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Dorsal Root Ganglion Stimulation for the Treatment of Arthritic Knee Pain

Primary Purpose

Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dorsal Root Ganglion Stimulation

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Dorsal Root Ganglion Stimulation, knee pain, knee arthritis, osteoarthritis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

The Spine and Pain Institute of New YorkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Non-operated Knee Osteoarthritis

Surgically Repaired Knee Osteoarthritis

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

VAS pain scores

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

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)

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)

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

Pain Disability Index (PDI)

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

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

Medication Dosage

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

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.

Knee Range of Motion (ROM)

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

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)

Kellgren-Lawrence System for Classification of Osteoarthritis

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

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

Full Information

NCT ID

NCT05103527

First Posted

September 23, 2021

Last Updated

April 29, 2022

Sponsor

Kenneth B Chapman

Collaborators

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT05103527

Brief Title

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

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

May 31, 2024 (Anticipated)

Study Completion Date

May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kenneth B Chapman

Collaborators

Abbott

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis, Knee Arthropathy

Keywords

Dorsal Root Ganglion Stimulation, knee pain, knee arthritis, osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Non-operated Knee Osteoarthritis

Arm Type

Experimental

Arm Description

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

Arm Title

Surgically Repaired Knee Osteoarthritis

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Dorsal Root Ganglion Stimulation

Intervention Description

Stimulation at L2, L3, L4 and S1 spinal levels

Primary Outcome Measure Information:

Title

Treatment success rate at 3 months

Description

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

Time Frame

3 months post-implant

Secondary Outcome Measure Information:

Title

VAS pain scores

Description

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

Time Frame