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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
Primary complaint of chronic knee pain for at least 1 year that interferes with functional activities
Age >= 21 years old
Must not have
Collagen diseases (systemic lupus erythematosus, Scleroderma, etc)
Scheduled for or anticipating any surgery during the trial period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-, 3-, 6-, 9-, and 12 months post-implant
Awards & highlights
No Placebo-Only Group

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.
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.
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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I have had knee pain for over a year that affects my daily activities.
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I am 21 years old or older.
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My current pain level is high, at or above a 6 out of 10.
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I have tried and not benefited from certain knee pain treatments or surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a collagen disease like lupus or scleroderma.
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I am expecting to have surgery during the trial period.
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I do not have any health or social conditions that prevent DRG stimulation.
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My knee X-rays show specific serious conditions.
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I have arthritis caused by an infection.
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I have signs of an infection in my knee.
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I do not speak English.
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I have a condition like fibromyalgia causing widespread pain.
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I am taking pain medication equivalent to 90 mg of morphine or more.
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I have an autoimmune or inflammatory condition like rheumatoid arthritis.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment success rate at 3 months
Secondary study objectives
European Quality of Life 5 Dimension (EQ-5D)
Kellgren-Lawrence System for Classification of Osteoarthritis
Knee Range of Motion (ROM)
+9 more
Other study objectives
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
755 Previous Clinical Trials
484,805 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
~8 spots leftby Jan 2026
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