Clinical trial NCT06611397: Discogen for Low Back Pain
Official title: Double-Blinded Pilot Feasibility Study of the Discogen Device to Alleviate Discogenic Back/Radicular Leg Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disc Herniation
Keywords: Disc Herniation
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Discogen
First posted: 2024-09-25
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria

The subject may be included in the study if the following conditions are met:

1. Adult (\> 21 y.o.) males and females legally able and willing to participate and provide consent in the study and attend follow-up visits
2. Able and willing to complete study forms and communicate with the investigator
3. Presenting with unilateral radicular leg pain with or without axial back pain of \>1 month duration
4. No epidural injections at treatment site within the last three months
5. Leg NPS pain score of 4 - 9 in the last month (on a scale of 0 to 10)
6. Clinical presentation of sensory radiculopathy referable to single-level disc disease/herniation at L3-4, L4-5 or L5-S1
7. MRI lumbar spine negative for extruded disc herniation, tumor, or bleeding, but positive for disc disease/herniation at L3-4, L4-5 or L5-S1 with mild to moderate foraminal or spinal stenosis (less than 50%).

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

Primary outcomes:
measure: Primary Effectiveness
timeFrame: 30 and 60 days.
measure: Primary Safety
timeFrame: 60 days
Secondary outcomes:
measure: Change from baseline in Oswestry Disability Index
timeFrame: 30 and 60 days.
measure: Numerical Pain Scale (NPS)
timeFrame: 30 and 60 days.
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Clark Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Su ZH, Liu J, Yang MS, Chen ZY, You K, Shen J, Huang CJ, Zhao QH, Liu EQ, Zhao L, Feng QJ, Pang SM, Li SL, Lu H. Automatic Grading of Disc Herniation, Central Canal Stenosis and Nerve Roots Compression in Lumbar Magnetic Resonance Image Diagnosis. Front Endocrinol (Lausanne). 2022 Jun 6;13:890371. doi: 10.3389/fendo.2022.890371. eCollection 2022.
citation: PASS 2021 Power Analysis and Sample Size Software (2021). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
citation: Fiore P, Panza F, Cassatella G, Russo A, Frisardi V, Solfrizzi V, Ranieri M, Di Teo L, Santamato A. Short-term effects of high-intensity laser therapy versus ultrasound therapy in the treatment of low back pain: a randomized controlled trial. Eur J Phys Rehabil Med. 2011 Sep;47(3):367-73. Epub 2011 Jun 8.