Genetics and Phantom Limb Pain

NCT01517061 | Withdrawn

• 2 other identifiers: 12005412-NR-0054
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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.

Conditions

Polymorphism-Genetic; Amputation; Pain

Keywords

Phantom Limb Pain; Genetic Polymorphisms; Genetic Susceptibility; Amputation

Outcome Measures

Primary Outcomes (1)

• SNP frequency between PLP and non-PLP group

Secondary Outcomes (2)

• Gene expression profile between PLP and non-PLP group

• Epigenetic profile between PLP and non-PLP group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• NON PLP GROUP:
• same with PLP group except:
• Experienced PLP less than 10 times total and/or for less than two weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

Related Publications (3)

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

  PMID: 9767070 BACKGROUND

• 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.

  PMID: 6624883 BACKGROUND

• 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.

  PMID: 9272791 BACKGROUND

MeSH Terms

Conditions

Pain; Phantom Limb; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Disease Susceptibility; Disease Attributes

Study Officials

• Hyungsuk Kim, D.D.S.

  National Institute of Nursing Research (NINR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 25, 2012
• Study Start: January 3, 2012
• Study Completion: July 30, 2014
• Last Updated: December 12, 2019

Record last verified: 2014-07-30