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A Study to Test the Effectiveness of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain

Primary Purpose

Amputation, Phantom Limb, Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mirror-box treatment
Mental visualization
Sponsored by
United States Department of Defense
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

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. Any single unilateral upper or lower limb amputation with the presence of phantom limb pain. No prior history of vertebral disk disease/condition, sciatica or radiculopathy. Normal neurological examination. Degree of pain evaluated by VAS scoring a minimum of 3 cm at time of screening for entry into the study, with a minimum of three episodes per week. Ability to follow study instructions and likely to complete all required visits. Exclusion Criteria: Age less than 18 or greater than 70. Bilateral upper or lower limb amputation. Presence of 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 which is currently performed routinely on patients by the TBI program at WRAMC and noted in the patient's medical record. 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 or psychiatrist in the 6 months prior to entry into the study. Subjects with lack of effort as determined by the neurologist or physiatrist. Subjects will be screened for effort using the Test of Memory Malingering (TOMM) first in order to exclude those with blatant exaggeration or malingering.

Sites / Locations

  • Walter Reed Army Medical CenterRecruiting

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

First Posted
March 9, 2006
Last Updated
June 13, 2007
Sponsor
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT00301444
Brief Title
A Study to Test the Effectiveness of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain
Official Title
A Pilot Study to Assess the Efficacy of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The researchers propose to conduct a pilot study on the efficacy of mirror-box and mental visualization treatments on phantom limb pain. 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, average intensity of pain, and worst intensity of pain. 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. Cognitive testing will also be performed to determine the effect of limb amputation on cognition and mood with results being compared to an on-going study of similar effects in patients with chronic (> 3 months) limb amputation. The inclusion of subjects with phantom limb pain in upper extremity amputations has recently been approved.
Detailed Description
A total of forty-eight (48) subjects with be enrolled - twenty-four (24) with any unilateral lower limb amputation and twenty-four (24) with any unilateral upper limb amputation. Subjects will be randomized for assignment into three treatment conditions: eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use mental visualization of foot or hand movements, eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use an open mirror- box to visualize the reflected image of their intact foot or hand, and eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use a closed mirror- box (unable to visualize a reflected image). Subjects will use their assigned therapy for 20 minutes daily. Subjects using the closed mirror-box or mental visualization treatments will be switched to mirror therapy if they have not significantly improved following 4 weeks. The subjects for this study will be recruited from the Walter Reed Army Medical Center Amputee clinic. Up to sixty (60) 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
Amputation, Phantom Limb, Pain
Keywords
phantom limb pain, limb amputation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
mirror-box treatment
Intervention Type
Behavioral
Intervention Name(s)
Mental visualization
Primary Outcome Measure Information:
Title
Significant decrease in the level of phantom limb pain at 4 weeks.
Secondary Outcome Measure Information:
Title
Significant decrease in the number and duration of daily phantom limb pain episodes at 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
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. Any single unilateral upper or lower limb amputation with the presence of phantom limb pain. No prior history of vertebral disk disease/condition, sciatica or radiculopathy. Normal neurological examination. Degree of pain evaluated by VAS scoring a minimum of 3 cm at time of screening for entry into the study, with a minimum of three episodes per week. Ability to follow study instructions and likely to complete all required visits. Exclusion Criteria: Age less than 18 or greater than 70. Bilateral upper or lower limb amputation. Presence of 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 which is currently performed routinely on patients by the TBI program at WRAMC and noted in the patient's medical record. 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 or psychiatrist in the 6 months prior to entry into the study. Subjects with lack of effort as determined by the neurologist or physiatrist. Subjects will be screened for effort using the Test of Memory Malingering (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
Email
jtsao@usuhs.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Richard L Witt, PA-C
Phone
202-782-8705
Email
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
Email
jtsao@usuhs.mil
First Name & Middle Initial & Last Name & Degree
Richard L Witt, PA-C
Phone
202-782-8705
Email
rlwittpa1@aol.com
First Name & Middle Initial & Last Name & Degree
Jack W Tsao, MD
First Name & Middle Initial & Last Name & Degree
Paul Pasquina, MD
First Name & Middle Initial & Last Name & Degree
Richard L Witt, PA-C
First Name & Middle Initial & Last Name & Degree
Brenda L Chan
First Name & Middle Initial & Last Name & Degree
Amanda Magee, PA-C

12. IPD Sharing Statement

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Citation
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A Study to Test the Effectiveness of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain

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