Study to Assess the Efficacy of Direct Observation and Mental Visualization of Foot Movements to Treat Bilateral Lower Limb Phantom Limb Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Walter Reed Army Medical Center
Sponsor:
Information provided by (Responsible Party):
Jack Tsao, MD, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00639431
First received: December 4, 2007
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

Because bilateral lower extremity amputees do not have an intact limb for use with the mirror, we are now proposing to conduct a pilot trial of two treatments for phantom limb pain (PLP) - direct observation of another person's foot moving versus mental visualization. The trial will last for 4 months and during the first month data will be gathered daily on the number of episodes of phantom limb pain, the average length of episodes, and the average intensity of pain in each phantom leg. In addition, the rapidity of pain relief, the length of therapy needed to sustain long-lasting pain relief, and whether use of these two treatment methods during rehabilitation can provide sustained and/or permanent pain relief will be determined. This study will test the hypothesis that direct observation of a limb while performing phantom limb movements will reduce phantom limb pain more than mental visualization of the phantom limb alone in subjects who have sustained a traumatic bilateral lower limb amputation.


Condition Intervention
Phantom Limb Pain
Behavioral: direct observation
Behavioral: mental visualization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study to Assess the Efficacy of Direct Observation and Mental Visualization of Foot Movements to Treat Bilateral Lower Limb Phantom Limb Pain

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • Significant decrease in the level of phantom limb pain at 4 weeks. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Significant decrease in the number and duration of daily phantom limb pain episodes at 4 weeks. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: December 2007
Estimated Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Direct observation of a sequence of right foot movements performed by the experimenter while visualizing moving the amputated or phantom right foot.
Behavioral: direct observation
direct observation of another person's foot moving
Experimental: 2
Direct observation of a sequence of left foot movements performed by the experimenter while visualizing moving the amputated or phantom left foot.
Behavioral: direct observation
direct observation of another person's foot moving
Experimental: 3
Direct observation of a sequence of left and right foot movements performed by the experimenter while visualizing moving the amputated or phantom left and right feet.
Behavioral: direct observation
direct observation of another person's foot moving
Experimental: 4
Mental visualization with closed eyes of a sequence movements performed with the right amputated or phantom foot.
Behavioral: mental visualization
mentally imagining moving one's phantom foot/feet
Experimental: 5
Mental visualization with closed eyes of a sequence movements performed with the left amputated or phantom foot.
Behavioral: mental visualization
mentally imagining moving one's phantom foot/feet
Experimental: 6
Mental visualization with closed eyes of a sequence movements performed with the left and right amputated or phantom feet.
Behavioral: mental visualization
mentally imagining moving one's phantom foot/feet

Detailed Description:

A total of forty-two (42) subjects with bilateral lower extremity amputations will be enrolled. Subjects will be randomized for assignment into two treatment conditions: twenty-one (21) subjects will use direct observation of another person's foot movements while twenty-one (21) will use mental visualization of foot movements (which will serve as the control group). Subjects in each group will be further be randomized for assignment into six treatment groups: direct observation or mental visualization of right lower extremity movements alone, direct observation or mental visualization of left lower extremity movements alone, or direct observation or mental visualization of simultaneous bilateral lower extremity movements. Subjects will use their assigned therapy for 20 minutes daily. The subjects for this study will be recruited from the Walter Reed Army Medical Center (WRAMC) Amputee clinic. Up to sixty (50) subjects will be recruited and screened according to the inclusion and exclusion criteria since we expect that some may not qualify or drop-out sooner than the scheduled 4-month completion time.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subjects, 18 to 70 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.
  • Traumatic bilateral lower limb amputation.
  • No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
  • Normal neurological examination.
  • Minimum of 3 phantom limb pain episodes each week in one phantom leg.
  • Degree of pain evaluated by VAS scoring a minimum of 3 cm at time of screening for entry into study.
  • Ability to follow study instructions and likely to complete all required visits.

Exclusion Criteria:

  • Age less than 18 or greater than 70.
  • Unilateral upper or lower limb amputation.
  • Severe traumatic brain injury (TBI) - permanent or temporary impairments of cognitive, physical, and psychosocial functions with an associated diminished or altered state of consciousness - as indicated by neuropsychological screening which is currently performed routinely on patients by the TBI program at WRAMC and noted in the patient's medical record. Subjects with diagnosis of mild TBI following TBI testing, but with a normal score (>42) on the Test of Memory Malingering (TOMM) (parts 1 or 2) can be included in the study.
  • Known uncontrolled systemic disease- 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 to its conclusion
  • Concurrent participation in another investigational drug or device study for phantom limb pain or participation in the 30 days immediately prior to study enrollment.
  • Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
  • Significant Axis I or II diagnosis determined by a neurologist in the 6 months prior to entry into the study, defined as a condition requiring initiation of medications or hospitalization with continuing medical treatment for the condition.
  • Subjects with lack of effort as determined by the neurologist. Subjects will be screened for effort using the TOMM first in order to exclude those with blatant exaggeration or malingering.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639431

Contacts
Contact: Jack W Tsao, MD 301-295-3643 jtsao@usuhs.mil
Contact: Richard L Witt, PA-C 202-782-8705 richard.witt@amedd.army.mil

Locations
United States, District of Columbia
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307
Contact: Jack W Tsao, MD    301-295-3643    jtsao@usuhs.mil   
Principal Investigator: Jack W Tsao, MD, PhD         
Sub-Investigator: Katie E Hughes, BS         
Sub-Investigator: Lindsay K Hussey-Andersen, AB         
Sponsors and Collaborators
Walter Reed Army Medical Center
Investigators
Principal Investigator: Jack W Tsao, MD Walter Reed Army Medical Center
  More Information

Publications:

Responsible Party: Jack Tsao, MD, Neurologist, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00639431     History of Changes
Other Study ID Numbers: DCI P07-71044
Study First Received: December 4, 2007
Last Updated: August 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
phantom limb pain
limb amputation
Amputation
Phantom Limb
Pain

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pain

ClinicalTrials.gov processed this record on October 19, 2014