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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-, 3-, 6-, 9-, and 12 months post-implant
Awards & highlights
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-, 3-, 6-, 9-, and 12 months post-implant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-, 3-, 6-, 9-, and 12 months post-implant
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 moreOther outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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
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Who is running the clinical trial?
Kenneth B ChapmanLead Sponsor
AbbottIndustry Sponsor
751 Previous Clinical Trials
478,145 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My knee arthritis is confirmed as mild, moderate, or severe by a recent scan.I have a collagen disease like lupus or scleroderma.I have had knee pain for over a year that affects my daily activities.I am expecting to have surgery during the trial period.I do not have any health or social conditions that prevent DRG stimulation.I am 21 years old or older.My knee X-rays show specific serious conditions.My current pain level is high, at or above a 6 out of 10.I have arthritis caused by an infection.I have signs of an infection in my knee.I do not speak English.My knee still hurts after 3 months of treatments like physical therapy and painkillers.I have a condition like fibromyalgia causing widespread pain.I have tried and not benefited from certain knee pain treatments or surgery.I am taking pain medication equivalent to 90 mg of morphine or more.I have an autoimmune or inflammatory condition like rheumatoid arthritis.
Research Study Groups:
This trial has the following groups:- Group 1: Non-operated Knee Osteoarthritis
- Group 2: Surgically Repaired Knee Osteoarthritis
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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