Phantom LimbNCT00731614
Cognitive Behavior Therapy (CBT) and Mirror Training for Phantom Limb Pain
A study testing Cognitive Behavioral Therapy and Mirror Retraining, Supportive therapy and Mirror retraining in people with Phantom Limb, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
The goal of this study is to test whether a combination of cognitive-behavior therapy and mirror training reduces phantom limb pain for veterans with amputations. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Phantom Limb
- What is being tested?
- Cognitive Behavioral Therapy and Mirror Retraining, Supportive therapy and Mirror retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2008to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (21or over)
- unilateral amputation at or above wrist or ankle
- phantom limb pain occurring at least weekly
- living within 50 miles of a recruitment site (San Diego, San Francisco, or Long Beach VAs).
- able to read and speak English
Who cannot join
- Current alcohol or drug dependence
- active psychosis
- medical problems that preclude participation
- current enrollment in behavioral pain management
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Medical Center, Long Beach
Long Beach, California, 90822
VA San Diego Healthcare System, San Diego
San Diego, California, 92161
VA Medical Center, San Francisco
San Francisco, California, 94121
About this study
Official title: Psychosocial and Visual Feedback Intervention for Phantom Limb Pain
The goal of this study is to test whether a combination of cognitive-behavior therapy and mirror training reduces phantom limb pain for veterans with amputations.
Read the detailed description
The proposed study is a randomized controlled trial designed to test whether CBT plus mirror therapy (CBT+MT) is superior to supportive care (SC) for treatment of phantom limb pain (PLP) in amputees. The primary hypothesis is that CBT+ MT will lead to significantly greater reductions in PLP compared to SC. Secondary hypotheses will test whether CBT+MT also leads to significantly greater improvements in psychiatric symptoms, functioning, and quality of life than SC.
Eighty veterans from the San Diego VA Healthcare System (SDVAHS) will be recruited. All veterans will have a unilateral upper or lower limb amputation. All participants will complete an intake assessment prior to treatment randomization. The assessment will include measures of pain (Phantom Limb Pain Questionnaire, Descriptive Differential Scale, McGill Pain Questionnaire) psychiatric symptoms (Patient Health Questionnaire, Posttraumatic Stress disorder Checklist), psychiatric diagnosis (Mini-International Neuropsychiatric Interview) and functioning (Trinity Amputation and Prosthesis Experiences Scale, Short Form-36). Participants will then randomized to either CBT+MT or SC. Participants will complete pain and mood assessments weekly during treatment, and be retested on the full assessment battery at the end of treatment and 12 and 24 weeks posttreatment.
The CBT+MT intervention will consist of 8 individual sessions of CBT, including psychoeducation, cognitive restructuring, relaxation training, and acceptance techniques. Participants in the CBT+MT condition will also learn to use a mirror apparatus to reduce PLP, and will receive a set of mirrors to use at home. The SC treatment will consist of the therapist meeting with the patient and using listening and reflection skills to discuss the patient's pain. The SC condition will have no pain education or skills training component.
Data analyses will use a repeated-measures ANOVA approach to test whether the two conditions differ on change in the primary measure (Phantom Limb Pain Questionnaire) as well as in other pain, psychiatric symptom, functioning and quality of life measures. Exploratory analyses will test whether patient variables and amputation characteristics predict treatment outcomes.
- Conditions
- Phantom Limb
- Being tested
- Cognitive Behavioral Therapy and Mirror Retraining, Supportive therapy, Mirror retraining
- Keywords
- cognitive therapy, mirror training, nondirective therapy, veterans, amputees
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy and Mirror RetrainingBehavioural
Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.
Supportive therapyBehavioural
Also called Non-directive therapy
Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
Mirror retrainingBehavioural
Also called Mirror box training
Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Cognitive Behavior Therapy + mirror retraining Receives: Behavioral: Cognitive Behavioral Therapy and Mirror Retraining; Behavioral: Mirror retraining |
| Arm 2 | Active comparator | Supportive psychotherapy Receives: Behavioral: Supportive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phantom Limb Pain Questionnaire
The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable)
Measured: Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.
Secondary outcomes (1)
Short Form-12 (SF-12)
the Short Form-12 (SF-12) is a standardized self-report questionnaire that assesses mental and physical functioning. The Physical Component Summary (PCS) is scored on a scale from 0-100, with higher scores representing better reported health.
Measured: Baseline, end of treatment (8 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Phantom LimbStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John R. McQuaid, PhD MS BA, Principal investigator, VA Medical Center, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731614
- Sponsor's protocol ID
- F6441-R
- Other IDs
- UCSD IRB 080898
- Status last verified
- Oct 2019
- First submitted
- 5 Aug 2008
- Last updated
- 29 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial and Visual Feedback Intervention for Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT00731614
- Acronym / sponsor ID
- F6441-R
- Conditions
- Phantom Limb
- Keywords
- cognitive therapy, mirror training, nondirective therapy, veterans, amputees
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Nov 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Posted 18 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test whether a combination of cognitive-behavior therapy and mirror training reduces phantom limb pain for veterans with amputations.
Detailed description
The proposed study is a randomized controlled trial designed to test whether CBT plus mirror therapy (CBT+MT) is superior to supportive care (SC) for treatment of phantom limb pain (PLP) in amputees. The primary hypothesis is that CBT+ MT will lead to significantly greater reductions in PLP compared to SC. Secondary hypotheses will test whether CBT+MT also leads to significantly greater improvements in psychiatric symptoms, functioning, and quality of life than SC.
Eighty veterans from the San Diego VA Healthcare System (SDVAHS) will be recruited. All veterans will have a unilateral upper or lower limb amputation. All participants will complete an intake assessment prior to treatment randomization. The assessment will include measures of pain (Phantom Limb Pain Questionnaire, Descriptive Differential Scale, McGill Pain Questionnaire) psychiatric symptoms (Patient Health Questionnaire, Posttraumatic Stress disorder Checklist), psychiatric diagnosis (Mini-International Neuropsychiatric Interview) and functioning (Trinity Amputation and Prosthesis Experiences Scale, Short Form-36). Participants will then randomized to either CBT+MT or SC. Participants will complete pain and mood assessments weekly during treatment, and be retested on the full assessment battery at the end of treatment and 12 and 24 weeks posttreatment.
The CBT+MT intervention will consist of 8 individual sessions of CBT, including psychoeducation, cognitive restructuring, relaxation training, and acceptance techniques. Participants in the CBT+MT condition will also learn to use a mirror apparatus to reduce PLP, and will receive a set of mirrors to use at home. The SC treatment will consist of the therapist meeting with the patient and using listening and reflection skills to discuss the patient's pain. The SC condition will have no pain education or skills training component.
Data analyses will use a repeated-measures ANOVA approach to test whether the two conditions differ on change in the primary measure (Phantom Limb Pain Questionnaire) as well as in other pain, psychiatric symptom, functioning and quality of life measures. Exploratory analyses will test whether patient variables and amputation characteristics predict treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Cognitive Behavioral Therapy and Mirror Retraining, Behavioral: Mirror retrainingCognitive Behavior Therapy + mirror retraining |
| Arm 2 | Active comparator | Behavioral: Supportive therapySupportive psychotherapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (21or over)
- unilateral amputation at or above wrist or ankle
- phantom limb pain occurring at least weekly
- living within 50 miles of a recruitment site (San Diego, San Francisco, or Long Beach VAs).
- able to read and speak English
Key exclusion criteria (4 listed)
- Current alcohol or drug dependence
- active psychosis
- medical problems that preclude participation
- current enrollment in behavioral pain management
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 |
|---|---|---|
| Cognitive Behavioral Therapy and Mirror RetrainingCognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain. | Behavioural | Arm 1 |
| Supportive therapyAlso: Non-directive therapyNon-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions. | Behavioural | Arm 2 |
| Mirror retrainingAlso: Mirror box trainingUse of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain | Behavioural | Arm 1 |
Primary outcome
Phantom Limb Pain Questionnaire
Time frame: Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.
The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable)
1 secondary outcome
Short Form-12 (SF-12)
Time frame: Baseline, end of treatment (8 weeks after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John R. McQuaid, PhD MS BA principal investigator
VA Medical Center, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Mirror Retraining, Supportive therapy and Mirror retraining in people with Phantom Limb, run by VA Office of Research and Development at 3 sites 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 18 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phantom Limb Pain Questionnaire (time frame: Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2019.