High-Intensity Laser Therapy Versus Transforaminal Epidural Steroid Injection in Chronic Lumbar D… (NCT07688915) | Clinical Trial Compass
RecruitingNot Applicable
High-Intensity Laser Therapy Versus Transforaminal Epidural Steroid Injection in Chronic Lumbar Disc Herniation-Related Low Back and Radicular Pain
Turkey (Türkiye)24 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing high-intensity laser therapy against transforaminal epidural steroid injections for my type of pain — based on my specific disc herniation and symptoms, which of these two treatments does my doctor think is more appropriate for me, and why?
2Since this trial is listed as Phase NA, meaning it's comparing two existing treatments rather than testing a brand-new drug, what does my doctor think about how much is already known about the safety and effectiveness of each option — and does that change whether joining this trial makes sense versus just getting one of these treatments outside of a trial?
3The trial measures pain changes using a Visual Analog Scale for both back and leg pain — if I enroll, how will my doctor and the study team decide which treatment I'm assigned to, and is there a chance I'd be assigned to the option my doctor thinks is less suited for me personally?
4Given that my condition is chronic lumbar disc herniation with radicular pain, are there standard treatment steps — like physical therapy or oral medications — that my doctor thinks I should try or finish before considering either of these interventions, whether inside or outside this trial?
5What are the practical demands of participating in this study — how many visits are required, how long does each treatment take, and how would that fit with my daily life and ability to travel to the trial site?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Low Back and Leg Pain Intensity Assessed by Visual Analog Scale
Timeframe: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment