Clinical Evaluation of the Effects of Mirror Therapy in Patients With Complex Regional Pain Syndrome (CRPS) Type 1
Condition: Complex Regional Pain Syndrome Type I
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Somatoform Disorders
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): mirror therapy; Routine physical therapy and exercise program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mirror therapy will include wrist flexion/extension, ulnar/radial deviation, hand finger flexion/extension and abduction/adduction, thumb abduction/adduction/opposition, and forearm supination/pronation movements as well as various object grasping activities according to the status of the patient's hand functions.; Routine physical therapy and exercise program including contrast baths, hot pack, TENS, desensitization, exercises and occupational therapy will be applied to all patients
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized single blind controlled study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: complex regional pain syndrome; mirror therapy; rehabilitation