Dorsal Root Ganglion Stimulation for the Treatment of Arthritic Knee Pain

Launched by KENNETH B CHAPMAN · Nov 1, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called dorsal root ganglion stimulation (DRG-S) to see if it can help relieve knee pain caused by arthritis. The researchers want to find out if this method can effectively reduce pain in people who have been suffering from chronic knee pain for at least a year and who have not found relief from other treatments. The study is open to adults aged 21 and older, including those who are considering alternatives to surgery or who have had past knee surgeries but still experience pain.

To take part in the trial, participants must have a significant level of knee pain and have tried various treatments without success. They should also have confirmed arthritis in their knee based on recent imaging tests. While the trial is still recruiting participants, it's important to note that certain conditions, such as active infections, severe obesity, or other specific health issues may prevent someone from participating. Those who join can expect to receive DRG-S treatment and be closely monitored to assess its effects on their pain levels and overall function.

Gender

ALL

Eligibility 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