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NCT01824082 · ClinicalTrials.gov registry record · Phase 4

Treating Phantom Limb Pain Using Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study

A Phase 4 study of Phantom Limb Pain, sponsored by University of California, San Diego.

Completed
Registry status
Phase 4
Development phase
144
Enrollment target
4
Study locations

NCT01824082: Completed Phase 4 study of Phantom Limb Pain, sponsored by University of California, San Diego.

NCT01824082 is a Phase 4 study of Phantom Limb Pain that has completed, run by University of California, San Diego. The registered enrollment target is 144 participants, above the 111-participant average among 12 other Phantom Limb Pain trials with a reported enrollment target (30% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01824082, a Phase 4 study of Phantom Limb Pain, has completed, sponsored by University of California, San Diego.

COMPLETED
Registry status
Phase 4
Development phase
144 participants
Enrollment target
4
Study locations

Study Summary

When a limb is traumatically severed, pain perceived in the part of the body that no longer exists often develops. This is called "phantom limb" pain, and is different from "stump" pain, which is pain within the part of the limb that remains intact. Unfortunately, phantom pain resolves in only 16% of people, with the rest experiencing this pain for the remainder of the lives. There is currently no reliable treatment for phantom limb pain. The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut-as happens with a traumatic amputation-changes occur in the brain and spinal cord that actually worsen with increasing phantom pain. These abnormal changes may often be corrected by putting local anesthetic-termed a "peripheral nerve block"-on the injured nerve, keeping any "bad signals" from reaching the brain, with resolution of the phantom limb pain. However, when the nerve block ends after a few hours, the phantom pain returns. But, this demonstrates that the brain abnormalities-and phantom pain-that occur with an amputation may be dependent upon the "bad" signals being sent from the injured nerve(s), suggesting that a very long peripheral nerve block-lasting many days rather than hours-may permanently reverse the abnormal changes in the brain, and provide lasting relief from phantom pain. Until recently, extending a peripheral nerve block beyond 16 hours was unrealistic. However, a treatment option called a "continuous peripheral nerve block" is now available. This technique involves the placement of a tiny tube-smaller than a piece of spaghetti-through the skin and next to the nerves supplying the amputated limb. The tiny tube may be placed with minimal discomfort in about 15 minutes. Numbing medicine called local anesthetic is then infused through the tube, blocking any signals that the injured nerve sends to the spinal cord and brain. Using a small, portable infusion pump, this prolonged nerve block may be provided in individuals' own homes

Primary Outcome

Phantom pain will be assessed using a Numeric Rating Scale (NRS) as part of the Brief Pain Inventory (short form), with the "average" pain score designated as the primary endpoint. In addition, average and worst residual limb pain NRS will be recorded separately from the phantom pain scores. The NRS is a highly-sensitive measure of pain intensity with numbers ranging from 0 to 10, with zero equivalent to no pain and 10 equivalent to the worst imaginable pain. These data are 4 weeks after the ini

Conditions Studied

Interventions

  • DRUG Perineural infusion [continuous peripheral nerve block(s)]

Study Locations (4)

California

  • Veteran's Affairs Palo Alto Health Care System - Palo Alto
  • University of California, San Diego, Hillcrest Medical Center - San Diego

Maryland

  • Walter Reed Army National Medical Center - Bethesda

Ohio

  • Cleveland Clinic - Cleveland

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2013-12-01
Est. Completion 2020-10
Phase Phase 4
University of California, San Diego

775 total trials

What the finished NCT01824082 record still lists

NCT01824082 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, above the 111-participant average among 12 other Phantom Limb Pain trials with a reported enrollment target (30% higher).

The record links to 1 condition, with Phantom Limb Pain appearing as the primary indexed condition, and to 1 intervention - of which Perineural infusion [continuous peripheral nerve block(s)] is the first listed.

NCT01824082 reports a single indexed study location in California, Maryland, Ohio.

Frequently Asked Questions

What is clinical trial NCT01824082 about?

NCT01824082 is a clinical study titled "Treating Phantom Limb Pain Using Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study". When a limb is traumatically severed, pain perceived in the part of the body that no longer exists often develops. This is called "phantom limb" pain, and is different from "stump" pain, which is pain within the part of the limb that remains intact. Unfortunately, phantom pain resolves in only 16% o...

What is the current status of trial NCT01824082?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 144 participants. The study started on 2013-12-01. Estimated completion is 2020-10.

What conditions does trial NCT01824082 study?

This clinical trial studies the following conditions: Phantom Limb Pain.

What interventions are being tested in trial NCT01824082?

The interventions under investigation include: Perineural infusion [continuous peripheral nerve block(s)] (DRUG).

Who is sponsoring clinical trial NCT01824082?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01824082 being conducted?

This trial has 4 study locations across California, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Phantom Limb Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01824082's enrollment target sits among peer trials

144 3rd of 12 higher than 10 of 12 other Phantom Limb Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phantom Limb Pain 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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Source: ClinicalTrials.gov NCT01824082, the US trial registry maintained by the National Library of Medicine. NCT01824082 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.