Dorsal Root Ganglion Stimulation for the Treatment of Arthritic Knee Pain

Sponsor

Kenneth B Chapman (Other)

Overall Status

Recruiting

CT.gov ID

NCT05103527

Collaborator

Abbott (Industry)

Enrollment

Location

Arms

28.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis Knee Pain Chronic Knee Arthritis Knee Arthropathy	Device: Dorsal Root Ganglion Stimulation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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 implantSubjects 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)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Non-operated Knee Osteoarthritis DRG-S for knee osteoarthritis patients with no history of knee surgery	Device: Dorsal Root Ganglion Stimulation Stimulation at L2, L3, L4 and S1 spinal levels
Experimental: Surgically Repaired Knee Osteoarthritis DRG-S for knee osteoarthritis patients with history of surgical repair of the knee	Device: Dorsal Root Ganglion Stimulation Stimulation at L2, L3, L4 and S1 spinal levels

Arm

Intervention/Treatment

Experimental: Non-operated Knee Osteoarthritis

DRG-S for knee osteoarthritis patients with no history of knee surgery

Device: Dorsal Root Ganglion Stimulation

Stimulation at L2, L3, L4 and S1 spinal levels

Experimental: Surgically Repaired Knee Osteoarthritis

DRG-S for knee osteoarthritis patients with history of surgical repair of the knee

Device: Dorsal Root Ganglion Stimulation

Stimulation at L2, L3, L4 and S1 spinal levels

Outcome Measures

Primary Outcome Measures

Treatment success rate at 3 months [3 months post-implant]
Percent of DRG-S implanted patients that successfully respond to stimulation therapy as defined by >=50% reduction in reported pain score from baseline

Secondary Outcome Measures

VAS pain scores [1-, 3-, 6-, 9-, and 12 months post-implant]
Patient's pain score using standard 10cm pain scale that represents a continuum between "no pain" and "worst pain."
Western Ontario and McMaster Universities Arthritis Index (WOMAC) for knee pain patients [1-, 3-, 6-, 9-, and 12 months post-implant]
At each study visit, subjects will complete WOMAC survey which assesses pain, stiffness, and function in patients with OA of the knee.
European Quality of Life 5 Dimension (EQ-5D) [1-, 3-, 6-, 9-, and 12 months post-implant]
At each study visit, subjects will complete EQ-5D survey which assesses health-related quality of life
Short Form 36 Mental Component Summary (SF-36 MCS) [1-, 3-, 6-, 9-, and 12 months post-implant]
At each study visit, subjects will complete SF-36 MCS survey which assesses mental health
Pain Disability Index (PDI) [1-, 3-, 6-, 9-, and 12 months post-implant]
At each study visit, subjects will complete PDI survey which assesses pain-related disability
Patient Global Impression of Change (PGIC) [1-, 3-, 6-, 9-, and 12 months post-implant]
At each study visit, subjects will complete PDI survey which assesses patient's belief about the efficacy of treatment
Medication Dosage [1-, 3-, 6-, 9-, and 12 months post-implant]
Patient's dose of narcotic analgesics measured in morphine milligram equivalents (MME) and non-narcotic analgesics and dosages
Timed Up and Go (TUG) [1-, 3-, 6-, 9-, and 12 months post-implant]
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.
Knee Range of Motion (ROM) [1-, 3-, 6-, 9-, and 12 months post-implant]
Video recordings of motor task exams will be used to measure ROM of the index knee
Serum concentrations of molecular biomarkers [3-, 6-, and 12-months post-implant]
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)
Kellgren-Lawrence System for Classification of Osteoarthritis [6- and 12-months post-implant]
Radiologic classification of subject's knee x-ray to grade progression/severity of osteoarthritis
Treatment success rate at other post-implant timepoints [1-, 6-, 9-, and 12-months post-implant]
Percent of DRG-S implanted patients that successfully respond to stimulation therapy as defined by >=50% reduction in reported pain score from baseline

Other Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Up to 12 months post-implant]
All complications of DRG-S trial, implant, and stimulation therapy will be reported

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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