Dorsal Root Ganglion Stimulation for the Treatment of Arthritic Knee Pain

Description

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.

Conditions

Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis, Knee Arthropathy

Study Overview

Study Details

Study overview

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.

Dorsal Root Ganglion Stimulation Outcomes for the Treatment of Mechanical Knee Pain Among Patients With Osteoarthritis of the Surgical and Non-surgical Knee

Dorsal Root Ganglion Stimulation for the Treatment of Arthritic Knee Pain

Condition
Knee Osteoarthritis
Intervention / Treatment

-

Contacts and Locations

New York

The Spine and Pain Institute of New York, New York, New York, United States, 10305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kenneth B Chapman,

Study Record Dates

2026-03-31