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

NCT00639431 | Unknown

• 1 other identifier: DCI P07-71044
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Phantom Limb Pain

Keywords

phantom limb pain; limb amputation; Amputation; Phantom Limb; Pain

Outcome Measures

Primary Outcomes (1)

• Significant decrease in the level of phantom limb pain at 4 weeks.

  4 weeks

Secondary Outcomes (1)

• Significant decrease in the number and duration of daily phantom limb pain episodes at 4 weeks.

  4 weeks

Study Arms (6)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

3

EXPERIMENTAL

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

4

EXPERIMENTAL

Mental visualization with closed eyes of a sequence movements performed with the right amputated or phantom foot.

Behavioral: mental visualization

5

EXPERIMENTAL

Mental visualization with closed eyes of a sequence movements performed with the left amputated or phantom foot.

Behavioral: mental visualization

6

EXPERIMENTAL

Mental visualization with closed eyes of a sequence movements performed with the left and right amputated or phantom feet.

Behavioral: mental visualization

Interventions

direct observation BEHAVIORAL

direct observation of another person's foot moving

1; 2; 3

mental visualization BEHAVIORAL

mentally imagining moving one's phantom foot/feet

4; 5; 6

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Phantom Limb; Pain

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

Study Officials

• Jack W Tsao, MD

  Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jack W Tsao, MD

CONTACT

301-295-3643; jtsao@usuhs.mil

Richard L Witt, PA-C

CONTACT

202-782-8705; richard.witt@amedd.army.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: March 20, 2008
• Study Start: December 1, 2007
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 12, 2014

Record last verified: 2014-08

Locations

US (1)