Discogen for Low Back Pain

NCT06611397 | Recruiting FDA Device

• 1 other identifier: AAAU8219
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Disc Herniation

Keywords

Disc Herniation

Outcome Measures

Primary Outcomes (2)

• 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).

  30 and 60 days.

• Primary Safety

  Collection of all adverse events, including any device or procedure-related adverse events.

  60 days

Secondary Outcomes (2)

• Change from baseline in Oswestry Disability Index

  30 and 60 days.

• Numerical Pain Scale (NPS)

  30 and 60 days.

Study Arms (2)

Treatment Group

EXPERIMENTAL

Study subjects in the treatment group (Arm 1) will receive 3 daily Discogen treatments unilaterally within a one week (M-M) period, each lasting 25 minutes.

Device: Discogen Low pulsed ultrasound treatment

Sham Control Group

SHAM COMPARATOR

Subjects in the sham control arm (Arm 2) will receive 3 daily non-powered treatments unilaterally within a one week (M-M) period, each lasting 25 minutes

Device: Discogen Sham Treatment

Interventions

Discogen Sham Treatment DEVICE

The 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

Sham Control Group

Discogen Low pulsed ultrasound treatment DEVICE

The 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

Treatment Group

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject may be included in the study if the following conditions are met:
• 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
• Leg NPS pain score of 4 - 9 in the last month (on a scale of 0 to 10)
• Clinical presentation of sensory radiculopathy referable to single-level disc disease/herniation at L3-4, L4-5 or L5-S1
• 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%).

You may not qualify if:

• 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)
• Presence of metal hardware within the lumbosacral spine
• History of spine surgery at the level of treatment.
• 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)
• Severe lumbar central canal stenosis (greater than 50%)
• Severe lumbar foraminal stenosis (greater than 50%)
• Severe herniated lumbar disc 4(Grade 2 and above)
• Lumbar instability on flexion/extension plain films, greater the Grade 1 spondylolisthesis
• Unable to understand and complete research questionnaires
• Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcomes.
• BMI greater than 30
• Implanted spinal stimulators

Sponsors & Collaborators

• Columbia University: lead
• Discogen: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 35733770 RESULT

• PASS 2021 Power Analysis and Sample Size Software (2021). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.

  RESULT

• 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.

  PMID: 21654616 RESULT

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Clark Smith, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clark Smith, MD, PhD

CONTACT

212-305-2134; cs3028@cumc.columbia.edu

Michael Spinner, MS

CONTACT

212-305-9416; ms6431@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Rehabilitation and Regenerative Medicine

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 25, 2024
• Study Start: March 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)