Discogen for Low Back Pain
ConditionDisc Herniation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Discogen Low pulsed ultrasound treatment
DeviceThe 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
DeviceThe 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
Treatment groups
5 Participants
are divided into 2 treatment groupsGroup A: Treatment GroupExperimental treatment 1 intervention
Group B: Sham Control GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Effectiveness
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).
Time frame
30 and 60 days.2
Primary Safety
Collection of all adverse events, including any device or procedure-related adverse events.
Time frame
60 daysSecondary outcomes
1
Change from baseline in Oswestry Disability Index
The Oswestry Disability Index is a patient-reported assessment of level of function (disability) in those living with low back pain. The Index ranges from 0-20% (minimal disability), 21-40% (moderate disability), 41-60% (severe disability), 61-80% (crippled), to 81-100% (bed bound).
Time frame
30 and 60 days.2
Numerical Pain Scale (NPS)
Percent change from baseline NPS back pain. The scale ranges from 0 (No pain) to 10 (Severe pain).
Time frame
30 and 60 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Discogen
Collaborator
Source ClinicalTrials.gov