Dorsal Root Ganglion Stimulation for the Treatment of Arthritic Knee Pain (NCT05103527) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Dorsal Root Ganglion Stimulation for the Treatment of Arthritic Knee Pain
United States30 participantsStarted 2022-01-01
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …