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Completed

NCT Number: NCT06100107

Mirror Therapy in Complex Regional Pain Syndrome Type I

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.

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Key information

Conditions

Complex Regional Pain Syndrome Type I Autonomic Nervous System Diseases Complex Regional Pain Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirror Therapy exercise

Other

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.

Other names: Mirror visual feedback exercise

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Motol

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Oct 25, 2023
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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