Chronic Low Back Pain, Lumbar Disc Herniation, Lumbar Radiculopathy, Radicular Pain
Conditions
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
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.
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
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.
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.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will be blinded to treatment allocation.
Intervention model description
Participants will be randomized into two parallel groups: high-intensity laser therapy and transforaminal epidural steroid injection.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Low Back and Leg Pain Intensity Assessed by Visual Analog Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Disability Assessed by the Oswestry Disability Index | 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. |
| 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 | 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 | 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. |
| Change in Functional Walking Capacity Assessed by the Six-Minute Walk Test | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTEsra Ülgen Kıratlıoğlu, MD
Outcome results
None listed