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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Discogen Low pulsed ultrasound treatment for low back pain?

Research suggests that low intensity pulsed ultrasound (LIPUS) can help heal injured or degenerated intervertebral discs, which are often a source of low back pain. LIPUS has been shown to improve healing in other conditions, like bone fractures, and studies indicate it may reduce inflammation and promote tissue repair in disc cells. ^{1 2 3 4 5}

Is Discogen (low-intensity pulsed ultrasound) safe for humans?

Low-intensity pulsed ultrasound (LIPUS) has been shown to be a safe and non-invasive treatment option in various studies, including those for bone healing and disc degeneration. It has been used effectively in clinical trials for bone repair, with a good safety profile and no significant adverse effects reported. ^{2 5 6 7 8}

How does the Discogen Low pulsed ultrasound treatment differ from other treatments for low back pain?

Discogen Low pulsed ultrasound treatment is unique because it uses low-intensity pulsed ultrasound (LIPUS) to non-invasively target and heal injured or degenerated intervertebral disc tissues, potentially offering a precise and localized treatment option for discogenic low back pain without the need for surgery. ^{2 9 10 11 12}

Research Team

Clark Smith, MD, PhD

Principal Investigator

Columbia University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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) 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]

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) 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]

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]

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]

References

1. England 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. [2020]

2. England pubmed.ncbi.nlm.nih.gov

In silico feasibility assessment of extracorporeal delivery of low-intensity pulsed ultrasound to intervertebral discs within the lumbar spine. [2022]

3. Belgium pubmed.ncbi.nlm.nih.gov

A randomized, single blind placebo controlled clinical trial on the effect of continuous ultrasound on low back pain. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Pain intensity and power densities of therapeutic ultrasound--a serial, comparative pilot study in patients with low back pain]. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Low intensity pulsed ultrasound (LIPUS) for the treatment of intervertebral disc degeneration. [2020]

6. Switzerland 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. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Low-intensity pulsed ultrasound for the treatment of bone delayed union or nonunion: a review. [2009]

8. China 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]. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Intradiscal Pulsed Radiofrequency Application Duration Effect on Lumbar Discogenic Low Back Pain. [2021]

10. United States 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. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Thermal Annular Procedures in Treating Discogenic Low Back Pain. [2019]

12. Japan 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. [2022]