Disc HerniationNCT06611397
Discogen for Low Back Pain
A study testing Discogen Low pulsed ultrasound treatment in people with Disc Herniation, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Disc Herniation
- What is being tested?
- Discogen Low pulsed ultrasound treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2025to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
Who cannot join
- 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.
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Michael Spinner, 5164594518, ms6431@cumc.columbia.edu
About this study
Official title: Double-Blinded Pilot Feasibility Study of the Discogen Device to Alleviate Discogenic Back/Radicular Leg Pain
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.
Read the 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.
- Investigate the safety and feasibility of the Discogen device to alleviate back/radicular leg pain
- 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
- Conditions
- Disc Herniation
- Being tested
- Discogen Low pulsed ultrasound treatment, Discogen Sham Treatment
- Keywords
- Disc Herniation
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discogen Low pulsed ultrasound treatmentDevice
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
Discogen Sham TreatmentDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Discogen Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 and 60 days.
Primary Safety
Collection of all adverse events, including any device or procedure-related adverse events.
Measured: 60 days
Secondary outcomes (2)
Change from baseline in Oswestry Disability Index
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).
Measured: 30 and 60 days.
Numerical Pain Scale (NPS)
Percent change from baseline NPS back pain. The scale ranges from 0 (No pain) to 10 (Severe pain).
Measured: 30 and 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start15 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Disc HerniationStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Discogen
- Responsible party
- Principal investigator, Clark Smith, Columbia University
- Investigators
- Clark Smith, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611397
- Sponsor's protocol ID
- AAAU8219
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 35733770PASS 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.
PubMed 21654616
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blinded Pilot Feasibility Study of the Discogen Device to Alleviate Discogenic Back/Radicular Leg Pain
- ClinicalTrials.gov ID
- NCT06611397
- Acronym / sponsor ID
- AAAU8219
- Conditions
- Disc Herniation
- Keywords
- Disc Herniation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Discogen
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Investigate the safety and feasibility of the Discogen device to alleviate back/radicular leg pain
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Discogen Low pulsed ultrasound treatmentStudy 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. |
| Sham Control Group | Sham comparator | Device: Discogen Sham TreatmentSubjects 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 |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discogen Low pulsed ultrasound treatmentThe 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 | Device | Treatment Group |
| Discogen Sham TreatmentThe 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 | Device | Sham Control Group |
Primary outcome
Primary Effectiveness
Time frame: 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
Time frame: 60 days
Collection of all adverse events, including any device or procedure-related adverse events.
2 secondary outcomes
Change from baseline in Oswestry Disability Index
Time frame: 30 and 60 days.
Numerical Pain Scale (NPS)
Time frame: 30 and 60 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Results publication: PubMed 35733770Su 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.
- Results publicationPASS 2021 Power Analysis and Sample Size Software (2021). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
- Results publication: PubMed 21654616Fiore 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clark Smith, MD, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discogen Low pulsed ultrasound treatment in people with Disc Herniation, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clark Smith, MD, PhD (212-305-2134, cs3028@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness (time frame: 30 and 60 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611397, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.