Dorsal root ganglion stimulation for knee arthritis pain relief
Dorsal Root Ganglion Stimulation Outcomes for the Treatment of Mechanical Knee Pain Among Patients With Osteoarthritis of the Surgical and Non-surgical Knee
This study is testing if a new type of nerve stimulation can help people with knee arthritis pain feel at least 50% better after a week.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Spine and Pain Institute of New York Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05103527 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of dorsal root ganglion stimulation (DRG-S) in treating chronic knee pain associated with osteoarthritis. It aims to assess whether patients can achieve at least 50% pain relief after a one-week trial of DRG-S using Abbott's Proclaim Neurostimulator System. Those who respond positively will receive a permanent device and will be monitored for one year to evaluate pain, function, and disability outcomes. The study includes patients with either non-operated or surgically repaired knees who have not found relief from conservative treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with chronic knee pain for at least one year that affects their daily activities.
Not a fit: Patients who have not experienced knee pain for at least one year or those who have not tried conservative treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide significant pain relief and improved function for patients suffering from knee osteoarthritis.
How similar studies have performed: While DRG-S has shown promise in treating mixed pain syndromes, this specific application for knee osteoarthritis is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 21 years old * Able to provide informed consent * Primary complaint of chronic knee pain for at least 1 year that interferes with functional activities * Current pain score on visual analog scale (VAS) intensity ≥60 mm * One of two groups: 1) Non-operated knee pain patients who want to pursue alternative therapies and delay surgery or are not candidates for knee arthroplasty based on age, frailty, non-operable condition, or poor outcome with other side arthroplasty, or 2) Post traumatic knee pain patients with history of surgical repair (such as meniscal or ligament repair). * Radiologic confirmation (x-ray/MRI/CT) of Kellgren-Lawrence OA grade of 2 (mild) or 3 (moderate) or 4 (severe) noted within 6 months for the index knee * Continued pain in the target knee despite at least 3 months of conservative treatments with documented failure of physical therapy and standard conservative therapy, including trials of at least two different classes of analgesic medication * Failure of one or more prior interventional pain procedures such intraarticular corticosteroid or hyaluronidase knee injections, cooled radiofrequency ablation therapy, or regenerative medicine or prior surgery of the knee Exclusion Criteria: * Non-English speaking * Douleur neuropathique 4 (DN4) score ≥4 * Receiving opioid analgesic medication at a dose of ≥90 mg oral morphine equivalents * Workers' compensation or no-fault insurance * Signs or symptoms of active infection in the index knee joint * Pregnancy * BMI \>45 * Presence of any contraindication for DRG stimulation, including neurological, medical, psychiatric, or social conditions. * Widespread pain conditions like fibromyalgia * Autoimmune/Inflammatory arthritic conditions such as Rheumatoid and psoriatic arthritis and other allied disorders (sjogren, felty, inflammatory bowl disease etc) * Collagen diseases (systemic lupus erythematosus, Scleroderma, etc) * Infectious arthritis * Evidence of prespecified joint safety conditions (eg, rapidly progressive OA, subchondral insufficiency fracture, osteonecrosis, pathologic fracture) in the index knee on screening radiographs * Scheduled for or anticipating any surgery during the trial period
Where this trial is running
New York, New York
- The Spine and Pain Institute of New York — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Kenneth B Chapman, MD
- Email: chapmanken@spinepainny.com
- Phone: 7186673577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.