Mirror Therapy in Complex Regional Pain Syndrome Type I

Mirror Visual Feedback as Therapeutic Modality in Unilateral Upper Extremity 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.

Study Overview

• Status: Completed
• Conditions: Complex Regional Pain Syndrome Type I
• Intervention / Treatment: Other: Mirror Therapy exercise

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A - Mirror Therapy; Group A carried out a ten-minute Mirror Therapy exercise daily, for a total duration of six weeks.	Other: Mirror Therapy exercise; 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
Experimental: Group B - control period followed by Mirror Therapy; 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.	Other: Mirror Therapy exercise; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).
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	On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Strength	The outcome parameter is the highest pressure (bar) performed during one maximal grip.	On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Dexterity	Dexterity was evaluated by using a nine-hole PegBoard. The time taken to complete this task was measured.	On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Volume of hand and forearm	The volumetric measurements are based on the principle of water displacement.	On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Temperature	Temperature was measured bilaterally in the thenar area using an infrared thermometer.	On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
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.	On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)

Collaborators and Investigators

• Sponsor: University Hospital, Motol

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2013
• Primary Completion (Actual): September 30, 2015
• Study Completion (Actual): January 15, 2016

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Somatoform Disorders
• Other Study ID Numbers: EK-1288/14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No