Dorsal Root Ganglion Stimulation for Knee Arthritis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kenneth B Chapman

Must not be taking: Opioids

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Dorsal root ganglion stimulation (DRG-S) may be able to treat mechanical pain caused by tissue injury or damage such as trauma or arthritis in addition to pain caused by nerve dysfunction or injury. The purpose of this study is to determine if dorsal root ganglion stimulation (DRG-S) can effectively treat arthritic pain of the knee.

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 data supports the effectiveness of the treatment Dorsal Root Ganglion Stimulation for knee arthritis?

Dorsal Root Ganglion Stimulation has been shown to provide pain relief in various chronic pain conditions, including complex regional pain syndrome (CRPS) of the knee, which is similar to knee arthritis in terms of pain management. Studies have indicated that patients with CRPS confined to the knee prefer DRG stimulation over other methods, suggesting its potential effectiveness for knee arthritis as well. ^{1 2 3 4 5}

How is dorsal root ganglion stimulation different from other treatments for knee arthritis?

Dorsal root ganglion stimulation (DRG-S) is unique because it targets specific nerves near the spine to relieve pain, unlike other treatments that might focus on the knee itself. This method is particularly promising for conditions like complex regional pain syndrome (CRPS) where other therapies often fail. ^{1 2 3 5 6}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Dorsal Root Ganglion Stimulation (Neurostimulation)

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.

Participant Groups

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

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

Findings from Research

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]

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]

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 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]

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]

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]

References

1. United States 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. [2022]

2. United States 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. [2022]

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

Dorsal Root Ganglion Stimulation for Lower Extremity Neuropathic Pain Syndromes: An Evidence-Based Literature Review. [2023]

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

Evaluating Dorsal Root Ganglion Stimulation in a Prospective Dutch Cohort. [2022]

5. United States 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. [2022]

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

Dorsal root ganglion stimulator for avascular necrosis of the hip. [2020]