Dorsal Root Ganglion Stimulation for Joint Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Joint Diseases+8 More
Dorsal Root Ganglion Stimulation - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if a new pain treatment, dorsal root ganglion stimulation (DRG-S), can effectively treat arthritic pain of the knee.

Eligible Conditions
  • Joint Diseases
  • Arthritis of the Knee Joint
  • Arthropathy
  • Knee

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: 1-, 3-, 6-, 9-, and 12 months post-implant

Month 12
European Quality of Life 5 Dimension (EQ-5D)
Knee Range of Motion (ROM)
Medication Dosage
NRS pain scores
Pain Disability Index (PDI)
Patient Global Impression of Change (PGIC)
Short Form 36 Mental Component Summary (SF-36 MCS)
Timed Up and Go (TUG)
VAS pain scores
Western Ontario and McMaster Universities Arthritis Index (WOMAC) for knee pain patients
1-, 6-, 9-, and 12-months post-implant
Treatment success rate at other post-implant timepoints
3 months post-implant
Treatment success rate at 3 months
3-, 6-, and 12-months post-implant
Serum concentrations of molecular biomarkers
6- and 12-months post-implant
Kellgren-Lawrence System for Classification of Osteoarthritis
Month 12
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety Endpoints

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Non-operated Knee Osteoarthritis
1 of 2
Surgically Repaired Knee Osteoarthritis
1 of 2

Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Dorsal Root Ganglion Stimulation · No Placebo Group · N/A

Non-operated Knee Osteoarthritis
Device
Experimental Group · 1 Intervention: Dorsal Root Ganglion Stimulation · Intervention Types: Device
Surgically Repaired Knee Osteoarthritis
Device
Experimental Group · 1 Intervention: Dorsal Root Ganglion Stimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1-, 3-, 6-, 9-, and 12 months post-implant

Who is running the clinical trial?

AbbottIndustry Sponsor
730 Previous Clinical Trials
477,226 Total Patients Enrolled
3 Trials studying Joint Diseases
253 Patients Enrolled for Joint Diseases
Kenneth B ChapmanLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Failure of one or more prior interventional pain procedures, cooled radiofrequency ablation therapy, or regenerative medicine or prior surgery of the knee.
You have chronic knee pain for at least 1 year that interferes with functional activities.
You have pain on the VAS intensity scale.
You have had knee pain for at least 3 months, and have failed to improve with physical therapy and standard conservative therapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: November 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References