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Mirror Therapy in Complex Regional Pain Syndrome Type I

Primary Purpose

Complex Regional Pain Syndrome Type I

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mirror Therapy exercise
Sponsored by
University Hospital, Motol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndrome Type I

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - diagnosis of CRPS I based on the Budapest criteria Exclusion Criteria: failure to meet the diagnostic Budapest clinical criteria for CRPS I previous use of Mirror Therapy prior to the commencement of this study substantial difficulties in cooperation a significant change to the subjects' treatment regimen, outside of the study design

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group A - Mirror Therapy

    Group B - control period followed by Mirror Therapy

    Arm Description

    Group A carried out a ten-minute Mirror Therapy exercise daily, for a total duration of six weeks.

    Group B acted as a control group for six weeks (no Mirror Therapy) followed by six weeks of Mirror Therapy with the same characteristics as Group A.

    Outcomes

    Primary Outcome Measures

    Pain perception
    The participants in both groups made daily accounts of their pain level using 10 cm long visual analog scale (VAS) at rest as well as typical pain level during hand movement.
    Active Range of Motion
    Three attributes were measured: maximal active range of wrist flexion and extension (°) determined with goniometer measuring the angle between forearm and metacarpal bones
    Strength
    The outcome parameter is the highest pressure (bar) performed during one maximal grip.
    Dexterity
    Dexterity was evaluated by using a nine-hole PegBoard. The time taken to complete this task was measured.
    Volume of hand and forearm
    The volumetric measurements are based on the principle of water displacement.
    Temperature
    Temperature was measured bilaterally in the thenar area using an infrared thermometer.
    Health-related Quality of Life
    Determined using the European Quality of Life-5 Dimensions-3 Levels questionnaire. A range of 0-100% is used, where a higher score means a better outcome.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 12, 2023
    Last Updated
    October 20, 2023
    Sponsor
    University Hospital, Motol
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06100107
    Brief Title
    Mirror Therapy in Complex Regional Pain Syndrome Type I
    Official Title
    Mirror Visual Feedback as Therapeutic Modality in Unilateral Upper Extremity Complex Regional Pain Syndrome Type I
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    September 9, 2013 (Actual)
    Primary Completion Date
    September 30, 2015 (Actual)
    Study Completion Date
    January 15, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital, Motol

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim is to evaluate the efficacy of Mirror Therapy on pain reduction and hand function in subjects with unilateral upper extremity Complex Regional Pain Syndrome Type I.
    Detailed Description
    Subjects were randomly divided into two groups. Group A carried out a ten-minute Mirror Therapy exercise daily, for a total duration of six weeks. Group B acted as a control group for six weeks followed by six weeks of Mirror Therapy with the same characteristics as Group A. Upper extremity active range of motion, strength, dexterity, limb volume, right-left temperature difference, and health-related quality of life were evaluated before and after each period. Daily records on the visual analogue scale were used for pain evaluation. Effectiveness was calculated using mixed-effects modelling for between-group comparisons and within-group variability and identifying significant predictors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Complex Regional Pain Syndrome Type I

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Specifically, the study employs a half cross-over design. Group A begins with the intervention, while Group B starts with a control period of equal length, followed by the intervention. This design facilitates comparisons both between the groups and within Group B across the two periods.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A - Mirror Therapy
    Arm Type
    Experimental
    Arm Description
    Group A carried out a ten-minute Mirror Therapy exercise daily, for a total duration of six weeks.
    Arm Title
    Group B - control period followed by Mirror Therapy
    Arm Type
    Experimental
    Arm Description
    Group B acted as a control group for six weeks (no Mirror Therapy) followed by six weeks of Mirror Therapy with the same characteristics as Group A.
    Intervention Type
    Other
    Intervention Name(s)
    Mirror Therapy exercise
    Other Intervention Name(s)
    Mirror visual feedback exercise
    Intervention Description
    Mirror Therapy for the upper limb involves the use of a mirror to create a reflected image of the unaffected arm, making it appear as if both arms are moving symmetrically. During the therapy, the patient places their affected arm behind the mirror and their unaffected arm in front. While focusing on the mirror reflection, the patient performs various movements with the unaffected arm, giving the illusion that the affected arm is moving normally.
    Primary Outcome Measure Information:
    Title
    Pain perception
    Description
    The participants in both groups made daily accounts of their pain level using 10 cm long visual analog scale (VAS) at rest as well as typical pain level during hand movement.
    Time Frame
    Recordings performed every day from day 0 to day 42 (Group A) and from day 0 to day 84 (Group B); Follow-up on day 72 (Group A) and day 114 (Group B).
    Title
    Active Range of Motion
    Description
    Three attributes were measured: maximal active range of wrist flexion and extension (°) determined with goniometer measuring the angle between forearm and metacarpal bones
    Time Frame
    On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
    Title
    Strength
    Description
    The outcome parameter is the highest pressure (bar) performed during one maximal grip.
    Time Frame
    On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
    Title
    Dexterity
    Description
    Dexterity was evaluated by using a nine-hole PegBoard. The time taken to complete this task was measured.
    Time Frame
    On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
    Title
    Volume of hand and forearm
    Description
    The volumetric measurements are based on the principle of water displacement.
    Time Frame
    On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
    Title
    Temperature
    Description
    Temperature was measured bilaterally in the thenar area using an infrared thermometer.
    Time Frame
    On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
    Title
    Health-related Quality of Life
    Description
    Determined using the European Quality of Life-5 Dimensions-3 Levels questionnaire. A range of 0-100% is used, where a higher score means a better outcome.
    Time Frame
    On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - diagnosis of CRPS I based on the Budapest criteria Exclusion Criteria: failure to meet the diagnostic Budapest clinical criteria for CRPS I previous use of Mirror Therapy prior to the commencement of this study substantial difficulties in cooperation a significant change to the subjects' treatment regimen, outside of the study design

    12. IPD Sharing Statement

    Learn more about this trial

    Mirror Therapy in Complex Regional Pain Syndrome Type I

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