Discogen for Low Back Pain

Study Purpose

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	21 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria.The subject may be included in the study if the following conditions are met: 1. Adult (> 21 y.o.) males and females legally able and willing to participate and provide consent in the study and attend follow-up visits. 2. Able and willing to complete study forms and communicate with the investigator. 3. Presenting with unilateral radicular leg pain with or without axial back pain of >1 month duration. 4. No epidural injections at treatment site within the last three months. 5. Leg NPS pain score of 4

- 9 in the last month (on a scale of 0 to 10) 6.

Clinical presentation of sensory radiculopathy referable to single-level disc disease/herniation at L3-4, L4-5 or L5-S1. 7. 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:

1. Pregnant or breastfeeding patient. 2. Younger than 21 or older than 75 years. 3. Presenting with motor deficits. 4. Presenting with a baseline Oswestry Disability Index ≥ 41% (severe disability or worse) 5. Presence of metal hardware within the lumbosacral spine. 6. History of spine surgery at the level of treatment. 7. 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) 8. Severe lumbar central canal stenosis (greater than 50%) 9. Severe lumbar foraminal stenosis (greater than 50%) 10. Severe herniated lumbar disc 4(Grade 2 and above) 11. Lumbar instability on flexion/extension plain films, greater the Grade 1 spondylolisthesis. 12. Unable to understand and complete research questionnaires. 13. Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcomes. 14. BMI greater than 30. 15. Implanted spinal stimulators. 16. Epidural injections at treatment site within the last three months

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06611397
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Columbia University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Disc Herniation

Additional Details

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. This study will enroll 40 evaluable subjects and follow them for 60 days. 1. Investigate the safety and feasibility of the Discogen device to alleviate back/radicular leg pain. 2. Assess the mean reduction in back and radicular leg pain following Discogen treatment.

- Primary Safety - collection of all adverse events, including any device- or procedure-related adverse events.

- Primary Effectiveness -percent change from baseline for Numerical Pain Scale (NPS) radicular leg pain at 30 and 60 days.

The scale ranges from 0(No pain) to 10 (Severe pain).

- Secondary Effectiveness: - Change from baseline in Oswestry Disability Index at 30 and 60 days.

The Index ranges from 0-20% (minimal disability), 21-40% (moderate disability), 41-60% (severe disability), 61-80% (crippled), to 81-100% (bed bound). - Percent change from baseline NPS back pain at 30 and 60 days

Arms & Interventions

Arms

Experimental: Treatment Group

Study subjects in the treatment group (Arm 1) will receive 3 daily Discogen treatments unilaterally within a one week (M-M) period, each lasting 25 minutes.

Sham Comparator: Sham Control Group

Subjects in the sham control arm (Arm 2) will receive 3 daily non-powered treatments unilaterally within a one week (M-M) period, each lasting 25 minutes

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York, New York

Status

Recruiting

Address

Columbia University Irving Medical Center

New York, New York, 10032

Site Contact

Michael Spinner

[email protected]

5164594518

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