Discogen for Low Back Pain

Not Applicable

Recruiting

• Conditions: Disc Herniation

• Registration Number: NCT06611397
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

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. This study will enroll 40 evaluable subjects and follow them for 60 days.

1. Investigate the safety and feasibility of the Discogen device to alleviate back/radicular leg pain

2. Assess the mean reduction in back and radicular leg pain following Discogen treatment.

* Primary Safety - collection of all adverse events, including any device- or procedure-related adverse events

* Primary Effectiveness -percent change from baseline for Numerical Pain Scale (NPS) radicular leg pain at 30 and 60 days. The scale ranges from 0(No pain) to 10 (Severe pain).

* Secondary Effectiveness:

* Change from baseline in Oswestry Disability Index at 30 and 60 days. The Index ranges from 0-20% (minimal disability), 21-40% (moderate disability), 41-60% (severe disability), 61-80% (crippled), to 81-100% (bed bound).

* Percent change from baseline NPS back pain at 30 and 60 days

Study Timeline

• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Study First Posted: 2024-09-25
• Study Start: 2025-03-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-03-15
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

1. Pregnant or breastfeeding patient
2. Younger than 21 or older than 75 years
3. Presenting with motor deficits
4. Presenting with a baseline Oswestry Disability Index ≥ 41% (severe disability or worse)
5. Presence of metal hardware within the lumbosacral spine
6. History of spine surgery at the level of treatment.
7. Lumbar spine pathology that may increase procedural risk and/or influence symptoms and/or generate unrelated adverse events (per the discretion of the study PI)
8. Severe lumbar central canal stenosis (greater than 50%)
9. Severe lumbar foraminal stenosis (greater than 50%)
10. Severe herniated lumbar disc 4(Grade 2 and above)
11. Lumbar instability on flexion/extension plain films, greater the Grade 1 spondylolisthesis
12. Unable to understand and complete research questionnaires
13. Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcomes.
14. BMI greater than 30
15. Implanted spinal stimulators
16. Epidural injections at treatment site within the last three months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness	30 and 60 days.	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).
Primary Safety	60 days	Collection of all adverse events, including any device or procedure-related adverse events.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Oswestry Disability Index	30 and 60 days.	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).
Numerical Pain Scale (NPS)	30 and 60 days.	Percent change from baseline NPS back pain. The scale ranges from 0 (No pain) to 10 (Severe pain).

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States