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Dorsal Root Ganglion Stimulation for the Treatment of Arthritic Knee Pain

Active, not recruitingNot applicableNCT05103527
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Dorsal Root Ganglion Stimulation Outcomes for the Treatment of Mechanical Knee Pain Among Patients With Osteoarthritis of the Surgical and Non-surgical Knee
Interventions
  • Device: Dorsal Root Ganglion Stimulation
Sponsor
Kenneth B Chapman
Collaborators
Abbott
Organization
Spine and Pain Institute of New York
Start date
2022-01-01
Primary completion
2025-08-14
Sex
All
Age range
from 21 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05103527