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Procedure
Residual Limb Pain in affected amputated limb for Phantom Limb Pain
N/A
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial looked at whether cooled radiofrequency ablation could help reduce pain, improve function, and quality of life for people with post-amputation neuroma-associated residual limb pain.
Eligible Conditions
- Phantom Limb Pain
- Neuroma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Numeric Rating Scale (NRS) for Pain at 6 Months
Secondary outcome measures
Median Change in Numeric Rating Scale (NRS) Scores for Pain
Medication Quantification Scale III Mean Score
Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Residual Limb Pain in affected amputated limbExperimental Treatment1 Intervention
Patient has residual limb pain in amputated limb and is scheduled to receive standard of care treatment of cooled radiofrequency ablation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cooled Radiofrequency Ablation
2019
N/A
~10
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,098 Previous Clinical Trials
1,778,622 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious mental health condition.You still have pain in your amputated limb, and it feels like it's burning or moving.You have not taken any experimental drugs in the last month.Your pain in a missing limb is not caused by a problem in your nerves.You experienced more than 50% pain relief after a special test to diagnose a nerve problem.You have had problems with alcohol or drugs in the last 5 years.You have been in pain for more than 6 months, even after trying different treatments like medications and physical therapy for 2 months.You are currently experiencing moderate to severe pain in your lower back that radiates down your legs.You have had any type of cancer, except for non-serious skin cancers like basal cell or squamous cell skin cancer, within the past 5 years.You are currently involved in a legal case related to pain in your remaining limb.You have had a lower limb amputation more than 1 year ago.You have a history of joint inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: Residual Limb Pain in affected amputated limb
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.
Is the enrollment period currently ongoing for potential participants?
"Data posted on clinicaltrials.gov states that this specific medical trial is no longer recruiting patients; the original posting date was October 27th 2019 and it was most recently updated November 21st 2022. There are, however, 41 other studies currently requiring participants to join them in their clinical research."
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