NCT00827294

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

January 20, 2009

Last Update Submit

October 10, 2019

Conditions

Phantom Limb Pain

Keywords

Phantom limb painMirror therapyamputationLimb losstreatment

Outcome Measures

Primary Outcomes (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

    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.

    Primary interested in outcome at month 1

  • Change in self-reported pain assessed using the Numeric Rating Scale (NRS)

    2 months

Study Arms (1)

Self-delivered mirror therapy

EXPERIMENTAL

All participants were directed to self-deliver mirror therapy for 20 minutes per day.

Behavioral: Mirror Therapy

Interventions

Mirror TherapyBEHAVIORAL

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.

Self-delivered mirror therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • 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.

    PMID: 19096290BACKGROUND

MeSH Terms

Conditions

Phantom Limb

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPain, PostoperativePostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsPain

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Beth D Darnall, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

January 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

October 15, 2019

Record last verified: 2019-10

Locations

US(1)