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Polymorphism-GeneticNCT01517061

Genetics and Phantom Limb Pain

An observational study of Polymorphism-Genetic and Amputation, run by National Institute of Nursing Research (NINR).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Background: Many people who lose a limb feel pain in the missing limb. This feeling is called phantom limb pain. Researchers do not fully understand what causes this pain. Differences in people's genes may play a role. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Polymorphism-Genetic, Amputation, Pain
How many people
0 participants
Where
No sites listed yet
Study dates
3 Jan 2012to 30 Jul 2014
Phase
Observational
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • PLP GROUP:
  • at least 18 years of age
  • Single or multiple upper and/or lower limb amputation
  • At least three months post-amputation
  • Ability to follow study instructions in English
  • Currently present on-going PLP for at least one month and at least 3 times per week
Show all 9Show fewer
  • NON PLP GROUP:
  • -same with PLP group except:
  • --Experienced PLP less than 10 times total and/or for less than two weeks

Who cannot join

  • BOTH PLP AND NON-PLP GROUPS:
  • Chronic systemic disease which might affect pain sensitivity and ability to participate in this study s blood draw
  • Any disease (such as hemophilia) or medication regimen (such as warfarin) increasing hemorrhage that would make a blood draw dangerous or inadvisable for the subject
  • Known uncontrolled systemic diseases; known cancer not in remission, known on-going infection, lupus, kidney disease requiring dialysis, any other systemic disease which might affect ability to participate in this study s blood draw
  • Inability to provide his/her own informed consent

About this study

Official title: Integrative Genomic Analysis In Phantom Limb Pain

Background:

  • Many people who lose a limb feel pain in the missing limb. This feeling is called phantom limb pain. Researchers do not fully understand what causes this pain. Differences in people's genes may play a role. Comparing the genes of people with and without phantom limb pain may help researchers better understand this feeling, who is likely to develop it, and how to treat it.
Read more

Objectives:

  • To study whether genetic differences affect phantom limb pain.

Eligibility:

  • Individuals at least 18 years of age who have lost an arm or leg at least 3 months ago.

Design:

  • Participants will be screened with a medical history and physical exam.
  • Participants will answer questions about how they lost the limb, and whether they feel phantom limb pain. They will also have a test to measure their sensitivity to heat and cold.
  • Participants will provide a blood sample for genetic testing.
Read the detailed description

Objectives:

The proposed clinical trial will investigate the role of the human genome including genetic variations and gene expression profiles on the development of phantom limb pain (PLP).

Study population:

Patients will be recruited from military personnel with major limb amputations. A total of one thousand subjects with upper or lower extremity amputations of any level will be enrolled in this study.

Design:

Eight hundred subjects with chronic PLP (PLP patient) and 200 patients without PLP (non-PLP patient) will assess the severity of their pain symptom. Each participant will undergo a routine blood draw from which DNA and RNA will be harvested.

Outcome measures:

Using Affymetrix SNP 6.0 technology, which identifies up to 1 million single nucleotide polymorphisms (SNPs) and 1 million copy number variations in the human genome, the differences in genomic variations between the PLP and the non-PLP patients will be analyzed. An extreme subset of PLP patients will be tested for their quantitative sensory function and profiled gene expression and epigenetic pattern with the Affymetrix Human Exon ST 1.0 and Illumina Genome Analyzer IIx. These integrative genomic analyses using genetic variations, gene expression and epigenetic profile could explain why some amputees experience chronic PLP and some do not. By studying these responses in patient samples, we will evaluate the role of genomic factors in PLP. SNP frequencies, gene expression and epigenetic profiles between PLP and non-PLP groups will be analyzed.

Keywords
Phantom Limb Pain, Genetic Polymorphisms, Genetic Susceptibility, Amputation
Medical subject headings
Pain, Phantom Limb, Genetic Predisposition to Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SNP frequency between PLP and non-PLP group

Secondary outcomes (2)

  1. Gene expression profile between PLP and non-PLP group

  2. Epigenetic profile between PLP and non-PLP group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2012 (estimated)
  2. Study start3 Jan 2012
  3. Study completion30 Jul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Retrospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01517061
Sponsor's protocol ID
120054
Other IDs
12-NR-0054
Status last verified
30 Jul 2014
First submitted
24 Jan 2012
Last updated
12 Dec 2019
Results posted
No

Publications

  • Weinstein SM. Phantom limb pain and related disorders. Neurol Clin. 1998 Nov;16(4):919-36. doi: 10.1016/s0733-8619(05)70105-5.

    PubMed 9767070

  • Sherman RA, Sherman CJ. Prevalence and characteristics of chronic phantom limb pain among American veterans. Results of a trial survey. Am J Phys Med. 1983 Oct;62(5):227-38.

    PubMed 6624883

  • Montoya P, Larbig W, Grulke N, Flor H, Taub E, Birbaumer N. The relationship of phantom limb pain to other phantom limb phenomena in upper extremity amputees. Pain. 1997 Aug;72(1-2):87-93. doi: 10.1016/s0304-3959(97)00004-3.

    PubMed 9272791

Questions about this trial

What is this clinical trial studying?

An observational study of Polymorphism-Genetic and Amputation, run by National Institute of Nursing Research (NINR).

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 9 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: withdrawn, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SNP frequency between PLP and non-PLP group. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01517061, which also lists 3 linked publications.

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 12 Dec 2019.

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