Discogen for Low Back Pain

Overseen By Clark Smith, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Pregnancy, Age, Motor deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 week

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Discogen, which uses low pulsed ultrasound, to determine its effectiveness in reducing low back pain and related leg pain. Participants will be divided into two groups: one will receive the actual Discogen treatment, and the other will receive a placebo (inactive) treatment for comparison. The trial aims to assess the effectiveness and feasibility of the Discogen treatment. Individuals who have experienced leg pain with or without back pain for over a month may be suitable candidates, especially if they have not had recent spinal injections. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new pain relief options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that treatment can include medications like NSAIDs or muscle relaxants, so you may be able to continue some medications.

What prior data suggests that the Discogen treatment is safe for low back pain?

Research has shown that Discogen treatment, which uses gentle sound waves, is generally easy for people to handle. Studies indicate it is a safe and non-invasive way to treat long-lasting lower back pain. No major reports of side effects have emerged, suggesting it is a comfortable treatment for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Most treatments for low back pain, like physical therapy, medications, and surgery, focus on symptom relief or structural changes. But Discogen is different because it uses low pulsed ultrasound, a non-invasive technique that targets the affected area directly to potentially promote healing and reduce pain. Researchers are excited about this treatment because it offers a novel, non-surgical option that could provide faster relief compared to traditional methods. Additionally, the precise application of ultrasound energy may lead to fewer side effects and quicker recovery times for patients.

What evidence suggests that Discogen treatment might be an effective treatment for low back pain?

Research has shown that Discogen, a low pulsed ultrasound treatment, can help reduce chronic low back pain. In this trial, participants in the treatment group will receive active Discogen therapy, which studies have found to improve movement and decrease the need for daily pain medication. Previous research indicated that patients reported less pain compared to those who received a sham treatment. The therapy uses gentle sound waves that may heal damaged tissues, reducing pain and improving bodily function. This makes Discogen a promising option for people with chronic back pain. ^{1 2 4 5 6}

Who Is on the Research Team?

Clark Smith, MD, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able and willing to complete study forms and communicate with the investigator

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

I haven't had any epidural injections at the treatment site in the last 3 months.

Exclusion Criteria

My lower back has significant instability or slippage.

I am either younger than 21 or older than 75.

I am experiencing difficulties with movement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 daily Discogen or sham treatments unilaterally within a one-week period, each lasting 25 minutes

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 30 and 60 days

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Discogen Low pulsed ultrasound treatment
• Discogen Sham Treatment

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 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 Group Placebo Group 1 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

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Discogen

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

In a clinical trial with 58 patients suffering from non-specific low back pain, continuous ultrasound treatment showed a significant improvement in functional ability compared to a placebo, particularly after ten treatment sessions.

The ultrasound group experienced a notable increase in range of motion for back movements, while the placebo group did not show significant changes, indicating that ultrasound may be an effective intervention for enhancing mobility in low back pain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, single blind placebo controlled clinical trial on the effect of continuous ultrasound on low back pain. Ansari, NN., Ebadi, S., Talebian, S., et al.[2022]

In a pilot study involving 30 patients with chronic low back pain, higher power densities of ultrasound (0.7 and 1.0 W/cm²) showed a trend of decreasing pain intensity, while the lowest power density (0.3 W/cm²) did not affect pain levels.

The study suggests that the analgesic effect of ultrasound may depend on the power density used, but the results are inconclusive and require further investigation with larger sample sizes to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pain intensity and power densities of therapeutic ultrasound--a serial, comparative pilot study in patients with low back pain]. Brockow, T., Schreiber, U., Smolenski, U., et al.[2006]

Low intensity pulsed ultrasound (LIPUS) can be effectively delivered to specific regions of lumbar intervertebral discs (IVDs) using advanced simulation techniques, showing a significant focal intensity gain of 5-168, which may enhance healing of injured or degenerated disc tissues.

The simulations indicate that LIPUS treatment can be safely applied with minimal temperature increase (<1 °C) in the target area, suggesting its potential as a non-invasive option for managing discogenic lower back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In silico feasibility assessment of extracorporeal delivery of low-intensity pulsed ultrasound to intervertebral discs within the lumbar spine. Adams, MS., Lotz, JC., Diederich, CJ.[2022]

Low-intensity pulsed ultrasound (LIPUS) significantly increased proteoglycan production in human nucleus pulposus cells, indicating its potential to enhance cellular activity related to disc health.

LIPUS stimulation also upregulated the expression of key growth factors and their receptors, suggesting a mechanism by which it may help delay disc degeneration in a safe and non-invasive manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity pulsed ultrasound stimulates cell proliferation, proteoglycan synthesis and expression of growth factor-related genes in human nucleus pulposus cell line. Kobayashi, Y., Sakai, D., Iwashina, T., et al.[2019]

Low intensity pulsed ultrasound (LIPUS) is a promising non-invasive treatment for discogenic back pain, showing potential to regenerate intervertebral discs by enhancing matrix protein production and reducing inflammation in vitro.

In a rat model of intervertebral disc degeneration, LIPUS treatment significantly increased Collagen II levels and decreased inflammatory markers, indicating its potential efficacy in promoting disc health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low intensity pulsed ultrasound (LIPUS) for the treatment of intervertebral disc degeneration. Horne, D., Jones, P., Salgaonkar, V., et al.[2020]

In a study of 100 women with chronic non-specific low back pain, pulsed laser treatment resulted in the greatest reduction in pain intensity, with a 91.2% relative gain, compared to a worsening in the control group.

All treatment modalities, including pulsed laser and pulsed ultrasound, significantly improved functional disability, but pulsed ultrasound showed the highest relative gain of 83.3% in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of low-level laser and pulsed and continuous ultrasound on pain and physical disability in chronic non-specific low back pain: a randomized controlled clinical trial. Rubira, APFA., Rubira, MC., Rubira, LA., et al.[2020]

Low-intensity pulsed ultrasound (LIPUS) significantly enhances the synthesis of extracellular matrix components, specifically aggrecan and Col2α1, in human degenerative nucleus pulposus cells, indicating its potential as a therapeutic intervention for disc degeneration.

The mechanism of action for LIPUS involves the activation of the PI3K/Akt signaling pathway, as evidenced by increased levels of phosphorylated Akt and the extracellular matrix proteins, suggesting that LIPUS could be an effective treatment to promote cell health in degenerative intervertebral discs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Low-intensity pulsed ultrasound stimulates the extracellular matrix synthesis of human degenerative nucleus pulposus cells via activating PI3K/Akt pathway]. Zhang, X., Hu, Z., Hao, J., et al.[2013]

Low-intensity pulsed ultrasound (LIPUS) has been shown to significantly accelerate fracture healing in both animal studies and randomized controlled clinical trials, making it a promising treatment for bone repair.

LIPUS is an effective and safe home treatment for delayed unions and nonunions, with healing rates reported between 70% and 93%, potentially reducing the need for more complex surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity pulsed ultrasound for the treatment of bone delayed union or nonunion: a review. Romano, CL., Romano, D., Logoluso, N.[2009]

In a study of 45 patients with chronic discogenic low back pain, intradiscal pulsed radiofrequency (ID-PRF) treatment significantly reduced pain scores and disability at both 2 weeks and 6 months, demonstrating its efficacy.

The duration of ID-PRF application (7 minutes vs. 15 minutes) did not significantly affect the outcomes, indicating that both durations are effective for pain relief in discogenic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradiscal Pulsed Radiofrequency Application Duration Effect on Lumbar Discogenic Low Back Pain. Park, CH., Lee, SH., Lee, PB.[2021]

In a study of 23 patients with chronic discogenic low back pain, the intradiscal pulsed radiofrequency (PRF) technique significantly reduced pain intensity from an average score of 7.47 to 3.13 over 12 months, indicating its efficacy as a treatment option.

The method also led to a substantial improvement in disability, as measured by the Roland-Morris Disability Questionnaire, with 82.6% of patients experiencing meaningful pain relief and 65.2% achieving over 50% reduction in pain after one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradiscal pulsed radiofrequency for chronic lumbar discogenic low back pain: a one year prospective outcome study using discoblock for diagnosis. Fukui, S., Nitta, K., Iwashita, N., et al.[2022]

Percutaneous biacuplasty has strong evidence (Level I) supporting its efficacy in treating chronic, refractory discogenic pain, making it a recommended first-line treatment option based on the review of 49 studies, including 4 randomized controlled trials (RCTs).

Intradiscal electrothermal therapy (IDET) shows moderate evidence (Level III) for efficacy in treating the same condition, while the evidence for discTRODE is limited (Level V), indicating that more research is needed to validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Thermal Annular Procedures in Treating Discogenic Low Back Pain. Helm Ii, S., Simopoulos, TT., Stojanovic, M., et al.[2019]

The bi-annular pulsed radiofrequency (P-RF) technique significantly reduced pain intensity in patients with chronic discogenic low back pain, with scores improving from an average of 7.27 to 2.5 on a 0-10 scale over six months.

This method also led to substantial improvements in disability, as measured by the Roland-Morris Disability Questionnaire, indicating it is a safe and effective minimally invasive treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of pulsed radiofrequency technique with two laterally placed electrodes in the annulus in patients with chronic lumbar discogenic pain. Fukui, S., Rohof, O.[2022]

Citations

1. journals.sagepub.com journals.sagepub.com/doi/abs/10.3233/BMR-230402

Sustained acoustic medicine treatment of discogenic ... RESULTS: SAM treatment significantly reduced chronic lower back pain from baseline relative to placebo treatment ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11492000/

Sustained acoustic medicine treatment of discogenic chronic ... Daily, home-use SAM treatment significantly improves the clinical symptoms of chronic lower back pain, improves physical mobility, and reduces daily medication ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT06611397

Discogen for Low Back Pain - Clinical Trial Finder 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8139719/

Effectiveness of Ultrasound Therapy on the Management ... This systematic review found ultrasound therapy could be an alternative treatment to reduce the intensity of pain in subjects with non-specific chronic LBP.

5. fusfoundation.org fusfoundation.org/posts/focused-ultrasound-for-back-pain-new-clinical-trial-begins-in-new-york/

Focused Ultrasound for Back Pain: New Clinical Trial ... This study is the first to test Discogen's DiscRx™ system, which uses low-intensity, pulsed focused ultrasound to promote the repair of early- ...

6. spine.org spine.org/portals/0/assets/downloads/researchclinicalcare/guidelines/lowbackpain.pdf

Diagnosis and Treatment of Low Back Pain Recommendations were developed based on a specific definition, inclusion/exclusion criteria, and the resulting literature which excluded conditions.