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Telerehabilitation Using Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation.

Primary Purpose

Phantom Limb Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical/Occupational therapy
Sponsored by
Zuyd University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Phantom Limb Pain focused on measuring Telerehabilitation, mirror therapy, phantom limb pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Lower limb amputation
  2. At least since one week constant or intermittent phantom limb pain (PLP) with an average intensity of at least score 3 on the 11-point NRS and a minimum frequency of one episode of PLP per week.
  3. Sufficient cognitive, communicative and motor functions to be able to use the telerehabilitation service, to concentrate for at least 15 minutes on the mirror image and to follow instructions and questionnaires; this is based on clinical judgment of recruiting physicians or therapists.

    Exclusion Criteria:

  4. Duration of inpatient rehabilitation not long enough to ensure the 4-week clinical intervention phase.
  5. Bilateral amputation, severe co-morbidity (e.g. stroke) or pain affecting the intact limb; this prevents engagement in the prescribed exercise programs of the study.
  6. Severe psychiatric disorders that preclude patients from participating in the trial.
  7. Intensive course of mirror therapy in the past (> 6 treatments during the last three months).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Software Supported Mirror Therapy

    Traditional mirror therapy

    Sensomotor exercises without mirror

    Arm Description

    First experimental condition Physical/Occupational Therapy

    Second experimental condition Physical/Occupational Therapy

    Control condition Physical/Occupational Therapy

    Outcomes

    Primary Outcome Measures

    Change in average intensity of phantom limb pain
    Measurement instrument: 11-point NRS
    Change in frequency of phantom limb pain
    Change in duration of phantom limb pain

    Secondary Outcome Measures

    Change in pain related limitations in daily activities
    Measurement instrument: PDI, PSFS
    Change in pain specific self-efficacy
    Measurement instrument: Pain specific self-efficacy scale
    Change in quality of life
    Measurement instrument: EQ-5D-5L
    Change in global perceived effect
    Measurement instrument: GPE scale
    Change in dimensions of phantom limb pain
    Measurement instrument: Neuropathic Pain Symptom Inventory (NPSI)

    Full Information

    First Posted
    February 3, 2014
    Last Updated
    February 27, 2014
    Sponsor
    Zuyd University of Applied Sciences
    Collaborators
    Maastricht University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02076490
    Brief Title
    Telerehabilitation Using Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation.
    Official Title
    The PACT Trial - PAtient Centered Telerehabilitation: Effectiveness of Software-supported and Traditional Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation: Design of a Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    May 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Zuyd University of Applied Sciences
    Collaborators
    Maastricht University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The overall aim of this randomized controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and daily activities compared to traditional mirror therapy and sensomotor exercises without a mirror in patients following lower limb amputation.
    Detailed Description
    Up to 75% of patients after amputation of an arm or leg suffer from chronic phantom limb pain that still is perceived in the missing limb, leading to limitations in daily activities and quality of life. The treatment of phantom limb pain is still challenging. Despite many different pharmacological interventions, the outcomes on the longer-term are in many cases not satisfying. Alternative, non-pharmacological interventions, such as mirror therapy, are gaining increased recognition in the treatment of phantom limb pain. In this context, telerehabilitation plays an important role to support long-term self-management and autonomy of these patients. In the developmental phase of the project, a user-centred design is applied. Patients as well as physical and occupational therapists are interviewed concerning their preferences and needs with respect to the design and content of the telerehabilitation. Additionally, two focus groups with each five participants will be conducted. Subsequently, a prototype of the telerehabilitation will be developed based on user preferences, available evidence, expert opinion and already existing systems. This prototype will be tested on its usability and technical performance in phase three using the thinking-aloud-method and data logging. Accordingly, a multicenter, randomized controlled trial will be conducted to evaluate the cost-effectiveness of the telerehabilitation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Phantom Limb Pain
    Keywords
    Telerehabilitation, mirror therapy, phantom limb pain

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    105 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Software Supported Mirror Therapy
    Arm Type
    Experimental
    Arm Description
    First experimental condition Physical/Occupational Therapy
    Arm Title
    Traditional mirror therapy
    Arm Type
    Experimental
    Arm Description
    Second experimental condition Physical/Occupational Therapy
    Arm Title
    Sensomotor exercises without mirror
    Arm Type
    Active Comparator
    Arm Description
    Control condition Physical/Occupational Therapy
    Intervention Type
    Other
    Intervention Name(s)
    Physical/Occupational therapy
    Intervention Description
    At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.
    Primary Outcome Measure Information:
    Title
    Change in average intensity of phantom limb pain
    Description
    Measurement instrument: 11-point NRS
    Time Frame
    At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
    Title
    Change in frequency of phantom limb pain
    Time Frame
    At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
    Title
    Change in duration of phantom limb pain
    Time Frame
    At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
    Secondary Outcome Measure Information:
    Title
    Change in pain related limitations in daily activities
    Description
    Measurement instrument: PDI, PSFS
    Time Frame
    At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
    Title
    Change in pain specific self-efficacy
    Description
    Measurement instrument: Pain specific self-efficacy scale
    Time Frame
    At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
    Title
    Change in quality of life
    Description
    Measurement instrument: EQ-5D-5L
    Time Frame
    At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
    Title
    Change in global perceived effect
    Description
    Measurement instrument: GPE scale
    Time Frame
    At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
    Title
    Change in dimensions of phantom limb pain
    Description
    Measurement instrument: Neuropathic Pain Symptom Inventory (NPSI)
    Time Frame
    At baseline, 4 and 6 weeks following baseline and at 6 months follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Lower limb amputation At least since one week constant or intermittent phantom limb pain (PLP) with an average intensity of at least score 3 on the 11-point NRS and a minimum frequency of one episode of PLP per week. Sufficient cognitive, communicative and motor functions to be able to use the telerehabilitation service, to concentrate for at least 15 minutes on the mirror image and to follow instructions and questionnaires; this is based on clinical judgment of recruiting physicians or therapists. Exclusion Criteria: Duration of inpatient rehabilitation not long enough to ensure the 4-week clinical intervention phase. Bilateral amputation, severe co-morbidity (e.g. stroke) or pain affecting the intact limb; this prevents engagement in the prescribed exercise programs of the study. Severe psychiatric disorders that preclude patients from participating in the trial. Intensive course of mirror therapy in the past (> 6 treatments during the last three months).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rob J Smeets, Prof., Dr.
    Organizational Affiliation
    Research School CAPHRI, Maastricht University, Maastricht, The Netherlands
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25439709
    Citation
    Rothgangel AS, Braun S, Schulz RJ, Kraemer M, de Witte L, Beurskens A, Smeets RJ. The PACT trial: PAtient Centered Telerehabilitation: effectiveness of software-supported and traditional mirror therapy in patients with phantom limb pain following lower limb amputation: protocol of a multicentre randomised controlled trial. J Physiother. 2015 Jan;61(1):42; discussion 42. doi: 10.1016/j.jphys.2014.08.006. Epub 2014 Oct 16.
    Results Reference
    derived

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    Telerehabilitation Using Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation.

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