Home-based Self-delivered Mirror Therapy for Phantom Limb Pain
Condition: Phantom Limb Pain
MeSH terms: Phantom Limb
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Mirror Therapy
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phantom limb pain; Mirror therapy; amputation; Limb loss; treatment