NCT06611397 · Columbia University
Discogen for Low Back Pain
What this study is about
This study will be a double-blinded, two-treatment group$1, forward-looking, randomly assigned controlled pilot feasibility study in 40 evaluable subjects (20 in each treatment group$1) at one study site within the United States. Subjects in treatment group$1 1 will receive unilateral Discogen treatment; subjects in treatment group$1 2 will receive unilateral sham treatment (control).
View original scientific description
This study will be a double-blinded, two-arm, prospective, randomized controlled pilot feasibility study in 40 evaluable subjects (20 in each arm) at one study site within the United States. Subjects in Arm 1 will receive unilateral Discogen treatment; subjects in Arm 2 will receive unilateral sham treatment (control). Treatment in both arms can include medications, e.g. NSAIDs or muscle relaxants for axial or radicular pain.
Interventions
DEVICE
Discogen Low pulsed ultrasound treatment
The device is a customized Low Intensity Pulsed Ultrasound (LIPUS) transducer system and power source. The transducer is biocompatible for skin contact. The system is capable of calibration to desired treatment parameters. The study subject will be placed in the prone position with all appropriate pressure points padded on the exam table. For the first treatment, fluoroscopic imaging (and/or ultrasonic guidance) will be used to guide the placement of the transducer over the anatomic target, unilateral at the L3-4, L4-5 or L5-S1 levels. The skin of the study subject's back will be marked with non-washable marking pen to indicate the site for placing the transducer during the first treatment. The subsequent treatment (second and third) can be done without using ultrasound guidance. The transducer will be placed on the marked site during the second and third treatment. The ultrasound signal will be delivered unilaterally for 25 minutes, using a timer visible to the patient. The power ge
DEVICE
Discogen Sham Treatment
The ultrasound signal will be delivered unilaterally for 25 minutes, using a timer visible to the patient. The power generator will not be turned on for the sham treatment, but the wave generator will be displayed. All study subjects will receive a total of three daily Discogen treatments over the span of a single M-M work week
Primary outcome measures
Primary Effectiveness
Time frame: 30 and 60 days.
Percent change from baseline for Numerical Pain Scale (NPS) radicular leg pain at 30 and 60 days. The NPS is a patient-reported assessment of pain intensity, ranging from 0 (No pain) to 10 (Severe pain).
Primary Safety
Time frame: 60 days
Collection of all adverse events, including any device or procedure-related adverse events.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The subject may be included in the study if the following conditions are met:
- Adult (\> 21 y.o.) males and females legally able and willing to participate and provide consent in the study and attend follow-up visits
- Able and willing to complete study forms and communicate with the investigator
- Presenting with unilateral radicular leg pain with or without axial back pain of \>1 month duration
- No epidural injections at treatment site within the last three months
- Leg NPS pain score of 4 - 9 in the last month (on a scale of 0 to 10)
- Clinical presentation of sensory radiculopathy referable to single-level disc disease/herniation at L3-4, L4-5 or L5-S1
- MRI lumbar spine negative for extruded disc herniation, tumor, or bleeding, but positive for disc disease/herniation at L3-4, L4-5 or L5-S1 with mild to moderate foraminal or spinal stenosis (less than 50%).
Exclusion criteria
- Pregnant or breastfeeding patient
- Younger than 21 or older than 75 years
- Presenting with motor deficits
- Presenting with a baseline Oswestry Disability Index ≥ 41% (severe disability or worse)
- Presence of metal hardware within the lumbosacral spine
- History of spine surgery at the level of treatment.
- Lumbar spine pathology that may increase procedural risk and/or influence symptoms and/or generate unrelated adverse events (per the discretion of the study PI)
- Severe lumbar central canal stenosis (greater than 50%)
- Severe lumbar foraminal stenosis (greater than 50%)
- Severe herniated lumbar disc 4(Grade 2 and above)
- Lumbar instability on flexion/extension plain films, greater the Grade 1 spondylolisthesis
- Unable to understand and complete research questionnaires
- Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcomes.
- BMI greater than 30
- Implanted spinal stimulators
- Epidural injections at treatment site within the last three months
Where
- New York, New York
Collaborators
Discogen
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations