Automatic Grading of Disc Herniation, Central Canal Stenosis and Nerve Roots Compression in Lumbar Magnetic Resonance Image Diagnosis.
Zhi-Hai Su, Jin Liu, Min-Sheng Yang...
https://pubmed.ncbi.nlm.nih.gov/35733770Actively Recruiting
Phase Not Applicable
Age: 21Years - 75Years
All Genders
ID06611397
Double-Blinded Pilot Feasibility Study of the Discogen Device to Alleviate Discogenic Back and Radicular Leg Pain
Led by Columbia University · Updated on 2026-04-09
5
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
D
Discogen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a double-blinded, randomized controlled pilot feasibility study to evaluate the Discogen device for treating discogenic back and radicular leg pain. The study involves 40 adults with unilateral radicular leg pain related to disc disease or herniation at specific lumbar levels. The goal is to investigate the safety and feasibility of the Discogen device and measure its effect on pain reduction over 60 days. Participants will be randomly assigned to one of two groups. The treatment group will receive three daily unilateral Discogen low pulsed ultrasound treatments within one week, each lasting 25 minutes. The control group will receive three sham treatments over the same schedule without active ultrasound. Both groups may continue to use medications like NSAIDs or muscle relaxants for pain as needed. During the study, participants will be monitored for adverse events and changes in pain levels using the Numerical Pain Scale at 30 and 60 days. Additional assessments include changes in disability measured by the Oswestry Disability Index. Participants will complete study forms and attend follow-up visits, with safety and effectiveness outcomes collected over the 60-day period.
CONDITIONS
Brief Title
Discogen for Low Back Pain
Who Can Participate
Age: 21Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged over 21 years and up to 75 years, legally able and willing to participate and provide consent
- Able and willing to complete study forms and communicate with the investigator
- Having unilateral radicular leg pain with or without axial back pain lasting more than 1 month
- No epidural injections at the treatment site within the last three months
- Leg pain score of 4 to 9 on the Numerical Pain Scale in the last month
- Clinical signs of sensory radiculopathy from single-level disc disease or herniation at L3-4, L4-5, or L5-S1
- MRI showing disc disease/herniation at L3-4, L4-5, or L5-S1 with mild to moderate foraminal or spinal stenosis less than 50%
You will not qualify if you...
- Pregnant or breastfeeding
- Younger than 21 or older than 75 years
- Presence of motor deficits
- Baseline Oswestry Disability Index score of 41% or higher indicating severe disability or worse
- Presence of metal hardware in the lumbosacral spine
- History of spine surgery at the treatment level
- Lumbar spine conditions increasing procedural risk or symptoms unrelated to study
- Severe lumbar central canal stenosis greater than 50%
- Severe lumbar foraminal stenosis greater than 50%
- Severe herniated lumbar disc of Grade 2 or above
- Lumbar instability greater than Grade 1 spondylolisthesis
- Inability to understand or complete research questionnaires
- Severe medical conditions preventing safe treatment or outcome reporting
- Body mass index greater than 30
- Implanted spinal stimulators
- Epidural injections at the treatment site within the last three months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 week
Participants receive three daily unilateral treatments with the Discogen device or sham control over one work week. Each treatment lasts approximately 25 minutes.
3 visits (in-person, daily over one week)
Follow-up
Duration - 60 days
Participants are monitored for safety and effectiveness outcomes including pain and disability assessments.
2 visits (in-person at 30 and 60 days post-treatment)
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
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Research Team
C
Clark Smith, MD, PhD
M
Michael Spinner, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Short-term effects of high-intensity laser therapy versus ultrasound therapy in the treatment of low back pain: a randomized controlled trial.
P Fiore, F Panza, G Cassatella...
https://pubmed.ncbi.nlm.nih.gov/21654616