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NCT06071715 · ClinicalTrials.gov registry record · NA

Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation

A NA study of Phantom Limb Pain and Amputation, Traumatic, sponsored by University of California, San Diego.

Completed
Registry status
NA
Development phase
12
Enrollment target
1
Study location

NCT06071715 is a NA study of Phantom Limb Pain and Amputation, Traumatic that has completed, run by University of California, San Diego. The registered enrollment target is 12 participants, below the 122-participant average among 12 other Phantom Limb Pain trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06071715, a NA study of Phantom Limb Pain and Amputation, Traumatic, has completed, sponsored by University of California, San Diego.

COMPLETED
Registry status
NA
Development phase
12 participants
Enrollment target
1
Study location

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 pilot study will include subjects with an existing above-knee 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 major nerves of the thigh. Although not required, each subject may return 4-6 months later for the alternative treatment (if the first treatment is sham, then the second treatment would be cryoneurolysis) so that all participants have

Interventions

  • DEVICE ACTIVE cryoneurolysis
  • DEVICE SHAM cryoneurolysis

Study Locations (1)

California

  • University of California San Diego - La Jolla

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2024-02-12
Est. Completion 2025-10-09
Phase NA

Sponsor

University of California, San Diego

775 total trials

What the Registry Record Tells You About NCT06071715

The ClinicalTrials.gov registry entry for NCT06071715 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 122-participant average among 12 other Phantom Limb Pain trials with a reported enrollment target (90% lower). The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Phantom Limb Pain appearing as the primary indexed condition, and to 2 interventions - of which ACTIVE cryoneurolysis is the first listed.

NCT06071715 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT06071715 about?

NCT06071715 is a clinical study titled "Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation". 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 NCT06071715?

This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2024-02-12. Estimated completion is 2025-10-09.

What conditions does trial NCT06071715 study?

This clinical trial studies the following conditions: Phantom Limb Pain, Amputation, Traumatic, Phantom Pain Following Amputation of Lower Limb, Amputation, Surgical.

What interventions are being tested in trial NCT06071715?

The interventions under investigation include: ACTIVE cryoneurolysis (DEVICE), SHAM cryoneurolysis (DEVICE).

Who is sponsoring clinical trial NCT06071715?

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

Where is trial NCT06071715 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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