Clinical trial NCT05103527: Dorsal Root Ganglion Stimulation for the Treatment of Arthritic Knee Pain
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Knee Pain Chronic
Knee Arthritis
Knee Arthropathy
Keywords: Dorsal Root Ganglion Stimulation
knee pain
knee arthritis
osteoarthritis
Lead sponsor: Spine and Pain Institute of New York
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2021-11-02
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment success rate at 3 months
timeFrame: 3 months post-implant
Secondary outcomes:
measure: VAS pain scores
timeFrame: 1-, 3-, 6-, 9-, and 12 months post-implant
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) for knee pain patients
timeFrame: 1-, 3-, 6-, 9-, and 12 months post-implant
measure: European Quality of Life 5 Dimension (EQ-5D)
timeFrame: 1-, 3-, 6-, 9-, and 12 months post-implant
measure: Short Form 36 Mental Component Summary (SF-36 MCS)
timeFrame: 1-, 3-, 6-, 9-, and 12 months post-implant
measure: Pain Disability Index (PDI)
timeFrame: 1-, 3-, 6-, 9-, and 12 months post-implant
measure: Patient Global Impression of Change (PGIC)
timeFrame: 1-, 3-, 6-, 9-, and 12 months post-implant
measure: Medication Dosage
timeFrame: 1-, 3-, 6-, 9-, and 12 months post-implant
measure: Timed Up and Go (TUG)
timeFrame: 1-, 3-, 6-, 9-, and 12 months post-implant
measure: Knee Range of Motion (ROM)
timeFrame: 1-, 3-, 6-, 9-, and 12 months post-implant
measure: Serum concentrations of molecular biomarkers
timeFrame: 3-, 6-, and 12-months post-implant
measure: Kellgren-Lawrence System for Classification of Osteoarthritis
timeFrame: 6- and 12-months post-implant
measure: Treatment success rate at other post-implant timepoints
timeFrame: 1-, 6-, 9-, and 12-months post-implant
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 12 months post-implant
Locations:
city: New York
country: United States
facility: The Spine and Pain Institute of New York
state: New York
Study officials:
References:
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.