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Neurostimulation

Dorsal Root Ganglion Stimulation for Knee Arthritis

N/A
Recruiting
Research Sponsored by Kenneth B Chapman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current pain score on visual analog scale (VAS) intensity ≥60 mm
Primary complaint of chronic knee pain for at least 1 year that interferes with functional activities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-, 3-, 6-, 9-, and 12 months post-implant
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for adults over 21 with chronic knee pain due to arthritis, who have tried other treatments like physical therapy and medications without relief. It's for those not suitable or willing to undergo knee surgery, including patients with a history of surgical repair. Participants must have moderate to severe arthritis confirmed by recent scans and significant pain despite past interventions.Check my eligibility
What is being tested?
The study tests if Dorsal Root Ganglion Stimulation (DRG-S) can effectively relieve arthritic knee pain. DRG-S targets specific nerves affected by tissue damage or dysfunction from conditions like trauma or osteoarthritis, aiming to reduce mechanical pain in the knee.See study design
What are the potential side effects?
While the trial description does not list specific side effects, similar procedures may cause discomfort at the stimulation site, infection risk, nerve damage potential, and possible changes in pain sensation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My current pain level is high, at or above a 6 out of 10.
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I have had knee pain for over a year that affects my daily activities.
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I have tried and not benefited from certain knee pain treatments or surgery.
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I am 21 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-, 3-, 6-, 9-, and 12 months post-implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-, 3-, 6-, 9-, and 12 months post-implant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment success rate at 3 months
Secondary outcome measures
European Quality of Life 5 Dimension (EQ-5D)
Kellgren-Lawrence System for Classification of Osteoarthritis
Knee Range of Motion (ROM)
+9 more
Other outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Surgically Repaired Knee OsteoarthritisExperimental Treatment1 Intervention
DRG-S for knee osteoarthritis patients with history of surgical repair of the knee
Group II: Non-operated Knee OsteoarthritisExperimental Treatment1 Intervention
DRG-S for knee osteoarthritis patients with no history of knee surgery

Find a Location

Who is running the clinical trial?

Kenneth B ChapmanLead Sponsor
AbbottIndustry Sponsor
747 Previous Clinical Trials
476,945 Total Patients Enrolled

Media Library

Dorsal Root Ganglion Stimulation (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05103527 — N/A
Chronic Knee Pain Research Study Groups: Non-operated Knee Osteoarthritis, Surgically Repaired Knee Osteoarthritis
Chronic Knee Pain Clinical Trial 2023: Dorsal Root Ganglion Stimulation Highlights & Side Effects. Trial Name: NCT05103527 — N/A
Dorsal Root Ganglion Stimulation (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05103527 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are subjects being accepted for this trial at present?

"Affirmative. Based on the data from clinicaltrials.gov, this medical study is still enrolling participants since it was first posted in January 1st 2022 and last updated April 29th 2022. The trial requires 30 volunteers to be recruited at one specified site."

Answered by AI

What is the scope of participants for this experiment?

"Absolutely! Details hosted on clinicaltrials.gov validate that the trial is in progress, with an origin date of January 1st 2022 and a recent update from April 29th 2022. The research project has a goal of enlisting 30 participants at one centre."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

What questions have other patients asked about this trial?

Compensation for time and transportation?
PatientReceived no prior treatments
Recent research and studies
~3 spots leftby May 2024