Mirror Therapy in Complex Regional Pain Syndrome Type I

NCT06100107 | Completed

• 1 other identifier: EK-1288/14
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Complex Regional Pain Syndrome Type I

Outcome Measures

Primary Outcomes (7)

• 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)

Study Arms (2)

Group A - Mirror Therapy

EXPERIMENTAL

Group A carried out a ten-minute Mirror Therapy exercise daily, for a total duration of six weeks.

Other: Mirror Therapy exercise

Group B - control period followed by Mirror Therapy

EXPERIMENTAL

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

Interventions

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.

Also known as: Mirror visual feedback exercise

Group A - Mirror Therapy; Group B - control period followed by Mirror Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- diagnosis of CRPS I based on the Budapest criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Motol: lead

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 25, 2023
• Study Start: September 9, 2013
• Primary Completion: September 30, 2015
• Study Completion: January 15, 2016
• Last Updated: October 25, 2023

Record last verified: 2023-10