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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esra Ülgen Kıratlıoğlu, MD | Contact | +905079614194 | esraulgen@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital | Recruiting | Ankara | Turkey (Türkiye) |
Individual participant data will not be shared due to privacy and ethical restrictions.
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Participants will be randomized into two parallel groups: high-intensity laser therapy and transforaminal epidural steroid injection.
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The outcomes assessor will be blinded to treatment allocation.
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| 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. |
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| 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. | 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 | 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. | Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment |
| 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. | Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment |
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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