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Acupuncture for Phantom Limb Pain

Phase 1

Waitlist Available

Led By Tammy J Penhollow, D.O.

Research Sponsored by Walter Reed Army Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phantom and/or residual limb pain reported must be >/= 3/10

Amputees with traumatic/surgical amputation of a limb (greater than fingers or toes) secondary to trauma or peripheral vascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will test different acupuncture point combinations and treatment sequences to find the most effective way to treat phantom limb or residual limb pain in people who have had an amputation.

Who is the study for?

This trial is for adults over 18 who have had a limb amputated due to injury or vascular disease, are ready for prosthetic fitting, and experience significant phantom or residual limb pain. It's not suitable for those with congenital limb loss, pregnant individuals, skin issues preventing acupuncture, or severe traumatic brain injury.Check my eligibility

What is being tested?

The study aims to determine the most effective sequence and combination of acupuncture points to alleviate phantom limb or residual limb pain in individuals who have undergone an amputation due to trauma or surgery.See study design

What are the potential side effects?

Acupuncture may cause minor side effects such as soreness at needle insertion sites, minor bleeding, bruising, and less commonly dizziness or fainting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My limb pain is at least a 3 on a scale of 10.

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I have had an amputation due to injury or blood vessel disease.

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I have been approved to start fitting for a prosthetic.

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I am over 18 and eligible for military benefits as active duty or a dependent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Level (VAS) of PLP and/or RLP one hour post each treatment

Level (Visual Analogue Scale [VAS]) of PLP and/or RLP pre/post each treatment

Presence/absence and level of PLP and/or RLP two weeks after final treatment

+1 more

Secondary outcome measures

Any change in phantom limb sensation (PLP) after final treatment

Any discomfort associated with each treatment

Changes in medication regimen during treatment period and after final treatment

+3 more

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Walter Reed Army Medical CenterLead Sponsor

69 Previous Clinical Trials

20,918 Total Patients Enrolled

Tammy J Penhollow, D.O.Principal InvestigatorWalter Reed Army Medical Center: Anesthesia & Operative Service, Dept of Surgery

Media Library

Acupuncture Clinical Trial Eligibility Overview. Trial Name: NCT00388752 — Phase 1

Residual Limb Pain Research Study Groups:

Residual Limb Pain Clinical Trial 2023: Acupuncture Highlights & Side Effects. Trial Name: NCT00388752 — Phase 1

Acupuncture 2023 Treatment Timeline for Medical Study. Trial Name: NCT00388752 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently taking on new participants?

"Data from clinicaltrials.gov reveals that, in spite of being initially published on September 1st 2006 and last updated on June 5th 2007, this trial is not currently enrolling volunteers. Nevertheless, there are 98 other trials seeking applicants as we speak."

Answered by AI

Has this therapeutic practice been endorsed by the Federal Drug Administration?

"This therapeutic intervention received a score of 1 on the safety scale due to its Phase 1 status, implying that there is only preliminary evidence supporting efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation

2006. "Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00388752.