Mirror Therapy in Complex Regional Pain Syndrome Type I

Sponsor

University Hospital, Motol (Other)

Overall Status

Completed

CT.gov ID

NCT06100107

Collaborator

(none)

Enrollment

Arms

28.2

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Complex Regional Pain Syndrome Type I	Other: Mirror Therapy exercise	N/A

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

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 Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 9, 2013

Actual Primary Completion Date :

Sep 30, 2015

Actual Study Completion Date :

Jan 15, 2016

Arms and Interventions

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

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

Other Names:

Mirror visual feedback exercise

Outcome Measures

Primary Outcome Measures

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.
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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Motol

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rudolf Cerny, Senior Investigator, University Hospital, Motol

ClinicalTrials.gov Identifier:

NCT06100107

Other Study ID Numbers:

EK-1288/14

First Posted:

Oct 25, 2023

Last Update Posted:

Oct 25, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Complex Regional Pain Syndromes

Reflex Sympathetic Dystrophy

Syndrome

Somatoform Disorders

Study Results

No Results Posted as of Oct 25, 2023