Discogen for Low Back Pain

NARecruitingINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

March 15, 2025

Primary Completion Date

March 15, 2026

Study Completion Date

March 1, 2027

Conditions
Disc Herniation
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

Trial Locations (1)

10032

RECRUITING

Columbia University Irving Medical Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Discogen

UNKNOWN

lead

Columbia University

OTHER