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

Official 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

Overview

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.

Detailed description

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.

Interventions

• Device High-Intensity Laser Therapy
  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.
• Procedure Transforaminal Epidural Steroid Injections
  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 outcome measures

• 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]

Secondary outcome measures (4)

• Change in Disability Assessed by the Oswestry Disability Index [Time frame: 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 [Time frame: 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 [Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment]
• Change in Functional Walking Capacity Assessed by the Six-Minute Walk Test [Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital — Ankara

Identifiers

NCT: NCT07688915 · TABED 1-25-1769

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗