Clinical trial NCT03377504: Clinical Evaluation of the Effects of Mirror Therapy in Patients With Complex Regional Pain Syndrome (CRPS) Type 1
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Regional Pain Syndrome Type I
Keywords: complex regional pain syndrome
mirror therapy
rehabilitation
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized single blind controlled study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adult individuals over 18 years of age
* CRPS type 1 diagnosis according to 2003 Budapest diagnostic criteria
* Patients who developed CRPS Type 1 due to traumatic causes (surgical procedures, fractures, immobilization)
* Patients who agree to participate in the study and sign the informed consent form

Exclusion Criteria:

* Patients with peripheral nerve injuries (those with a diagnosis of CRPS type 2 according to Budapest criteria)
* Patients with CRPS Type 1 after central nervous system injury (stroke)
* Patients in the acute and post-acute rehabilitation who have had primary or secondary tendon repair of the hand
* The presence of comorbid conditions (e.g. decompensated heart failure, chronic renal insufficiency, malignancy) that would impair the functioning of the person and the health-related quality of life
* The presence of comorbid disease affecting hand function (e.g. rheumatoid arthritis, psoriatic arthritis or other inflammatory diseases that cause hand involvement)
* Patients with acute deep venous thrombosis and arterial thrombosis of the upper extremity
* Patients with arterial / venous injury and / or undergoing arterial revascularization
* Patients with excessive alcohol and inappropriate opioid use
* Patients with untreated psychiatric problems (major depression, anxiety, schizophrenia, etc.)
* Patients with recurrent CRPS Type 1

Primary outcomes:
measure: Pain severity
timeFrame: change from baseline at 4 weeks and 8 weeks
Secondary outcomes:
measure: Grip strength
timeFrame: change from baseline at 4 weeks and 8 weeks
measure: Lateral pinch strength
timeFrame: change from baseline at 4 weeks and 8 weeks
measure: Hand circumference measurements
timeFrame: change from baseline at 4 weeks and 8 weeks
measure: Hand dexterity
timeFrame: change from baseline at 4 weeks and 8 weeks
measure: Hand function in daily living activities
timeFrame: change from baseline at 4 weeks and 8 weeks
measure: Health-related quality of life
timeFrame: change from baseline at 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine, İbn-i Sina Research and Application Hospital
Study officials:
affiliation: Ankara University
name: Ayşe Adile Küçükdeveci
role: PRINCIPAL_INVESTIGATOR
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