Discogen for Low Back Pain

Official title

Double-Blinded Pilot Feasibility Study of the Discogen Device to Alleviate Discogenic Back/Radicular Leg Pain

Overview

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

Interventions

• Device Discogen Low pulsed ultrasound treatment
  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, unil
• Device Discogen Sham Treatment
  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

Primary outcome measures

• Primary Effectiveness [Time frame: 30 and 60 days.]
• Primary Safety [Time frame: 60 days]

Secondary outcome measures (2)

• Change from baseline in Oswestry Disability Index [Time frame: 30 and 60 days.]
• Numerical Pain Scale (NPS) [Time frame: 30 and 60 days.]

Eligibility criteria

Inclusion criteria

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%).

Exclusion criteria

• 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
• Epidural injections at treatment site within the last three months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Columbia University Irving Medical Center — New York

Publications

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

Identifiers

NCT: NCT06611397 · AAAU8219

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗