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NCT03449667 · ClinicalTrials.gov registry record · NA
Cryoanalgesia to Treat Post-Amputation Phantom Limb Pain: A Department of Defense Funded Multicenter Study
A NA study of Post-amputation Phantom Limb Pain, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 144
- Enrollment target
- 6
- Study locations
NCT03449667: Completed NA study of Post-amputation Phantom Limb Pain, sponsored by University of California, San Diego.
NCT03449667 is a NA study of Post-amputation Phantom Limb Pain that has completed, run by University of California, San Diego. The registered enrollment target is 144 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03449667, a NA study of Post-amputation Phantom Limb Pain, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 144 participants
- Enrollment target
- 6
- Study locations
Study Summary
When a limb is severed, pain perceived in the part of the body that no longer exists often develops and is called "phantom limb" pain. Unfortunately, phantom pain goes away in only 16% of afflicted individuals, and there is currently no reliable definitive treatment. The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut-as happens with an amputation-changes occur in the brain and spinal cord that actually increase with worsening phantom pain. These abnormal changes may often be corrected by putting local anesthetic-called a "nerve block"-on the injured nerve, effectively keeping any "bad signals" from reaching the brain with a simultaneous resolution of the phantom limb pain. However, when the nerve block resolves after a few hours, the phantom pain returns. But, this demonstrates that the brain abnormalities-and phantom pain-that occur with an amputation are not necessarily fixed, and may be dependent upon the "bad" signals being sent from the injured nerve(s), suggesting that a very long peripheral nerve block-lasting many months rather than hours-may permanently reverse the abnormal changes in the brain, and provide definitive relief from phantom pain. A prolonged nerve block lasting a few months may be provided by freezing the nerve using a process called "cryoneurolysis". The ultimate objective of the proposed research study is to determine if cryoanalgesia is an effective treatment for intractable post-amputation phantom limb pain. The proposed research study will include subjects with an existing lower extremity amputation who experience intractable daily phantom limb pain. A single ultrasound-guided treatment of cryoneurolysis (or sham block-determined randomly like a flip of a coin) will be applied to the target nerve(s) involved with the phantom pain. Although not required, each subject may return four months later for the alternative treatment (if the first treatment is sham, then the second treatment would be cryoneurolysis)
Primary Outcome
The difference in average daily phantom pain intensity at baseline and 4 months following the initial intervention (measured with the numeric rating scale as part of the Brief Pain Inventory with a minimum value of 0 and maximum value of 10, 0=no pain and 10=worst imaginable pain)
Conditions Studied
Interventions
- DEVICE Sham Comparator
- DEVICE Cryoneurolysis
Study Locations (6)
California
- Veterans Affairs Palo Alto Health Care System - Palo Alto
- University California San Diego - San Diego
- Naval Medical Center San Diego (NMCSD) - San Diego
Florida
- University of Florida - Gainesville
Maryland
- Walter Reed National Military Medical Center - Bethesda
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2018-03-23 |
| Est. Completion | 2022-03-17 |
| Phase | NA |
What the finished NCT03449667 record still lists
NCT03449667 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Post-amputation Phantom Limb Pain appearing as the primary indexed condition, and to 2 interventions - of which Sham Comparator is the first listed.
NCT03449667 lists 6 locations in 4 states (California, Florida, Maryland).
Frequently Asked Questions
What is clinical trial NCT03449667 about?
NCT03449667 is a clinical study titled "Cryoanalgesia to Treat Post-Amputation Phantom Limb Pain: A Department of Defense Funded Multicenter Study". When a limb is severed, pain perceived in the part of the body that no longer exists often develops and is called "phantom limb" pain. Unfortunately, phantom pain goes away in only 16% of afflicted individuals, and there is currently no reliable definitive treatment. The exact reason that phantom li...
What is the current status of trial NCT03449667?
This trial is currently completed. It is a NA study. The enrollment target is 144 participants. The study started on 2018-03-23. Estimated completion is 2022-03-17.
What conditions does trial NCT03449667 study?
This clinical trial studies the following conditions: Post-amputation Phantom Limb Pain.
What interventions are being tested in trial NCT03449667?
The interventions under investigation include: Sham Comparator (DEVICE), Cryoneurolysis (DEVICE).
Who is sponsoring clinical trial NCT03449667?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03449667 being conducted?
This trial has 6 study locations across California, Florida, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03449667's enrollment target sits among peer trials
144 706th of 2000 higher than 1,290 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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