Phantom Limb PainNCT00639431
Study to Assess the Efficacy of Direct Observation and Mental Visualization of Foot Movements to Treat Bilateral Lower Limb Phantom Limb Pain
A study testing direct observation and mental visualization in people with Phantom Limb Pain, run by Walter Reed Army Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- direct observation and mental visualization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
Jack W Tsao, MD, 301-295-3643, jtsao@usuhs.mil
Jack W Tsao, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Phantom Limb Pain
- Being tested
- direct observation, mental visualization
- Keywords
- phantom limb pain, limb amputation, Amputation, Phantom Limb, Pain
- Medical subject headings
- Phantom Limb, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct observationBehavioural
direct observation of another person's foot moving
mental visualizationBehavioural
mentally imagining moving one's phantom foot/feet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Direct observation of a sequence of right foot movements performed by the experimenter while visualizing moving the amputated or phantom right foot. Receives: 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. Receives: 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. Receives: Behavioral: direct observation |
| 4 | Experimental | Mental visualization with closed eyes of a sequence movements performed with the right amputated or phantom foot. Receives: Behavioral: mental visualization |
| 5 | Experimental | Mental visualization with closed eyes of a sequence movements performed with the left amputated or phantom foot. Receives: Behavioral: mental visualization |
| 6 | Experimental | Mental visualization with closed eyes of a sequence movements performed with the left and right amputated or phantom feet. Receives: Behavioral: mental visualization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant decrease in the level of phantom limb pain at 4 weeks.
Measured: 4 weeks
Secondary outcomes (1)
Significant decrease in the number and duration of daily phantom limb pain episodes at 4 weeks.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startDec 2007
- Primary completionAug 2014
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jack Tsao, MD, Walter Reed Army Medical Center
- Investigators
- Jack W Tsao, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639431
- Sponsor's protocol ID
- DCI P07-71044
- Status last verified
- Aug 2014
- First submitted
- 4 Dec 2007
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 564474Manchikanti L, Singh V. Managing phantom pain. Pain Physician. 2004 Jul;7(3):365-75.
PubMed 16858476Katz 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.
PubMed 2293143Jensen 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.
PubMed 6657285Cohen 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.
PubMed 2004259Elbert 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.
PubMed 7696611Kew 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.
PubMed 7884476Lotze 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.
PubMed 10448212Lotze 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.
PubMed 10511638Birbaumer 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.
PubMed 9204932Flor 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.
PubMed 7777055Grusser 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.
PubMed 11166112Ramachandran 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.
PubMed 1439826Lotze 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.
PubMed 11673327Ramachandran 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.
PubMed 8637922
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Efficacy of Direct Observation and Mental Visualization of Foot Movements to Treat Bilateral Lower Limb Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT00639431
- Acronym / sponsor ID
- DCI P07-71044
- Conditions
- Phantom Limb Pain
- Keywords
- phantom limb pain, limb amputation, Amputation, Phantom Limb, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- Dec 2007
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (estimated)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: direct observationDirect observation of a sequence of right foot movements performed by the experimenter while visualizing moving the amputated or phantom right foot. |
| 2 | Experimental | Behavioral: direct observationDirect observation of a sequence of left foot movements performed by the experimenter while visualizing moving the amputated or phantom left foot. |
| 3 | Experimental | Behavioral: direct observationDirect 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. |
| 4 | Experimental | Behavioral: mental visualizationMental visualization with closed eyes of a sequence movements performed with the right amputated or phantom foot. |
| 5 | Experimental | Behavioral: mental visualizationMental visualization with closed eyes of a sequence movements performed with the left amputated or phantom foot. |
| 6 | Experimental | Behavioral: mental visualizationMental visualization with closed eyes of a sequence movements performed with the left and right amputated or phantom feet. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| direct observationdirect observation of another person's foot moving | Behavioural | 1, 2, 3 |
| mental visualizationmentally imagining moving one's phantom foot/feet | Behavioural | 4, 5, 6 |
Primary outcome
Significant decrease in the level of phantom limb pain at 4 weeks.
Time frame: 4 weeks
1 secondary outcome
Significant decrease in the number and duration of daily phantom limb pain episodes at 4 weeks.
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
- Background: PubMed 564474Carlen 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.
- Background: PubMed 16858476Manchikanti L, Singh V. Managing phantom pain. Pain Physician. 2004 Jul;7(3):365-75.
- Background: PubMed 2293143Katz 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.
- Background: PubMed 6657285Jensen 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.
- Background: PubMed 2004259Cohen 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.
- Background: PubMed 7696611Elbert 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.
- Background: PubMed 7884476Kew 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.
- Background: PubMed 10448212Lotze 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.
- Background: PubMed 10511638Lotze 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.
- Background: PubMed 9204932Birbaumer 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.
- Background: PubMed 7777055Flor 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.
- Background: PubMed 11166112Grusser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack W Tsao, MD principal investigator
Walter Reed Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing direct observation and mental visualization in people with Phantom Limb Pain, run by Walter Reed Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jack W Tsao, MD (301-295-3643, jtsao@usuhs.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant decrease in the level of phantom limb pain at 4 weeks. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00639431, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014.