Lumbar Disc HerniationNCT07688915
High-Intensity Laser Therapy Versus Transforaminal Epidural Steroid Injection in Chronic Lumbar Disc Herniation-Related Low Back and Radicular Pain
A study testing High-Intensity Laser Therapy and Transforaminal Epidural Steroid Injections in people with Lumbar Disc Herniation and Chronic Low Back Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation, Chronic Low Back Pain, Radicular Pain
- What is being tested?
- High-Intensity Laser Therapy and Transforaminal Epidural Steroid Injections
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
Ankara
esra ülgen kıratlıoğlu, +905079614194, esraulgen@gmail.com
About this study
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
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.
Read the 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.
- Being tested
- High-Intensity Laser Therapy, Transforaminal Epidural Steroid Injections
- 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
- Medical subject headings
- Intervertebral Disc Displacement, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Laser TherapyDevice
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.
Transforaminal Epidural Steroid InjectionsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Transforaminal Epidural Steroid Injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment
Secondary outcomes (4)
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Aug 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two parallel groups: high-intensity laser therapy and transforaminal epidural steroid injection.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Ülgen Kıratlıoğlu, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688915
- Sponsor's protocol ID
- TABED 1-25-1769
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07688915
- Acronym / sponsor ID
- TABED 1-25-1769
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel groups: high-intensity laser therapy and transforaminal epidural steroid injection.
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Laser Therapy | Experimental | Device: High-Intensity Laser TherapyParticipants 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. |
| Transforaminal Epidural Steroid Injection | Active comparator | Procedure: Transforaminal Epidural Steroid InjectionsParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- Pregnancy or suspected pregnancy
- Presence of a cardiac pacemaker
- History of epilepsy
- Active or previous malignancy
- History of spinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Laser TherapyHigh-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. | Device | High-Intensity Laser Therapy |
| Transforaminal Epidural Steroid InjectionsFluoroscopy-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. | Procedure or surgery | Transforaminal Epidural Steroid Injection |
Primary outcome
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
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Laser Therapy and Transforaminal Epidural Steroid Injections in people with Lumbar Disc Herniation and Chronic Low Back Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esra Ülgen Kıratlıoğlu, MD (+905079614194, esraulgen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.