Clinical Evaluation of the Effects of Mirror Therapy in Patients With Complex Regional Pain Syndrome (CRPS) Type 1

Complex Regional Pain Syndrome Type I Clinical Trial

Official title: Clinical Evaluation of the Effects of Mirror Therapy in Patients With Complex Regional Pain Syndrome (CRPS) Type 1:Prospective Randomized Single Blind Controlled Study

Status Completed

Clinical Trial Summary

CRPS Type 1 can occur after traumas, surgical applications or central nervous system disorders. The triggering factor in CRPS type 1 is fracture in about half of the cases. Mirror therapy is an innovative treatment approach that is cheap, easy to administer and non-invasive. It is thought that this treatment may be complementary to other rehabilitation methods.Neurophysiologic effects of mirror therapy are noted in the brain, especially in the parietal region, cerebellum, basal ganglia and premotor cortex. Mirror therapy is also effective through the mirror neuron system. Mirror therapy triggers neuroplasticity by increasing the connection between neurons in the brain and thereby enhances communication between the motor and the sensory cortex. Recent studies have shown the positive effects of mirror therapy in patients with CRPS Type 1 disease. There are two randomized controlled trials showing the efficacy of mirror therapy in patients with CRPS Type 1 after stroke. Only one pilot study was performed in patients with CRPS Type 1 who were traumatic origin. There are no randomized controlled trials investigating the efficacy of mirror therapy in CRPS Type 1 patients who developed secondary to trauma in the literature. The purpose of this study is to investigate the clinical effects of mirror therapy applied in addition to routine rehabilitation program in patients with traumatic CRPS Type 1. The investigators hypothesized that adjunctive mirror therapy to classical rehabilitation program would result in better outcomes compared with the classical program only.

Clinical Trial Description

This study is planned as a prospective randomized single blind controlled study. It was approved by the Ankara University Faculty of Medicine Ethics Committee and was conducted in accordance with the Declaration of Helsinki. This study will include 36 patients with CRPS type 1 who are referred to the Depart-ment of Physical Medicine and Rehabilitation, Hand Rehabilitation Unit at the Medical Faculty of Ankara University. Patients included in the scope of the study will randomly be divided into 2 groups as mirror group and control group. Random allocation software (RAS) program will be used to assign the patients to the treatment groups with "block randomization" method and to create the randomization scheme. In this single blinded study, all patients will be evaluated by the same physician (Dr. Elif Can Ozdemir). The physician will be blind to patient's assignment. Routine physical therapy and exercise program including contrast baths, hot pack, transcutaneous electrical nerve stimulation (TENS), desensitization, exercises and occupational therapy will be applied to all patients for a total of 4 weeks, 5 days a week, 1 hour/day. Mirror therapy will be applied to the mirror group for 30 minutes per day in addition to this routine treatment. Mirror therapy will include wrist flexion/extension, ulnar/radial deviation, hand finger flexion/extension and ab-duction/adduction, thumb abduction/adduction/opposition, and forearm supina-tion/pronation movements as well as various object grasping activities according to the status of the patient's hand functions. A total of 20 sessions of treatment will be given to each patient. The therapy will be given by the physiotherapists in the Hand Rehabilitation Unit. All individuals participating in the study will be assessed before and immediately after the treatment and also 1 month at follow-up. Each assessment will include pain severity, grip strength, lateral pinch strength, hand circumference measurements, hand dexterity, hand function in daily living activities, and health-related quality of life.As the primary outcome variable, the difference in pain measured by the Numerical Rating Scale between baseline and post-treatment is based. In the mirror group, at least 1 point difference in pain according to the control group is evaluated by Mann Whitney U test and it is necessary to take a total of 36 patients with 81% power and 5% error in each group, assuming 1 as the group standard deviation. Mann Whitney U and Wilcoxon test are planned for paired samples. P value of less than .05 is considered as statistically significant. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03377504
• Study type: Interventional
• Source: Ankara University
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Completion date: January 31, 2020