: A Prospective Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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