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Knee OsteoarthritisNCT05103527

Dorsal Root Ganglion Stimulation for the Treatment of Arthritic Knee Pain

A study testing Dorsal Root Ganglion Stimulation in people with Knee Osteoarthritis and Knee Pain Chronic, run by Kenneth B Chapman at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Dorsal Root Ganglion Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Jan 2022to May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Spine and Pain Institute of New York

    New York, New York, 10305

Other trials in United States

About this study

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

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.

Read the detailed description

Dorsal root ganglion stimulation (DRG-S) is a novel form of neuromodulation used to treat chronic neuropathic pain of the groin and lower extremities related to complex regional pain syndrome type I or II (causalgia). DRG-S has shown promise in treating traditionally mixed neuropathic and mechanical pain syndromes such as axial low back pain, suggesting DRG-S may be able to treat mechanical pain in addition to neuropathic pain. Additionally, in a rodent model of osteoarthritis of the knee, DRG-S alleviated pain related behavior in rats.

This open label feasibility study seeks to evaluate if dorsal root ganglion stimulation with Abbott's Proclaim Dorsal Root Ganglion Neurostimulator System can effectively treat osteoarthritis of the knee. Patients with either osteoarthritis of the non-operated knee or osteoarthritis of the surgically repaired knee will be trialed for one week with dorsal root ganglion stimulation to determine if they positively respond with 50% or greater pain relief. For those patients that have a successful trial, they will be implanted with a permanent stimulation device system and followed for one year post implant to measure knee pain, function and disability, and other related outcomes with sustained DRG-S therapy.

Patients will be seen and evaluated prior to DRG-S trial, and for those that receive permanent implants, re-evaluated at 1, 3, 6, 9 and 12 months after implant.

Being tested
Dorsal Root Ganglion Stimulation
Keywords
Dorsal Root Ganglion Stimulation, knee pain, knee arthritis, osteoarthritis
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dorsal Root Ganglion StimulationDevice

    Stimulation at L2, L3, L4 and S1 spinal levels

Study groups in NCT05103527
Study groupRoleWhat they receive
Non-operated Knee OsteoarthritisExperimentalDRG-S for knee osteoarthritis patients with no history of knee surgery
Receives: Device: Dorsal Root Ganglion Stimulation
Surgically Repaired Knee OsteoarthritisExperimentalDRG-S for knee osteoarthritis patients with history of surgical repair of the knee
Receives: Device: Dorsal Root Ganglion Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment success rate at 3 months

    Percent of DRG-S implanted patients that successfully respond to stimulation therapy as defined by >=50% reduction in reported pain score from baseline

    Measured: 3 months post-implant

Secondary outcomes (12)

  1. VAS pain scores

    Patient's pain score using standard 10cm pain scale that represents a continuum between "no pain" and "worst pain."

    Measured: 1-, 3-, 6-, 9-, and 12 months post-implant

  2. Western Ontario and McMaster Universities Arthritis Index (WOMAC) for knee pain patients

    At each study visit, subjects will complete WOMAC survey which assesses pain, stiffness, and function in patients with OA of the knee.

    Measured: 1-, 3-, 6-, 9-, and 12 months post-implant

  3. European Quality of Life 5 Dimension (EQ-5D)

    At each study visit, subjects will complete EQ-5D survey which assesses health-related quality of life

    Measured: 1-, 3-, 6-, 9-, and 12 months post-implant

  4. Short Form 36 Mental Component Summary (SF-36 MCS)

    At each study visit, subjects will complete SF-36 MCS survey which assesses mental health

    Measured: 1-, 3-, 6-, 9-, and 12 months post-implant

  5. Pain Disability Index (PDI)

    At each study visit, subjects will complete PDI survey which assesses pain-related disability

    Measured: 1-, 3-, 6-, 9-, and 12 months post-implant

  6. Patient Global Impression of Change (PGIC)

    At each study visit, subjects will complete PDI survey which assesses patient's belief about the efficacy of treatment

    Measured: 1-, 3-, 6-, 9-, and 12 months post-implant

  7. Medication Dosage

    Patient's dose of narcotic analgesics measured in morphine milligram equivalents (MME) and non-narcotic analgesics and dosages

    Measured: 1-, 3-, 6-, 9-, and 12 months post-implant

  8. Timed Up and Go (TUG)

    Video recordings of motor task exams will be used to measure TUG, a performance-based measure of functional mobility which measures the time for subject to rise from a chair, walk three meters, turn around, return to the chair, and sit down.

    Measured: 1-, 3-, 6-, 9-, and 12 months post-implant

  9. Knee Range of Motion (ROM)

    Video recordings of motor task exams will be used to measure ROM of the index knee

    Measured: 1-, 3-, 6-, 9-, and 12 months post-implant

  10. Serum concentrations of molecular biomarkers

    Serum concentrations of molecular biomarkers related to knee OA including but not limited to C-telopeptide of crosslinked collagen type I and type II (CTX-I and CTX-II)

    Measured: 3-, 6-, and 12-months post-implant

  11. Kellgren-Lawrence System for Classification of Osteoarthritis

    Radiologic classification of subject's knee x-ray to grade progression/severity of osteoarthritis

    Measured: 6- and 12-months post-implant

  12. Treatment success rate at other post-implant timepoints

    Percent of DRG-S implanted patients that successfully respond to stimulation therapy as defined by >=50% reduction in reported pain score from baseline

    Measured: 1-, 6-, 9-, and 12-months post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2021
  2. Study start1 Jan 2022
  3. Primary completion14 Aug 2025
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Subjects will undergo one week DRG-S trial, and for those that respond as defined by 50% or greater pain relief, proceed to DRG-S permanent device system implant
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05103527
Sponsor's protocol ID
DRG-S for Knee OA
Status last verified
Oct 2025
First submitted
23 Sep 2021
Last updated
21 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Yu G, Segel I, Zhang Z, Hogan QH, Pan B. Dorsal Root Ganglion Stimulation Alleviates Pain-related Behaviors in Rats with Nerve Injury and Osteoarthritis. Anesthesiology. 2020 Aug;133(2):408-425. doi: 10.1097/ALN.0000000000003348.

    PubMed 32433276

  • Bjerre-Bastos JJ, Bay-Jensen A-C, Karsdal MA, Byrjalsen I, Andersen JR, Riis BJ, et al. Biomarkers of bone and cartilage turnover CTX-I and CTX-II predict total joint replacements in osteoarthritis. Osteoarthr Cartil [Internet]. 2019;27(2019):S31-2. Available from: https://doi.org/10.1016/j.joca.2019.02.046

  • Convill JG, Tawy GF, Freemont AJ, Biant LC. Clinically Relevant Molecular Biomarkers for Use in Human Knee Osteoarthritis: A Systematic Review. Cartilage. 2021 Dec;13(1_suppl):1511S-1531S. doi: 10.1177/1947603520941239. Epub 2020 Jul 17.

    PubMed 32680434

  • Adhikary SD, Liu WM, Memtsoudis SG, Davis CM 3rd, Liu J. Body Mass Index More Than 45 kg/m(2) as a Cutoff Point Is Associated With Dramatically Increased Postoperative Complications in Total Knee Arthroplasty and Total Hip Arthroplasty. J Arthroplasty. 2016 Apr;31(4):749-53. doi: 10.1016/j.arth.2015.10.042. Epub 2015 Nov 10.

    PubMed 26652477

  • van Bussel CM, Stronks DL, Huygen FJPM. Dorsal Column Stimulation vs. Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome Confined to the Knee: Patients' Preference Following the Trial Period. Pain Pract. 2018 Jan;18(1):87-93. doi: 10.1111/papr.12573. Epub 2017 May 4.

    PubMed 28334499

  • Kallewaard JW, Edelbroek C, Terheggen M, Raza A, Geurts JW. A Prospective Study of Dorsal Root Ganglion Stimulation for Non-Operated Discogenic Low Back Pain. Neuromodulation. 2020 Feb;23(2):196-202. doi: 10.1111/ner.12937. Epub 2019 Mar 1.

    PubMed 30821901

  • Huygen F, Liem L, Cusack W, Kramer J. Stimulation of the L2-L3 Dorsal Root Ganglia Induces Effective Pain Relief in the Low Back. Pain Pract. 2018 Feb;18(2):205-213. doi: 10.1111/papr.12591. Epub 2017 Dec 6.

    PubMed 28486758

Questions about this trial

What is this clinical trial studying?

A study testing Dorsal Root Ganglion Stimulation in people with Knee Osteoarthritis and Knee Pain Chronic, run by Kenneth B Chapman at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment success rate at 3 months (time frame: 3 months post-implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05103527, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.

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