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

NCT07688915 | Recruiting

• 1 other identifier: TABED 1-25-1769
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low Back Pain; Radicular Pain; Lumbar Radiculopathy; Lumbar Disc Herniation

Keywords

High-intensity laser therapy; Transforaminal epidural steroid injection; Lumbar disc herniation; Chronic low back pain; Radicular pain; Lumbar radiculopathy; Visual analog scale; Oswestry Disability Index

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment

Secondary Outcomes (4)

• Change in Disability Assessed by the Oswestry Disability Index

  Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment

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

  Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment

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

  Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment

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

  Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment

Study Arms (2)

High-Intensity Laser Therapy

EXPERIMENTAL

Participants in this group will receive high-intensity laser therapy using a pulsed Nd:YAG laser device for 15 sessions over 3 weeks. Treatment will be applied to the lumbar paravertebral region using the lumbosciatalgia mode. All participants will also receive a home exercise program.

Device: High-Intensity Laser Therapy

Transforaminal Epidural Steroid Injection

ACTIVE COMPARATOR

Participants in this group will receive fluoroscopy-guided transforaminal epidural steroid injection. The injection level will be determined according to physical examination and lumbar magnetic resonance imaging findings. All participants will also receive a home exercise program.

Procedure: Transforaminal Epidural Steroid Injections

Interventions

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.

Transforaminal Epidural Steroid Injection

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.

High-Intensity Laser Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement; Radiculopathy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Esra Ülgen Kıratlıoğlu, MD

CONTACT

+905079614194; esraulgen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants will be randomized into two parallel groups: high-intensity laser therapy and transforaminal epidural steroid injection.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)