An interventional study of mirror therapy and Routine physical therapy and exercise program in Complex Regional Pain Syndrome Type I, sponsored by Ankara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-25.
Sponsored by Ankara University · Not applicable, Interventional, and Treatment
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Among 14 studies in Complex Regional Pain Syndromes with a site in Turkey — 7 open to participants now, 7 under way, none of them phase 3. Complex Regional Pain Syndromes · Turkey.
Among the 14 studies in Complex Regional Pain Syndromes with a site in Turkey, this one is the 9th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2017, is one of 10 with no phase, and was the 1st registered.
206 studies on the registry are indexed under Complex Regional Pain Syndromes; 54 are open to participants now.
Browse Complex Regional Pain Syndromes studies →7 of the 14 studies in Complex Regional Pain Syndromes with a site in Turkey are open now. Recruiting first, the newest first:
Dilek ün oguzhanasilturk · Sites in Turkey
Ages 18–75
Ankara Etlik City Hospital · Sites in Turkey
Ages 18–80
Afyonkarahisar Health Sciences University · Sites in Turkey
Ages 18–70
Ankara City Hospital Bilkent · Sites in Turkey
Ages 18–75
Ankara City Hospital Bilkent · Sites in Turkey
Ages 18–80
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 39 Complex Regional Pain Syndromes studies recruiting now, 17 (44%) set no upper age limit and 16 (41%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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14 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 1 started in 2017.
This study's enrollment of 36 is close to the median of 40 across 152 interventional studies indexed under Complex Regional Pain Syndromes.
Median enrollment 48 across the 10 interventional studies, 80 across the 4 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 14 has an industry lead sponsor. The 10 most frequent:
Ankara University is the lead sponsor of 320 studies on the registry; 64 are open to participants now.
Ankara University has 1 study filed under Complex Regional Pain Syndromes — fewer than ten, so there is no comparison to draw.
3 of the studies in Complex Regional Pain Syndromes with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07744269Ankara Etlik City HospitalCRPS-Hand: Contrast + Compression vs Whirlpool | 2027-04-30 |
| NCT07807852Dilek ün oguzhanasilturkESWT for CRPS-I After Distal Radius Fracture | 2027-06-26 |
| NCT07858812Izmir Democracy UniversityValidity and Reliability of the Turkish Version of the Revised Bath CRPS Body Perception Disturbance Scale | 2027-10-15 |
Add all 3 to your calendar (.ics) → With an account.
Among the 14 studies in Complex Regional Pain Syndromes with a site in Turkey, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: mirror therapy
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.
Behavioral: Routine physical therapy and exercise program
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
Pain severity
"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.
Time frame: change from baseline at 4 weeks and 8 weeks
Grip strength
The Jamar dynamometer will be used to measure the grip strength. The best result of the 3 sequential measurements will be taken into account
Time frame: change from baseline at 4 weeks and 8 weeks
Lateral pinch strength
A pinchmeter will be used to measure the lateral pinch strength. The best result of the 3 sequential measurements will be taken into account.
Time frame: change from baseline at 4 weeks and 8 weeks
Hand circumference measurements
Two measurements will be made: one at the level of ulnar styloid process, second at the level of the third distal metacarpal tip
Time frame: change from baseline at 4 weeks and 8 weeks
Hand dexterity
Moberg pick up test will be used.
Time frame: change from baseline at 4 weeks and 8 weeks
Hand function in daily living activities
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.
Time frame: change from baseline at 4 weeks and 8 weeks
Health-related quality of life
The Nottingham Health Profile (NHP) will be used
Time frame: change from baseline at 4 weeks and 8 weeks
Plan to share: No
Ran from Mar 2017 to primary completion in Dec 2019, 33 months.
Of 64 non-industry interventional studies with no phase under Complex Regional Pain Syndromes, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's 33 months is above that.
Counting every sponsor, half of 65 studies reached it within 24 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Complex Regional Pain Syndromes →