Dorsal Root Ganglion Stimulation for Knee Arthritis

Overseen By Tariq a Yousef, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kenneth B Chapman

Must not be taking: Opioids

Disqualifiers: Non-English, Pregnancy, BMI >45, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether dorsal root ganglion stimulation (DRG-S) can reduce knee pain caused by arthritis. DRG-S applies mild electrical signals to specific nerves to ease pain. The trial includes two groups: individuals with knee arthritis who haven't had surgery and those who have undergone knee surgery but still experience pain. Ideal participants have experienced chronic knee pain for at least a year, affecting their daily activities, and have not found success with other treatments. As an unphased trial, this study provides a unique opportunity to contribute to understanding new pain relief methods for knee arthritis.

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 participants should have tried and failed at least two different classes of pain medications before joining, so you might need to continue with your current treatment plan.

What prior data suggests that dorsal root ganglion stimulation is safe for treating knee arthritis?

Research has shown that stimulating a specific group of nerves, called the dorsal root ganglion (DRG), is generally well-tolerated. Studies have found that this method can effectively treat persistent chronic knee pain. For example, one study reported a significant drop in pain levels, with many patients experiencing noticeable relief. Another study found that DRG stimulation might help with both joint and nerve-related pain. While more detailed research is needed to confirm these findings, current data suggests the treatment is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for knee arthritis focus on medications like NSAIDs or procedures such as joint injections and surgery to manage pain and inflammation. However, dorsal root ganglion stimulation (DRG-S) stands out because it directly targets the nerve clusters responsible for transmitting pain signals from the knee. By modulating these signals, DRG-S can provide pain relief without the need for systemic medications or invasive surgeries. Researchers are excited about this approach because it offers a non-invasive alternative that could lead to better pain management with fewer side effects, especially for patients with a history of knee surgery or those who haven't undergone surgical interventions.

What evidence suggests that dorsal root ganglion stimulation might be an effective treatment for knee arthritis?

Research has shown that stimulating the dorsal root ganglion (DRG-S) can greatly reduce pain for people with knee osteoarthritis, a type of arthritis affecting the joints. Animal studies found that DRG-S lessened pain-related behaviors, suggesting it might work similarly in humans. Various studies report that many people experience significant pain relief, especially in areas like the foot and groin. DRG-S has also proven more successful than traditional methods like spinal cord stimulation. This trial will evaluate DRG-S in two separate treatment arms: one for knee osteoarthritis patients with no history of knee surgery and another for those with a history of surgical repair of the knee. These findings suggest that DRG-S could be an effective treatment for knee arthritis pain. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 21 with chronic knee pain due to arthritis, who have tried other treatments like physical therapy and medications without relief. It's for those not suitable or willing to undergo knee surgery, including patients with a history of surgical repair. Participants must have moderate to severe arthritis confirmed by recent scans and significant pain despite past interventions.

Inclusion Criteria

My knee arthritis is confirmed as mild, moderate, or severe by a recent scan.

I have had knee pain for over a year that affects my daily activities.

I am 21 years old or older.

Exclusion Criteria

I have a collagen disease like lupus or scleroderma.

I am expecting to have surgery during the trial period.

I do not have any health or social conditions that prevent DRG stimulation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Trial Stimulation

Participants undergo a one-week trial of dorsal root ganglion stimulation to assess response

1 week

1 visit (in-person)

Implantation and Treatment

Participants who respond positively are implanted with a permanent stimulation device and receive ongoing treatment

12 months

5 visits (in-person) at 1, 3, 6, 9, and 12 months post-implant

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Dorsal Root Ganglion Stimulation

Trial Overview The study tests if Dorsal Root Ganglion Stimulation (DRG-S) can effectively relieve arthritic knee pain. DRG-S targets specific nerves affected by tissue damage or dysfunction from conditions like trauma or osteoarthritis, aiming to reduce mechanical pain in the knee.

How Is the Trial Designed?

Group I: Surgically Repaired Knee Osteoarthritis Experimental Treatment 1 Intervention

DRG-S for knee osteoarthritis patients with history of surgical repair of the knee

Group II: Non-operated Knee Osteoarthritis Experimental Treatment 1 Intervention

DRG-S for knee osteoarthritis patients with no history of knee surgery

Dorsal Root Ganglion Stimulation is already approved in United States for the following indications:

Approved in United States as Dorsal Root Ganglion Stimulation for:

• Complex Regional Pain Syndrome (CRPS) types I and II
• Chronic intractable pain of the lower limbs

Who Is Running the Clinical Trial?

Kenneth B Chapman

Lead Sponsor

Trials

1

Recruited

30+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Published Research Related to This Trial

In a study involving 12 patients with complex regional pain syndrome (CRPS) confined to the knee, 83.3% preferred dorsal root ganglion (DRG) stimulation over dorsal column (DC) stimulation after a 16-day trial period, indicating a strong preference for DRG stimulation.

This is the first study to directly compare DC and DRG neurostimulation methods for knee CRPS, suggesting that DRG stimulation may offer a more effective treatment option for patients who are often resistant to therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dorsal Column Stimulation vs. Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome Confined to the Knee: Patients' Preference Following the Trial Period. van Bussel, CM., Stronks, DL., Huygen, FJPM.[2022]

In a study of 66 participants with chronic pain, dorsal root ganglion (DRG) stimulation led to a significant reduction in pain levels, with average pain ratings dropping from 8.0 cm to 4.1 cm after 12 months, and 49% of subjects experiencing at least a 50% reduction in pain.

The treatment also improved functional capacity, mood, and quality of life, with a high success rate of permanent implants (86.2%) and a low incidence of complications such as infections or lead migrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Dorsal Root Ganglion Stimulation in a Prospective Dutch Cohort. Huygen, FJPM., Liem, L., Nijhuis, H., et al.[2022]

Dorsal root ganglion (DRG) stimulation was successfully used in a 48-year-old woman with complex regional pain syndrome (CRPS) type I of the knee, leading to significant pain relief after implantation of a pulse generator.

Three months post-implantation, the patient reported a dramatic reduction in pain, with a numeric rating scale score of 1-2, indicating that DRG stimulation could be an effective treatment for intractable CRPS of the knee.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful treatment of intractable complex regional pain syndrome type I of the knee with dorsal root ganglion stimulation: a case report. van Bussel, CM., Stronks, DL., Huygen, FJ.[2022]

Dorsal root ganglion stimulation is an emerging treatment for chronic pain management, particularly effective for conditions like complex regional pain syndrome.

In a case study of a 24-year-old woman with severe hip pain from avascular necrosis, the implantation of a dorsal root ganglion stimulator resulted in significant pain relief after other treatments had failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dorsal root ganglion stimulator for avascular necrosis of the hip. Victor, S., Burnett, C., Lange, R., et al.[2020]

Dorsal root ganglion stimulation (DRG-S) is an FDA-approved therapy for complex regional pain syndrome (CRPS) and shows promise for treating various lower extremity neuropathic pain conditions, although current evidence is limited to one randomized controlled trial and 39 observational studies.

The primary outcome of DRG-S treatment is a reduction in pain intensity, but more rigorous randomized controlled trials with consistent participant characteristics are needed to strengthen the evidence for its efficacy across different types and locations of neuropathies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dorsal Root Ganglion Stimulation for Lower Extremity Neuropathic Pain Syndromes: An Evidence-Based Literature Review. D'Souza, RS., Kubrova, E., Her, YF., et al.[2023]

In a study of 93 patients receiving dorsal root ganglion (DRG) stimulation for pain relief, those with a history of chronic opioid use were less likely to achieve significant pain relief (≥50% or ≥80%) at multiple follow-up points (1 month, 3 months, and 12 months).

The findings suggest that prior chronic opioid use may negatively impact the effectiveness of DRG stimulation, indicating that patient history should be considered when predicting treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Patient Characteristics on Clinical Outcomes More Than 12 Months Following Dorsal Root Ganglion Stimulation Implantation: A Retrospective Review. Hagedorn, JM., McArdle, I., D'Souza, RS., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1094715924010663

P116 DORSAL ROOT GANGLION STIMULATION ... Supported in a rodent model of osteoarthritis (OA) of the knee, where DRG-S alleviated pain-related behavior in rats. This investigator-sponsored, single-site, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7079258/

Effectiveness and Safety of Dorsal Root Ganglion ... Our pooled analysis showed a pain score for primary affected region ranging from 1.7 (groin) to 3.0 (buttocks) and responder rates of 80% for foot and groin, ...

3. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(23)00598-6/pdf

ID: 203311 Dorsal Root Ganglion Stimulation Outcomes for ... In addition, DRG-S has demonstrated analgesic effectiveness in osteoarthritic preclinical rat pain models of the knee with peripheral pathologic origins. This ...

4. withpower.com withpower.com/trial/phase-ganglion-cysts-10-2021-03af4

Dorsal Root Ganglion Stimulation for Knee Arthritis The primary outcome of DRG-S treatment is a reduction in pain intensity, but more rigorous randomized controlled trials with consistent participant ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/papr.13180

Dorsal root ganglion stimulation for the treatment of joint ... Dorsal root ganglion stimulation (DRG-S) has recently emerged as a novel therapy in neuromodulation that demonstrated a higher rate of success than spinal cord ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875020316235

Dorsal Root Ganglion Stimulation for the Treatment of ... Dorsal root ganglion stimulation is an extremely efficacious means of treating otherwise refractory chronic knee pain.