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
Qualifiers
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
Treatments tested in this trial
- Discogen Low pulsed ultrasound treatment
- Discogen Sham Treatment
Treatment groups
5 Participants
are divided into 2 treatment groupsSponsors and collaborators
Columbia University
Lead sponsor
Discogen
Collaborator
Source ClinicalTrials.gov