PerQdisc for Low Back Pain

Recruiting at 2 trial locations

Overseen By Andy Murillo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spinal Stabilization Technologies

Must not be taking: Opioids, Anticoagulants

Disqualifiers: Diabetes, Obesity, Osteoporosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

5 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on opioid medication, you must not exceed 60 MME (morphine milligram equivalent) per day or have any changes in your opioid prescription within 60 days of surgery.

How is the PerQdisc treatment different from other treatments for low back pain?

PerQdisc is unique because it involves the use of a hydrogel that is administered directly into the disc in the spine, which is different from typical treatments like oral medications or surgery. This approach aims to address the underlying disc issues by providing mechanical support and potentially reducing inflammation, offering a minimally invasive alternative for patients who do not respond to conventional therapies. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a traditional feasibility study (TFS) study to evaluate the safety and effectiveness of the PerQdisc. The study is prospective, multicenter, and open label. After a screening period, qualified participants will be enrolled and treated with the PerQdisc. Patients will not be blinded to their treatment. Participants will then complete the safety follow-up period.

Eligibility Criteria

This trial is for individuals experiencing back pain, specifically discogenic low back pain. Participants should be suitable candidates for the PerQdisc treatment based on a screening process. Details about specific inclusion and exclusion criteria are not provided, but typically these would outline health conditions or factors that qualify or disqualify someone from participating.

Inclusion Criteria

My back pain hasn't improved after 6 months of standard treatment.

Subject has read and understands the IRB approved informed consent document prior to signing and dating the document

I am a suitable candidate for PerQdisc surgery.

Exclusion Criteria

Subject has a spinal cord stimulator

I am on long-term blood thinner medication.

I have had spinal fusion surgery in my back.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with the PerQdisc device to evaluate its safety and effectiveness

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• PerQdisc

Trial Overview The trial is testing the safety and effectiveness of a device called PerQdisc in treating discogenic low back pain. It's a prospective study, meaning it follows patients over time, conducted across multiple centers, and open label so participants know they're receiving the PerQdisc treatment.

Participant Groups

Group I: PerQdisc Experimental Treatment 1 Intervention

The PerQdisc device is the first in a new category of contained in-situ filled and then cured lumbar spinal implant. The PerQdisc is intended to replace the nucleus pulposus in a single lumbar disc level, preserve motion and alleviate pain. The PerQdisc is a silicone membrane (barrier membrane) configured to be filled with a room temperature vulcanizing silicone (RTVS) that will cure within minutes, resulting in a final shape that conforms to the nucleus space created by the surgical removal of the diseased or damaged nucleus pulposus.

Who Is Running the Clinical Trial?

Spinal Stabilization Technologies

Lead Sponsor

Trials

6

Recruited

220+

Findings from Research

In a study of 29 patients with degenerative disc disease who did not respond to conservative treatments, percutaneous intradiscal GelStix administration significantly reduced pain levels, with mean visual analogue scale (VAS) scores dropping from 7.14 to 2.48 over 12 months (P < 0.001).

Patients also experienced improved functionality, as indicated by a decrease in the Oswestry Disability Index (ODI) scores from 28.14 to 17.35, and 86.2% reported satisfaction with the procedure at the 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical results of intradiscal hydrogel administration (GelStix) in lumbar degenerative disc disease Ceylan, A., Aşik, I., Özgencil, GE., et al.[2020]

Conservative therapy, including non-steroidal anti-inflammatory drugs (NSAIDs) like piroxicam, indomethacin, and diclofenac, is effective for treating acute low back pain, with studies showing these medications have nearly identical efficacy.

Intramuscular piroxicam (40 mg for two days, then 20 mg) provided effective pain relief and was well-tolerated compared to higher doses of ketoprofen and diclofenac, suggesting it may be a preferable option for managing low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low back pain. Simon, L.[2013]

Most monotherapies for chronic low back pain, such as analgesics and physiotherapy, have limited effectiveness, while multidisciplinary therapy focusing on intensive exercises shows modest improvements in physical function and pain relief.

Specific diagnostic techniques like joint blocks can identify pain sources in a significant number of patients, and treatments like radiofrequency neurotomy can effectively relieve zygapophysial joint pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of chronic low back pain. Bogduk, N.[2022]

Intradiscal electrothermal therapy (IDET) is a promising minimally invasive treatment for internal disc disruption (IDD) in patients with low back pain, offering a potential alternative to traditional conservative or surgical options.

The effectiveness of IDET appears to be significant in carefully selected patients, but further research with long-term follow-up is needed to fully establish its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intradiscal electrothermal therapy (IDET)]. Münnich, U., Kreckel, V., Koy, T., et al.[2016]

In a study involving 20 patients with chronic low back pain due to degenerative disc disease, the use of intradiscal hydrogel showed significant effectiveness, reducing pain scores from a median of 7 to 1 and improving disability scores significantly over a follow-up period of 6 months.

The treatment was deemed safe, with only 5 serious adverse events reported, 4 of which were associated with the treatment, but no persistently symptomatic adverse effects were noted, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrogel Augmentation of the Lumbar Intervertebral Disc: An Early Feasibility Study of a Treatment for Discogenic Low Back Pain. Beall, DP., Amirdelfan, K., Nunley, PD., et al.[2023]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Clinical results of intradiscal hydrogel administration (GelStix) in lumbar degenerative disc disease [2020]

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

Low back pain. [2013]

3. Australia pubmed.ncbi.nlm.nih.gov

Management of chronic low back pain. [2022]

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

[Intradiscal electrothermal therapy (IDET)]. [2016]

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

Hydrogel Augmentation of the Lumbar Intervertebral Disc: An Early Feasibility Study of a Treatment for Discogenic Low Back Pain. [2023]