Home-based Self-delivered Mirror Therapy for Phantom Limb Pain
Primary Purpose
Phantom Limb Pain
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mirror Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Phantom Limb Pain focused on measuring Phantom limb pain, Mirror therapy, amputation, Limb loss, treatment
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Self-delivered mirror therapy
Arm Description
All participants were directed to self-deliver mirror therapy for 20 minutes per day.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Outcome will be determined by measuring changes in pain-related anxiety levels (baseline to one month) as measured by the Pain Anxiety Symptom Scale.
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
Full Information
NCT ID
NCT00827294
First Posted
January 20, 2009
Last Updated
October 10, 2019
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT00827294
Brief Title
Home-based Self-delivered Mirror Therapy for Phantom Limb Pain
Official Title
A Pilot Study of Self-delivered Home-based Mirror Therapy for Phantom Limb Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
a. Specific Aims:
1. 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.
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, Mirror therapy, amputation, Limb loss, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-delivered mirror therapy
Arm Type
Experimental
Arm Description
All participants were directed to self-deliver mirror therapy for 20 minutes per day.
Intervention Type
Behavioral
Intervention Name(s)
Mirror Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in self-reported pain assessed using the Numeric Rating Scale (NRS)
Description
Numeric Rating Scale (NRS) ranges from score of 0 to 10, where 0=no pain and 10=worst possible pain
Time Frame
month 1
Secondary Outcome Measure Information:
Title
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
Title
Change in self-reported pain assessed using the Numeric Rating Scale (NRS)
Description
Numeric Rating Scale (NRS) ranges from score of 0 to 10, where 0=no pain and 10=worst possible pain
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth D Darnall, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19096290
Citation
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.
Results Reference
background
Learn more about this trial
Home-based Self-delivered Mirror Therapy for Phantom Limb Pain
We'll reach out to this number within 24 hrs