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Clinical Trials/NCT06100107
NCT06100107
Completed
Not Applicable

Mirror Visual Feedback as Therapeutic Modality in Unilateral Upper Extremity Complex Regional Pain Syndrome Type I

University Hospital, Motol0 sites27 target enrollmentSeptember 9, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complex Regional Pain Syndrome Type I
Sponsor
University Hospital, Motol
Enrollment
27
Primary Endpoint
Pain perception
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 9, 2013
End Date
January 15, 2016
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
University Hospital, Motol
Responsible Party
Principal Investigator
Principal Investigator

Rudolf Cerny

Senior Investigator

University Hospital, Motol

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

Outcomes

Primary Outcomes

Pain perception

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).

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.

Dexterity

Time Frame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)

Dexterity was evaluated by using a nine-hole PegBoard. The time taken to complete this task was measured.

Health-related Quality of Life

Time Frame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)

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.

Active Range of Motion

Time Frame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)

Three attributes were measured: maximal active range of wrist flexion and extension (°) determined with goniometer measuring the angle between forearm and metacarpal bones

Strength

Time Frame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)

The outcome parameter is the highest pressure (bar) performed during one maximal grip.

Volume of hand and forearm

Time Frame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)

The volumetric measurements are based on the principle of water displacement.

Temperature

Time Frame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)

Temperature was measured bilaterally in the thenar area using an infrared thermometer.

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