Virtual Integrated Environment in Decreasing Phantom Limb Pain

NCT01462461 | Completed

• 2 other identifiers: 20448W81XWH-09-2-0148
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if observing a virtual arm decreases phantom limb pain (PLP) in upper extremity amputees.

Conditions

Phantom Limb

Keywords

Phantom Limb; Amputation, Traumatic; Electromyography; Visual Analog Pain Scale

Outcome Measures

Primary Outcomes (1)

• Change in Phantom Limb Pain Severity

  Severity of PLP will be assessed using the Visual Analog Scale (VAS), which wil consist of a 10-cm horizontal line across which subjects will place a mark corresponding to the level of phantom limb pain he or she experiences. The distance in centimeters from the low end of the VAS to the subject's mark will be used as a numeric index of pain severity. The VAS score over 4 weeks of VIE treatment will be averaged and compared to the baseline VAS score at the start of treatment.

  Baseline (0 weeks) and 4 weeks

Secondary Outcomes (1)

• Consistency of sEMG recordings

  Baseline (0 weeks) and 4 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Seven unilateral, upper-extremity amputees completed the study. These subjects were either trans-radial (n=4) or trans-humeral (n=3) amputees.

You may qualify if:

• Male or female subjects, 18 to 65 years of age, active duty military, beneficiary, or retiree.
• Written informed consent and written authorization for use or release of health and research study information.
• At least one upper-limb amputation (trans radial or trans humeral) at any time prior to enrollment.
• No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
• Normal neurological examination with the exception of limb amputation.
• Ability to follow study instructions and likely to complete all required visits.
• Experiencing PLP at least 3 times a week at an intensity of at least 3 out of 10 at the time of enrollment.

You may not qualify if:

• Presence of mild to severe traumatic brain injury - permanent or temporary impairments of cognitive, physical, and psychosocial functions with an associated diminished or altered state of consciousness - as indicated by neuropsychological screening that is currently performed routinely on patients by the traumatic brain injury (TBI) program at Walter Reed National Military Medical Center (WRNMMC) and noted in the patient's medical record.
• Known uncontrolled systemic disease
• Participation (either concurrently or in the 30 days prior to enrollment) in another study for treatment of PLP
• Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound study results, or interfere significantly with the subject's participation in the study.
• Significant Axis I or II diagnosis determined by a neurologist or psychiatrist in the 6 months prior to entry into the study
• Subjects with lack of effort as determined by the neurologist or psychiatrist. Subjects will be screened for effort using the Test of Memory Malingering (TOMM) in order to exclude those with blatant exaggeration or malingering. Subjects who score lower than 42/50 on the TOMM-2 will not continue in the study

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Walter Reed National Military Medical Center (WRNMMC)

Bethesda, Maryland, 20889, United States

Location

Related Publications (6)

• Ramachandran VS, Rogers-Ramachandran D. Synaesthesia in phantom limbs induced with mirrors. Proc Biol Sci. 1996 Apr 22;263(1369):377-86. doi: 10.1098/rspb.1996.0058.

  PMID: 8637922 BACKGROUND

• Ramachandran VS, Hirstein W. The perception of phantom limbs. The D. O. Hebb lecture. Brain. 1998 Sep;121 ( Pt 9):1603-30. doi: 10.1093/brain/121.9.1603.

  PMID: 9762952 BACKGROUND

• Carlen PL, Wall PD, Nadvorna H, Steinbach T. Phantom limbs and related phenomena in recent traumatic amputations. Neurology. 1978 Mar;28(3):211-7. doi: 10.1212/wnl.28.3.211.

  PMID: 564474 BACKGROUND

• Chan BL, Witt R, Charrow AP, Magee A, Howard R, Pasquina PF, Heilman KM, Tsao JW. Mirror therapy for phantom limb pain. N Engl J Med. 2007 Nov 22;357(21):2206-7. doi: 10.1056/NEJMc071927. No abstract available.

  PMID: 18032777 BACKGROUND

• Hauschild M, Davoodi R, Loeb GE. A virtual reality environment for designing and fitting neural prosthetic limbs. IEEE Trans Neural Syst Rehabil Eng. 2007 Mar;15(1):9-15. doi: 10.1109/TNSRE.2007.891369.

  PMID: 17436870 BACKGROUND

• Zeher MJ, Armiger RS, Burck JM, Moran C, Kiely JB, Weeks SR, Tsao JW, Pasquina PF, Davoodi R, Loeb G. Using a virtual integration environment in treating phantom limb pain. Stud Health Technol Inform. 2011;163:730-6.

  PMID: 21335889 BACKGROUND

MeSH Terms

Conditions

Phantom Limb; Amputation, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Paul F Pasquina, MD, MC

  Walter Reed National Military Medical Center (WRNMMC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 31, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

US (1)