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

Sponsored by:	Department of Defense
Information provided by:	Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00639431

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 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

MedlinePlus related topics: Foot Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Study to Assess the Efficacy of Direct Observation and Mental Visualization of Foot Movements to Treat Bilateral Lower Limb Phantom Limb Pain

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:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 direct observation of another person's foot moving
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 direct observation of another person's foot moving
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 direct observation of another person's foot moving
4: Experimental 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
5: Experimental 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
6: Experimental 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 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

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

Department of Defense

Investigators

Principal Investigator:

Jack W Tsao, MD

Walter Reed Army Medical Center

More Information

Publications:

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Cohen LG, Bandinelli S, Findley TW, Hallett M. Motor reorganization after upper limb amputation in man. A study with focal magnetic stimulation. Brain. 1991 Feb;114 ( Pt 1B):615-27.

Elbert T, Flor H, Birbaumer N, Knecht S, Hampson S, Larbig W, Taub E. Extensive reorganization of the somatosensory cortex in adult humans after nervous system injury. Neuroreport. 1994 Dec 20;5(18):2593-7.

Kew JJ, Ridding MC, Rothwell JC, Passingham RE, Leigh PN, Sooriakumaran S, Frackowiak RS, Brooks DJ. Reorganization of cortical blood flow and transcranial magnetic stimulation maps in human subjects after upper limb amputation. J Neurophysiol. 1994 Nov;72(5):2517-24.

Lotze M, Grodd W, Birbaumer N, Erb M, Huse E, Flor H. Does use of a myoelectric prosthesis prevent cortical reorganization and phantom limb pain? Nat Neurosci. 1999 Jun;2(6):501-2. No abstract available.

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Birbaumer N, Lutzenberger W, Montoya P, Larbig W, Unertl K, Töpfner S, Grodd W, Taub E, Flor H. Effects of regional anesthesia on phantom limb pain are mirrored in changes in cortical reorganization. J Neurosci. 1997 Jul 15;17(14):5503-8.

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Grüsser SM, Winter C, Mühlnickel W, Denke C, Karl A, Villringer K, Flor H. The relationship of perceptual phenomena and cortical reorganization in upper extremity amputees. Neuroscience. 2001;102(2):263-72.

Ramachandran VS, Rogers-Ramachandran D, Stewart M. Perceptual correlates of massive cortical reorganization. Science. 1992 Nov 13;258(5085):1159-60. No abstract available.

Lotze M, Flor H, Grodd W, Larbig W, Birbaumer N. Phantom movements and pain. An fMRI study in upper limb amputees. Brain. 2001 Nov;124(Pt 11):2268-77.

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

Franz EA, Ramachandran VS. Bimanual coupling in amputees with phantom limbs. Nat Neurosci. 1998 Oct;1(6):443-4. No abstract available.

Jackson PL, Lafleur MF, Malouin F, Richards CL, Doyon J. Functional cerebral reorganization following motor sequence learning through mental practice with motor imagery. Neuroimage. 2003 Oct;20(2):1171-80.

Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994 Feb;56(2):217-26.

Bone M, Critchley P, Buggy DJ. Gabapentin in postamputation phantom limb pain: a randomized, double-blind, placebo-controlled, cross-over study. Reg Anesth Pain Med. 2002 Sep-Oct;27(5):481-6.

Study ID Numbers:	DCI P07-71044
Study First Received:	December 4, 2007
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00639431
Health Authority:	United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:

phantom limb pain
limb amputation
Amputation
Phantom Limb
Pain

Study placed in the following topic categories:

Signs and Symptoms
Neurologic Manifestations
Pain

Phantom Limb
Neurobehavioral Manifestations
Perceptual Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009