Dorsal Root Ganglion Stimulation for the Treatment of Arthritic Knee Pain

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05103527
• Other study ID #: DRG-S for Knee OA
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2022
• Source: Spine and Pain Institute of New York
• Contact: Kenneth B Chapman, MD
• Phone: 7186673577
• Email: chapmanken[@]spinepainny.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The purpose of this study is to determine if dorsal root ganglion stimulation (DRG-S) can effectively treat arthritic pain of the knee.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Ganglion Cysts
• Knee Arthritis
• Knee Arthropathy
• Knee Osteoarthritis
• Knee Pain Chronic
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Dorsal Root Ganglion Stimulation
Stimulation at L2, L3, L4 and S1 spinal levels

Locations

Country	Name	City	State
United States	The Spine and Pain Institute of New York	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Kenneth B Chapman	Abbott

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	All complications of DRG-S trial, implant, and stimulation therapy will be reported	Up to 12 months post-implant
Primary	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	3 months post-implant
Secondary	VAS pain scores	Patient's pain score using standard 10cm pain scale that represents a continuum between "no pain" and "worst pain."	1-, 3-, 6-, 9-, and 12 months post-implant
Secondary	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.	1-, 3-, 6-, 9-, and 12 months post-implant
Secondary	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	1-, 3-, 6-, 9-, and 12 months post-implant
Secondary	Short Form 36 Mental Component Summary (SF-36 MCS)	At each study visit, subjects will complete SF-36 MCS survey which assesses mental health	1-, 3-, 6-, 9-, and 12 months post-implant
Secondary	Pain Disability Index (PDI)	At each study visit, subjects will complete PDI survey which assesses pain-related disability	1-, 3-, 6-, 9-, and 12 months post-implant
Secondary	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	1-, 3-, 6-, 9-, and 12 months post-implant
Secondary	Medication Dosage	Patient's dose of narcotic analgesics measured in morphine milligram equivalents (MME) and non-narcotic analgesics and dosages	1-, 3-, 6-, 9-, and 12 months post-implant
Secondary	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.	1-, 3-, 6-, 9-, and 12 months post-implant
Secondary	Knee Range of Motion (ROM)	Video recordings of motor task exams will be used to measure ROM of the index knee	1-, 3-, 6-, 9-, and 12 months post-implant
Secondary	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)	3-, 6-, and 12-months post-implant
Secondary	Kellgren-Lawrence System for Classification of Osteoarthritis	Radiologic classification of subject's knee x-ray to grade progression/severity of osteoarthritis	6- and 12-months post-implant
Secondary	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	1-, 6-, 9-, and 12-months post-implant