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.
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
Pregnancy or suspected pregnancy
Presence of a cardiac pacemaker
History of epilepsy
Active or previous malignancy
Parallel
High-Intensity Laser Therapy
DeviceHigh-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/SurgeryFluoroscopy-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.
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.
Change in Disability Assessed by the Oswestry Disability Index
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.
Change in Neuropathic Pain Assessed by the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale
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.
Change in Health-Related Quality of Life Assessed by the Short Form-36 Health Survey
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.
Change in Functional Walking Capacity Assessed by the Six-Minute Walk Test
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.
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