New nerve zap treatment could ease arthritic knee pain
NCT ID NCT05103527
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a treatment called dorsal root ganglion stimulation (DRG-S) can reduce chronic knee pain caused by osteoarthritis. About 30 adults with long-term knee pain who have not had surgery or are not good candidates for it will receive a device that sends mild electrical pulses to nerves near the spine. The main goal is to see if at least half of participants report a 50% or greater drop in pain after 3 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Spine and Pain Institute of New York
New York, New York, 10305, United States
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Other studies related to the condition(s) this trial covers.
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