Phantom Limb PainEarly Phase 1NCT00827294
Home-based Self-delivered Mirror Therapy for Phantom Limb Pain
A Early Phase 1 study testing Mirror Therapy in people with Phantom Limb Pain, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The goals of the study are to determine whether self-delivered, home-based mirror therapy decreases the frequency and intensity of phantom limb pain and improves mood and physical function in persons with phantom limb pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- Mirror Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2010
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Unilateral amputation of upper or lower limb
- At least 1 month after surgical healing
- English-speaking (since not all study materials have been translated)
Who cannot join
- History of brain injury or cognitive difficulties
- Severe mental illness that impairs cognition or function
- Suicidal ideation
- Current substance abuse or dependence
- Amputation related to diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Pilot Study of Self-delivered Home-based Mirror Therapy for Phantom Limb Pain
The goals of the study are to determine whether self-delivered, home-based mirror therapy decreases the frequency and intensity of phantom limb pain and improves mood and physical function in persons with phantom limb pain.
The investigators hypothesize that self-delivered home-based mirror therapy will significantly decrease phantom pain intensity, will improve mood, and will improve function at one-month follow-up.
Read the detailed description
Background: Incidence of acquired amputation is increasing due to military conflict injuries and the increasing prevalence of diabetes-related peripheral vascular disease. Phantom pain is a commonly experienced comorbid condition. Existing treatments have shown mixed success in treating phantom pain. Mirror therapy has been shown to be an effective treatment when used under the guidance of a therapist in a clinical setting. There is anecdotal evidence that home-based therapy may also be effective.
Objective: Determine whether self-delivered, home-based mirror therapy decreases the frequency and intensity of phantom limb pain and improves the psychological status and physical function of amputees with phantom limb pain.
Design: Single group trial comparing pre- and post-treatment measures. Setting and Subjects: Up to 50 subjects with unilateral limb amputation and phantom limb pain will be recruited from the VA and OHSU hospital clinics. The investigators will also be passively recruiting through Kaiser Permanente Northwest (KPNW). The Pain Clinic and Physical Therapy Department at KPNW will post flyers in their waiting and patient areas for potential subjects to see. Interested patients will then self-refer to the study. Flyers will also be sent to regional amputee support groups in the Northwest and Southern California for distribution to their members. Certain inclusion and exclusion criteria must be met.
Intervention: Subjects will receive an information sheet and instruction in performing mirror therapy at home.
Measurements: Subjects will complete standard questionnaires designed to measure phantom pain level, function, depressive symptoms, pain-related anxiety, catastrophizing, and sleep quality. Subjects will also be asked about current use of pain medications and to keep a daily diary to keep track of treatment sessions.
Analysis: For the primary analysis comparing difference between baseline and 1 month post treatment, a paired t-test will be used to compare continuous variables (pain, depressive symptoms, pain-related anxiety level, sleep quality, pain catastrophizing, function) and for categorical outcomes (use of pain medications), McNemar's test or test of symmetry will be used. To investigate whether treatment gains for pain, depressive symptoms, pain-related anxiety level, sleep quality, pain catastrophizing, or function are sustained over time, a linear model will be used with controlling for correlation within repeated measures.
- Specific Aims:
- Primary Aim and Hypothesis: Primary Aim: Determine whether self-delivered, home-based mirror therapy decreases the intensity of phantom limb pain at one month follow-up. The primary outcome measure will be average pain intensity (the Brief Pain Inventory-short form; BPI-sf).
Hypothesis for Primary Aim #1: Amputees who practice mirror therapy at home will experience a decrease in the intensity of their phantom limb pain as measured by the Brief Pain Inventory-short form (BPI-sf) at one month follow-up.
- Conditions
- Phantom Limb Pain
- Being tested
- Mirror Therapy
- Keywords
- Phantom limb pain, Mirror therapy, amputation, Limb loss, treatment
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror TherapyBehavioural
The study is an uncontrolled pilot. Subjects receive instruction in performing mirror therapy at home, either in person or by viewing a DVD. Subjects will be asked to practice mirror therapy 20 minutes daily. Subjects will complete questionnaires for phantom pain, function, depressive symptoms, anxiety, catastrophizing, and sleep quality at baseline and post treatment at 1 month, 2 months, 3 months, and 6 months. Subjects will keep a diary of their practice and study staff will check in with subjects weekly for the first month, and monthly thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Self-delivered mirror therapy | Experimental | All participants were directed to self-deliver mirror therapy for 20 minutes per day. Receives: Behavioral: Mirror Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported pain assessed using the Numeric Rating Scale (NRS)
Numeric Rating Scale (NRS) ranges from score of 0 to 10, where 0=no pain and 10=worst possible pain
Measured: month 1
Secondary outcomes (2)
Outcome will be determined by measuring changes in pain-related anxiety levels (baseline to one month) as measured by the Pain Anxiety Symptom Scale.
Measured: Primary interested in outcome at month 1
Change in self-reported pain assessed using the Numeric Rating Scale (NRS)
Numeric Rating Scale (NRS) ranges from score of 0 to 10, where 0=no pain and 10=worst possible pain
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Darnall, PhD, Oregon Health and Science University
- Investigators
- Beth D Darnall, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827294
- Sponsor's protocol ID
- 4925 Mirror Therapy
- Other IDs
- 5K12HD04348807
- Status last verified
- Oct 2019
- First submitted
- 20 Jan 2009
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Darnall BD. Self-delivered home-based mirror therapy for lower limb phantom pain. Am J Phys Med Rehabil. 2009 Jan;88(1):78-81. doi: 10.1097/PHM.0b013e318191105b.
PubMed 19096290
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Self-delivered Home-based Mirror Therapy for Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT00827294
- Acronym / sponsor ID
- 4925 Mirror Therapy
- Conditions
- Phantom Limb Pain
- Keywords
- Phantom limb pain, Mirror therapy, amputation, Limb loss, treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 22 Jan 2009 (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.
The goals of the study are to determine whether self-delivered, home-based mirror therapy decreases the frequency and intensity of phantom limb pain and improves mood and physical function in persons with phantom limb pain.
The investigators hypothesize that self-delivered home-based mirror therapy will significantly decrease phantom pain intensity, will improve mood, and will improve function at one-month follow-up.
Detailed description
Background: Incidence of acquired amputation is increasing due to military conflict injuries and the increasing prevalence of diabetes-related peripheral vascular disease. Phantom pain is a commonly experienced comorbid condition. Existing treatments have shown mixed success in treating phantom pain. Mirror therapy has been shown to be an effective treatment when used under the guidance of a therapist in a clinical setting. There is anecdotal evidence that home-based therapy may also be effective.
Objective: Determine whether self-delivered, home-based mirror therapy decreases the frequency and intensity of phantom limb pain and improves the psychological status and physical function of amputees with phantom limb pain.
Design: Single group trial comparing pre- and post-treatment measures. Setting and Subjects: Up to 50 subjects with unilateral limb amputation and phantom limb pain will be recruited from the VA and OHSU hospital clinics. The investigators will also be passively recruiting through Kaiser Permanente Northwest (KPNW). The Pain Clinic and Physical Therapy Department at KPNW will post flyers in their waiting and patient areas for potential subjects to see. Interested patients will then self-refer to the study. Flyers will also be sent to regional amputee support groups in the Northwest and Southern California for distribution to their members. Certain inclusion and exclusion criteria must be met.
Intervention: Subjects will receive an information sheet and instruction in performing mirror therapy at home.
Measurements: Subjects will complete standard questionnaires designed to measure phantom pain level, function, depressive symptoms, pain-related anxiety, catastrophizing, and sleep quality. Subjects will also be asked about current use of pain medications and to keep a daily diary to keep track of treatment sessions.
Analysis: For the primary analysis comparing difference between baseline and 1 month post treatment, a paired t-test will be used to compare continuous variables (pain, depressive symptoms, pain-related anxiety level, sleep quality, pain catastrophizing, function) and for categorical outcomes (use of pain medications), McNemar's test or test of symmetry will be used. To investigate whether treatment gains for pain, depressive symptoms, pain-related anxiety level, sleep quality, pain catastrophizing, or function are sustained over time, a linear model will be used with controlling for correlation within repeated measures.
- Specific Aims:
- Primary Aim and Hypothesis: Primary Aim: Determine whether self-delivered, home-based mirror therapy decreases the intensity of phantom limb pain at one month follow-up. The primary outcome measure will be average pain intensity (the Brief Pain Inventory-short form; BPI-sf).
Hypothesis for Primary Aim #1: Amputees who practice mirror therapy at home will experience a decrease in the intensity of their phantom limb pain as measured by the Brief Pain Inventory-short form (BPI-sf) at one month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-delivered mirror therapy | Experimental | Behavioral: Mirror TherapyAll participants were directed to self-deliver mirror therapy for 20 minutes per day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years
- Unilateral amputation of upper or lower limb
- At least 1 month after surgical healing
- English-speaking (since not all study materials have been translated)
Key exclusion criteria (5 listed)
- History of brain injury or cognitive difficulties
- Severe mental illness that impairs cognition or function
- Suicidal ideation
- Current substance abuse or dependence
- Amputation related to diabetes
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 |
|---|---|---|
| Mirror TherapyThe study is an uncontrolled pilot. Subjects receive instruction in performing mirror therapy at home, either in person or by viewing a DVD. Subjects will be asked to practice mirror therapy 20 minutes daily. Subjects will complete questionnaires for phantom pain, function, depressive symptoms, anxiety, catastrophizing, and sleep quality at baseline and post treatment at 1 month, 2 months, 3 months, and 6 months. Subjects will keep a diary of their practice and study staff will check in with subjects weekly for the first month, and monthly thereafter. | Behavioural | Self-delivered mirror therapy |
Primary outcome
Change in self-reported pain assessed using the Numeric Rating Scale (NRS)
Time frame: month 1
Numeric Rating Scale (NRS) ranges from score of 0 to 10, where 0=no pain and 10=worst possible pain
2 secondary outcomes
Outcome will be determined by measuring changes in pain-related anxiety levels (baseline to one month) as measured by the Pain Anxiety Symptom Scale.
Time frame: Primary interested in outcome at month 1
Change in self-reported pain assessed using the Numeric Rating Scale (NRS)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Background: PubMed 19096290Darnall BD. Self-delivered home-based mirror therapy for lower limb phantom pain. Am J Phys Med Rehabil. 2009 Jan;88(1):78-81. doi: 10.1097/PHM.0b013e318191105b.
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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.
Beth D Darnall, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mirror Therapy in people with Phantom Limb Pain, run by Oregon Health and Science University 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 4 inclusion and 5 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 15 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in self-reported pain assessed using the Numeric Rating Scale (NRS) (time frame: month 1). 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 NCT00827294, which also lists 1 linked publication.
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 15 Oct 2019.