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Procedure

Discogen for Low Back Pain

N/A

Waitlist Available

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presenting with unilateral radicular leg pain with or without axial back pain of >1 month duration

Leg NPS pain score of 4 - 9 in the last month (on a scale of 0 to 10)

Must not have

History of spine surgery at the level of treatment

Lumbar instability on flexion/extension plain films, greater than Grade 1 spondylolisthesis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 and 60 days.

Summary

This trial will test a new treatment called Discogen on 40 participants at a study site in the United States. Half of the participants will receive the Discogen treatment, while the other half will receive

Who is the study for?

This trial is for individuals with lower back pain due to disc herniations or displacement. Participants must be eligible for the study based on specific criteria set by the researchers, which are not detailed here.

What is being tested?

The trial is testing a new low pulsed ultrasound treatment called Discogen against a sham (fake) treatment in people with back pain from disc issues. It's a small test of 40 people at one U.S. location, split into two groups randomly and conducted without either group knowing which treatment they're getting.

What are the potential side effects?

Possible side effects are not specified but may include reactions similar to those experienced with other ultrasound treatments or discomforts related to the condition being treated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had leg pain from a nerve issue, with or without back pain, for over a month.

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My leg pain has been between 4 and 9 out of 10 in the past month.

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I have nerve pain from a single disc herniation in my lower back.

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My MRI shows disc disease or herniation at L3-S1 without severe spinal narrowing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had spine surgery where my current treatment is focused.

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My lower back has significant instability or slippage.

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I have a severe narrowing in my lower back spinal canal.

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I am either younger than 21 or older than 75.

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I am experiencing difficulties with movement.

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I have severe back pain that greatly limits my daily activities.

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My lower back has a severe narrowing of the spinal canal.

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I have a severe herniated disc in my lower back.

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My BMI is over 30.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 and 60 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 and 60 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 and 60 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Effectiveness

Primary Safety

Secondary study objectives

Change from baseline in Oswestry Disability Index

Numerical Pain Scale (NPS)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment GroupExperimental Treatment1 Intervention

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.

Group II: Sham Control GroupPlacebo Group1 Intervention

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

0 / 13Eligibility criteria met