Back to results

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

Primary Purpose

Phantom Limb Pain

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

direct observation

mental visualization

About this trial

This is an interventional treatment trial for Phantom Limb Pain focused on measuring phantom limb pain, limb amputation, Amputation, Phantom Limb, Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Walter Reed Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Arm Description

Direct observation of a sequence of right foot movements performed by the experimenter while visualizing moving the amputated or phantom right foot.

Direct observation of a sequence of left foot movements performed by the experimenter while visualizing moving the amputated or phantom left foot.

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.

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00639431

First Posted

December 4, 2007

Last Updated

August 11, 2014

Sponsor

Walter Reed Army Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00639431

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Unknown status

Study Start Date

December 2007 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Walter Reed Army Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Phantom Limb Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Direct observation of a sequence of right foot movements performed by the experimenter while visualizing moving the amputated or phantom right foot.

Arm Title

Arm Type

Experimental

Arm Description

Direct observation of a sequence of left foot movements performed by the experimenter while visualizing moving the amputated or phantom left foot.

Arm Title

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

direct observation

Intervention Description

direct observation of another person's foot moving

Intervention Type

Behavioral

Intervention Name(s)

mental visualization

Intervention Description

mentally imagining moving one's phantom foot/feet

Primary Outcome Measure Information:

Title

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jack W Tsao, MD

Phone

301-295-3643

jtsao@usuhs.mil

First Name & Middle Initial & Last Name or Official Title & Degree

Richard L Witt, PA-C

Phone

202-782-8705

richard.witt@amedd.army.mil

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jack W Tsao, MD

Organizational Affiliation

Walter Reed Army Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Walter Reed Army Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20307

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jack W Tsao, MD

Phone

301-295-3643

jtsao@usuhs.mil

First Name & Middle Initial & Last Name & Degree

Jack W Tsao, MD, PhD

First Name & Middle Initial & Last Name & Degree

Katie E Hughes, BS

First Name & Middle Initial & Last Name & Degree

Lindsay K Hussey-Andersen, AB

12. IPD Sharing Statement

Citations:

PubMed Identifier

564474

Citation

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.

Results Reference

background

PubMed Identifier

16858476

Citation

Manchikanti L, Singh V. Managing phantom pain. Pain Physician. 2004 Jul;7(3):365-75.

Results Reference

background

PubMed Identifier

2293143

Citation

Katz J, Melzack R. Pain 'memories' in phantom limbs: review and clinical observations. Pain. 1990 Dec;43(3):319-336. doi: 10.1016/0304-3959(90)90029-D.

Results Reference

background

PubMed Identifier

6657285

Citation

Jensen TS, Krebs B, Nielsen J, Rasmussen P. Phantom limb, phantom pain and stump pain in amputees during the first 6 months following limb amputation. Pain. 1983 Nov;17(3):243-256. doi: 10.1016/0304-3959(83)90097-0.

Results Reference

background

PubMed Identifier

2004259

Citation

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. doi: 10.1093/brain/114.1.615.

Results Reference

background

PubMed Identifier

7696611

Citation

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. doi: 10.1097/00001756-199412000-00047.

Results Reference

background

PubMed Identifier

7884476

Citation

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. doi: 10.1152/jn.1994.72.5.2517.

Results Reference

background

PubMed Identifier

10448212

Citation

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. doi: 10.1038/9145. No abstract available.

Results Reference

background

PubMed Identifier

10511638

Citation

Lotze M, Montoya P, Erb M, Hulsmann E, Flor H, Klose U, Birbaumer N, Grodd W. Activation of cortical and cerebellar motor areas during executed and imagined hand movements: an fMRI study. J Cogn Neurosci. 1999 Sep;11(5):491-501. doi: 10.1162/089892999563553.

Results Reference

background

PubMed Identifier

9204932

Citation

Birbaumer N, Lutzenberger W, Montoya P, Larbig W, Unertl K, Topfner 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. doi: 10.1523/JNEUROSCI.17-14-05503.1997.

Results Reference

background

PubMed Identifier

7777055

Citation

Flor H, Elbert T, Knecht S, Wienbruch C, Pantev C, Birbaumer N, Larbig W, Taub E. Phantom-limb pain as a perceptual correlate of cortical reorganization following arm amputation. Nature. 1995 Jun 8;375(6531):482-4. doi: 10.1038/375482a0.

Results Reference

background

PubMed Identifier

11166112

Citation

Grusser SM, Winter C, Muhlnickel 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. doi: 10.1016/s0306-4522(00)00491-7.

Results Reference

background

PubMed Identifier

1439826

Citation

Ramachandran VS, Rogers-Ramachandran D, Stewart M. Perceptual correlates of massive cortical reorganization. Science. 1992 Nov 13;258(5085):1159-60. doi: 10.1126/science.1439826. No abstract available.

Results Reference

background

PubMed Identifier

11673327

Citation

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. doi: 10.1093/brain/124.11.2268.

Results Reference

background

PubMed Identifier

8637922

Citation

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.

Results Reference

background

PubMed Identifier

10196540

Citation

Franz EA, Ramachandran VS. Bimanual coupling in amputees with phantom limbs. Nat Neurosci. 1998 Oct;1(6):443-4. doi: 10.1038/2161. No abstract available.

Results Reference

background

PubMed Identifier

14568486

Citation

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. doi: 10.1016/S1053-8119(03)00369-0.

Results Reference

background

PubMed Identifier

8008411

Citation

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):217-226. doi: 10.1016/0304-3959(94)90097-3.

Results Reference

background

PubMed Identifier

12373695

Citation

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. doi: 10.1053/rapm.2002.35169.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs