Discogen for Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-15

Study Completion Date

2027-03-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Disc Herniation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment Group

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 Type EXPERIMENTAL

Discogen Low pulsed ultrasound treatment

Intervention Type 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

Sham Control Group

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

Group Type SHAM_COMPARATOR

Discogen Sham Treatment

Intervention Type 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

Interventions

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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, 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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No