Mirror Therapy in Complex Regional Pain Syndrome Type I

Not Applicable

Completed

• Conditions: Complex Regional Pain Syndrome Type I
• Interventions: Other: Mirror Therapy exercise

• Registration Number: NCT06100107
• Lead Sponsor: University Hospital, Motol

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.

Study Timeline

• Study Start: 2013-09-09
• Primary Completion: 2015-09-30
• Study Completion: 2016-01-15
• Status Verified: 2023-10
• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-20
• Last Update Submitted: 2023-10-20
• Study First Posted: 2023-10-25
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B - control period followed by Mirror Therapy	Mirror Therapy exercise	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.
Group A - Mirror Therapy	Mirror Therapy exercise	Group A carried out a ten-minute Mirror Therapy exercise daily, for a total duration of six weeks.

Primary Outcome Measures

Name	Time	Method
Pain perception	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	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	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	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	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	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	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.