Clinical trial NCT06100107: Mirror Therapy in Complex Regional Pain Syndrome Type I
Official title: Mirror Visual Feedback as Therapeutic Modality in Unilateral Upper Extremity Complex Regional Pain Syndrome Type I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Regional Pain Syndrome Type I
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain perception
timeFrame: 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).
measure: Active Range of Motion
timeFrame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
measure: Strength
timeFrame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
measure: Dexterity
timeFrame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
measure: Volume of hand and forearm
timeFrame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
measure: Temperature
timeFrame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
measure: Health-related Quality of Life
timeFrame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Secondary outcomes:
Other outcomes:
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