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

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ClinicalTrials.gov Identifier: NCT03377504
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Ayşe A Küçükdeveci, MD, Ankara University

Tracking Information
First Submitted Date  ICMJE December 14, 2017
First Posted Date  ICMJE December 19, 2017
Last Update Posted Date July 3, 2019
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
Pain severity [ Time Frame: change from baseline at 4 weeks and 8 weeks ]
"0-10 Numeric Rating Scale (NRS)" will be used to assess current pain severity. 0 points minimum 10 points indicates the maximum value. Low scores are associated with better clinical outcomes.
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
Pain severity [ Time Frame: change from baseline at 4 weeks and 8 weeks ]
"0-10 Numeric Rating Scale (NRS)" will be used to assess current pain severity.
Change History Complete list of historical versions of study NCT03377504 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
  • Grip strength [ Time Frame: change from baseline at 4 weeks and 8 weeks ]
    The Jamar dynamometer will be used to measure the grip strength. The best result of the 3 sequential measurements will be taken into account
  • Lateral pinch strength [ Time Frame: change from baseline at 4 weeks and 8 weeks ]
    A pinchmeter will be used to measure the lateral pinch strength. The best result of the 3 sequential measurements will be taken into account.
  • Hand circumference measurements [ Time Frame: change from baseline at 4 weeks and 8 weeks ]
    Two measurements will be made: one at the level of ulnar styloid process, second at the level of the third distal metacarpal tip
  • Hand dexterity [ Time Frame: change from baseline at 4 weeks and 8 weeks ]
    Moberg pick up test will be used.
  • Hand function in daily living activities [ Time Frame: change from baseline at 4 weeks and 8 weeks ]
    Cochin Hand Function Scale (CHFS) will be used.0 points minimum 90 points shows the maximum value. Low scores are associated with better clinical outcomes.
  • Health-related quality of life [ Time Frame: change from baseline at 4 weeks and 8 weeks ]
    The Nottingham Health Profile (NHP) will be used
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
  • Grip strength [ Time Frame: change from baseline at 4 weeks and 8 weeks ]
    The Jamar dynamometer will be used to measure the grip strength. The best result of the 3 sequential measurements will be taken into account
  • Lateral pinch strength [ Time Frame: change from baseline at 4 weeks and 8 weeks ]
    A pinchmeter will be used to measure the lateral pinch strenth. The best result of the 3 sequential measurements will be taken into account.
  • Hand circumference measurements [ Time Frame: change from baseline at 4 weeks and 8 weeks ]
    Two measurements will be made: one at the level of ulnar styloid process, second at the level of the third distal metacarpal tip
  • Hand dexterity [ Time Frame: change from baseline at 4 weeks and 8 weeks ]
    Moberg pick up test will be used.
  • Hand function in daily living activities [ Time Frame: change from baseline at 4 weeks and 8 weeks ]
    Cochin Hand Function Scale (CHFS) will be used.
  • Health-related quality of life [ Time Frame: change from baseline at 4 weeks and 8 weeks ]
    The Nottingham Health Profile (NHP) will be used
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of the Effects of Mirror Therapy in Patients With Complex Regional Pain Syndrome (CRPS) Type 1
Official Title  ICMJE Clinical Evaluation of the Effects of Mirror Therapy in Patients With Complex Regional Pain Syndrome (CRPS) Type 1:Prospective Randomized Single Blind Controlled Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective randomized single blind controlled study
Masking: Single (Outcomes Assessor)
Masking Description:
single blind (outcomes assessor)
Primary Purpose: Treatment
Condition  ICMJE Complex Regional Pain Syndrome Type I
Intervention  ICMJE
  • Behavioral: mirror therapy
    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.
  • Behavioral: Routine physical therapy and exercise program
    Routine physical therapy and exercise program including contrast baths, hot pack, TENS, desensitization, exercises and occupational therapy will be applied to all patients
Study Arms  ICMJE
  • Experimental: mirror group
    Routine physical therapy and exercise program 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.
    Intervention: Behavioral: mirror therapy
  • Active Comparator: control group
    Routine physical therapy and exercise program will be applied to all patients for a total of 4 weeks, 5 days a week, 1 hour/day. A total of 20 sessions of treatment will be given to each patient.
    Intervention: Behavioral: Routine physical therapy and exercise program
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 14, 2017)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ayşe Adile Küçükdeveci 0312 508 28 50 ayse.kucukdeveci@gmail.com
Contact: Elif Can Özdemir 0312 508 22 03 elif.can.90@hotmail.com
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03377504
Other Study ID Numbers  ICMJE 03-109-17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ayşe A Küçükdeveci, MD, Ankara University
Study Sponsor  ICMJE Ankara University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ayşe Adile Küçükdeveci Ankara University
PRS Account Ankara University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP