Discogen for Low Back Pain

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06611397
Status
Recruiting
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Conditions

  • Disc Herniation

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Discogen Low pulsed ultrasound treatment — DEVICE
    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
  • Discogen Sham Treatment — DEVICE
    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

Study 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.

Key Dates

Start date
Mar 15, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
5 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Primary Effectiveness [ Time Frame: 30 and 60 days. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Michael Spinner
[email protected]
5164594518

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By research site
Columbia University Irving Medical Center· New York, NY

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