Mirror Therapy in Complex Regional Pain Syndrome Type I

Complex Regional Pain Syndrome Type I Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06100107
• Other study ID #: EK-1288/14
• Status: Completed
• Phase: N/A
• Start date: September 9, 2013
• Est. completion date: January 15, 2016

Study information

• Verified date: October 2023
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 15, 2016
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome Type I
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)