Phantom LimbPhase 1NCT00388752
Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation
A Phase 1 study testing Acupuncture in people with Phantom Limb and Residual Limb Pain, run by Walter Reed Army Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to identify the best treatment sequence and combination of acupuncture points for the treatment of phantom limb or residual limb pain in the traumatic/surgical amputee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb, Residual Limb Pain, Traumatic Amputation
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Amputees with traumatic/surgical amputation of a limb (greater than fingers or toes) secondary to trauma or peripheral vascular disease
- Amputees who have been cleared to begin prosthetic fitting
- Phantom and/or residual limb pain reported must be >/= 3/10
- Active duty military or dependent eligible for military benefit >/=18 years old
Who cannot join
- Congenital limb absence
- Pregnancy
- Any skin changes on the ear or scalp that would preclude placement of acupuncture needles
- Patients intubated and unable to give consent
- Patients with traumatic brain injury (TBI) diagnosed as greater than mild
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001
Tammy J Penhollow, D.O.
About this study
Official title: Acupuncture for Post Amputation Limb Pain: A Pilot Study
The purpose of this study is to identify the best treatment sequence and combination of acupuncture points for the treatment of phantom limb or residual limb pain in the traumatic/surgical amputee.
Read the detailed description
The purpose of this pilot study is to identify the optimum combination of acupuncture points and treatment sequence in the treatment of post amputation limb pain in terms of the change in Phantom Limb Pain (PLP) and/or Residual Limb Pain (RLP) as measured by the Visual Analogue Scale (VAS) and the McGill Short Form Pain Questionnaire (SF-MPQ). Further, any side effects associated with the acupuncture treatment regimens, time requirements, and patient compliance with the treatment regimens will be estimated.
Study participants will be randomized to one of three acupuncture treatments: Chinese Scalp Acupuncture, French Auricular Acupuncture, or a combination of both.
- Conditions
- Phantom Limb, Residual Limb Pain, Traumatic Amputation, Amputation
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Phantom limb pain, Residual limb pain, amputation, amputee, traumatic, surgical, Traumatic amputation upper extremity, Traumatic amputation lower extremity, Surgical amputation upper extremity, Surgical amputation lower extremity
- Medical subject headings
- Phantom Limb, Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of phantom limb pain (PLP) and/or residual limb pain (RLP) pre/post each treatment
Level (Visual Analogue Scale [VAS]) of PLP and/or RLP pre/post each treatment
Level (VAS) of PLP and/or RLP one hour post each treatment
Presence/absence and level of PLP and/or RLP two weeks after final treatment
Secondary outcomes (6)
Changes in medication regimen during treatment period and after final treatment
Changes in sleep habits during treatment period and after final treatment
Any change in phantom limb sensation (PLP) after final treatment
Length of time for each treatment
Any discomfort associated with each treatment
Overall satisfaction at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Tammy J Penhollow, D.O., Principal investigator, Walter Reed Army Medical Center: Anesthesia & Operative Service, Dept of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388752
- Sponsor's protocol ID
- #06-20011A
- Status last verified
- Oct 2006
- First submitted
- 16 Oct 2006
- Last updated
- 6 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Post Amputation Limb Pain: A Pilot Study
- ClinicalTrials.gov ID
- NCT00388752
- Acronym / sponsor ID
- #06-20011A
- Conditions
- Phantom Limb, Residual Limb Pain, Traumatic Amputation, Amputation
- Keywords
- Acupuncture, Phantom limb pain, Residual limb pain, amputation, amputee, traumatic, surgical, Traumatic amputation upper extremity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- Sep 2006
- First posted
- 17 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify the best treatment sequence and combination of acupuncture points for the treatment of phantom limb or residual limb pain in the traumatic/surgical amputee.
Detailed description
The purpose of this pilot study is to identify the optimum combination of acupuncture points and treatment sequence in the treatment of post amputation limb pain in terms of the change in Phantom Limb Pain (PLP) and/or Residual Limb Pain (RLP) as measured by the Visual Analogue Scale (VAS) and the McGill Short Form Pain Questionnaire (SF-MPQ). Further, any side effects associated with the acupuncture treatment regimens, time requirements, and patient compliance with the treatment regimens will be estimated.
Study participants will be randomized to one of three acupuncture treatments: Chinese Scalp Acupuncture, French Auricular Acupuncture, or a combination of both.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Amputees with traumatic/surgical amputation of a limb (greater than fingers or toes) secondary to trauma or peripheral vascular disease
- Amputees who have been cleared to begin prosthetic fitting
- Phantom and/or residual limb pain reported must be >/= 3/10
- Active duty military or dependent eligible for military benefit >/=18 years old
Key exclusion criteria (5 listed)
- Congenital limb absence
- Pregnancy
- Any skin changes on the ear or scalp that would preclude placement of acupuncture needles
- Patients intubated and unable to give consent
- Patients with traumatic brain injury (TBI) diagnosed as greater than mild
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture | Procedure or surgery | – |
Primary outcome
Presence/absence of phantom limb pain (PLP) and/or residual limb pain (RLP) pre/post each treatment
Level (Visual Analogue Scale [VAS]) of PLP and/or RLP pre/post each treatment
Level (VAS) of PLP and/or RLP one hour post each treatment
Presence/absence and level of PLP and/or RLP two weeks after final treatment
6 secondary outcomes
Changes in medication regimen during treatment period and after final treatment
Changes in sleep habits during treatment period and after final treatment
Any change in phantom limb sensation (PLP) after final treatment
Length of time for each treatment
Any discomfort associated with each treatment
Overall satisfaction at the end of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tammy J Penhollow, D.O. principal investigator
Walter Reed Army Medical Center: Anesthesia & Operative Service, Dept of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acupuncture in people with Phantom Limb and Residual Limb Pain, run by Walter Reed Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tammy J Penhollow, D.O. (800-759-8888 ext. 146-9290, tammy.penhollow@na.amedd.army.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence/absence of phantom limb pain (PLP) and/or residual limb pain (RLP) pre/post each treatment. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2007.