Complex Regional Pain Syndrome Type INCT03377504
Clinical Evaluation of the Effects of Mirror Therapy in Patients With Complex Regional Pain Syndrome (CRPS) Type 1
A study testing mirror therapy and Routine physical therapy and exercise program in people with Complex Regional Pain Syndrome Type I, run by Ankara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complex Regional Pain Syndrome Type I
- What is being tested?
- mirror therapy and Routine physical therapy and exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine, İbn-i Sina Research and Application Hospital
Ankara, 06030
About this study
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
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.
Read the 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.
- Conditions
- Complex Regional Pain Syndrome Type I
- Being tested
- mirror therapy, Routine physical therapy and exercise program
- Keywords
- complex regional pain syndrome, mirror therapy, rehabilitation
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirror therapyBehavioural
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 programBehavioural
Routine physical therapy and exercise program including contrast baths, hot pack, TENS, desensitization, exercises and occupational therapy will be applied to all patients
| Study group | Role | What they receive |
|---|---|---|
| mirror group | Experimental | 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. Receives: Behavioral: mirror therapy |
| control group | Active comparator | 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. Receives: Behavioral: Routine physical therapy and exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline at 4 weeks and 8 weeks
Secondary outcomes (6)
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
Measured: 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.
Measured: 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
Measured: change from baseline at 4 weeks and 8 weeks
Hand dexterity
Moberg pick up test will be used.
Measured: 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.
Measured: change from baseline at 4 weeks and 8 weeks
Health-related quality of life
The Nottingham Health Profile (NHP) will be used
Measured: change from baseline at 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Mar 2017
- Primary completion1 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain Syndrome Type IStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized single blind controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe A Küçükdeveci, MD, Ankara University
- Investigators
- Ayşe Adile Küçükdeveci, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377504
- Sponsor's protocol ID
- 03-109-17
- Status last verified
- Feb 2020
- First submitted
- 14 Dec 2017
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwenkreis P, Maier C, Tegenthoff M. Functional imaging of central nervous system involvement in complex regional pain syndrome. AJNR Am J Neuroradiol. 2009 Aug;30(7):1279-84. doi: 10.3174/ajnr.A1630. Epub 2009 Apr 22.
PubMed 19386737Maihofner C, Seifert F, Markovic K. Complex regional pain syndromes: new pathophysiological concepts and therapies. Eur J Neurol. 2010 May;17(5):649-60. doi: 10.1111/j.1468-1331.2010.02947.x. Epub 2010 Feb 18.
PubMed 20180838Swart CM, Stins JF, Beek PJ. Cortical changes in complex regional pain syndrome (CRPS). Eur J Pain. 2009 Oct;13(9):902-7. doi: 10.1016/j.ejpain.2008.11.010. Epub 2008 Dec 19.
PubMed 19101181Ramachandran VS, Rogers-Ramachandran D. Synaesthesia in phantom limbs induced with mirrors. Proc Biol Sci. 1996 Apr 22;263(1369):377-86. doi: 10.1098/rspb.1996.0058.
PubMed 8637922Sutbeyaz S, Yavuzer G, Sezer N, Koseoglu BF. Mirror therapy enhances lower-extremity motor recovery and motor functioning after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2007 May;88(5):555-9. doi: 10.1016/j.apmr.2007.02.034.
PubMed 17466722Stevens JA, Stoykov ME. Using motor imagery in the rehabilitation of hemiparesis. Arch Phys Med Rehabil. 2003 Jul;84(7):1090-2. doi: 10.1016/s0003-9993(03)00042-x.
PubMed 12881842Samuelkamaleshkumar S, Reethajanetsureka S, Pauljebaraj P, Benshamir B, Padankatti SM, David JA. Mirror therapy enhances motor performance in the paretic upper limb after stroke: a pilot randomized controlled trial. Arch Phys Med Rehabil. 2014 Nov;95(11):2000-5. doi: 10.1016/j.apmr.2014.06.020. Epub 2014 Jul 23.
PubMed 25064777Dohle C, Pullen J, Nakaten A, Kust J, Rietz C, Karbe H. Mirror therapy promotes recovery from severe hemiparesis: a randomized controlled trial. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):209-17. doi: 10.1177/1545968308324786. Epub 2008 Dec 12.
PubMed 19074686Cacchio A, De Blasis E, De Blasis V, Santilli V, Spacca G. Mirror therapy in complex regional pain syndrome type 1 of the upper limb in stroke patients. Neurorehabil Neural Repair. 2009 Oct;23(8):792-9. doi: 10.1177/1545968309335977. Epub 2009 May 22.
PubMed 19465507Moseley GL. Graded motor imagery for pathologic pain: a randomized controlled trial. Neurology. 2006 Dec 26;67(12):2129-34. doi: 10.1212/01.wnl.0000249112.56935.32. Epub 2006 Nov 2.
PubMed 17082465Giraux P, Sirigu A. Illusory movements of the paralyzed limb restore motor cortex activity. Neuroimage. 2003 Nov;20 Suppl 1:S107-11. doi: 10.1016/j.neuroimage.2003.09.024.
PubMed 14597303Moseley LG, Gallace A, Spence C. Is mirror therapy all it is cracked up to be? Current evidence and future directions. Pain. 2008 Aug 15;138(1):7-10. doi: 10.1016/j.pain.2008.06.026. Epub 2008 Jul 14. No abstract available.
PubMed 18621484Rizzolatti G, Craighero L. The mirror-neuron system. Annu Rev Neurosci. 2004;27:169-92. doi: 10.1146/annurev.neuro.27.070203.144230.
PubMed 15217330McCabe CS, Haigh RC, Ring EF, Halligan PW, Wall PD, Blake DR. A controlled pilot study of the utility of mirror visual feedback in the treatment of complex regional pain syndrome (type 1). Rheumatology (Oxford). 2003 Jan;42(1):97-101. doi: 10.1093/rheumatology/keg041.
PubMed 12509620Pervane Vural S, Nakipoglu Yuzer GF, Sezgin Ozcan D, Demir Ozbudak S, Ozgirgin N. Effects of Mirror Therapy in Stroke Patients With Complex Regional Pain Syndrome Type 1: A Randomized Controlled Study. Arch Phys Med Rehabil. 2016 Apr;97(4):575-581. doi: 10.1016/j.apmr.2015.12.008. Epub 2015 Dec 23.
PubMed 26723854
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03377504
- Acronym / sponsor ID
- 03-109-17
- Conditions
- Complex Regional Pain Syndrome Type I
- Keywords
- complex regional pain syndrome, mirror therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized single blind controlled study
| Arm | Type | Receives |
|---|---|---|
| mirror group | Experimental | Behavioral: mirror therapyRoutine 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. |
| control group | Active comparator | Behavioral: Routine physical therapy and exercise programRoutine 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirror therapyMirror 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. | Behavioural | mirror group |
| Routine physical therapy and exercise programRoutine physical therapy and exercise program including contrast baths, hot pack, TENS, desensitization, exercises and occupational therapy will be applied to all patients | Behavioural | control group |
Primary outcome
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.
6 secondary outcomes
Grip strength
Time frame: change from baseline at 4 weeks and 8 weeks
Lateral pinch strength
Time frame: change from baseline at 4 weeks and 8 weeks
Hand circumference measurements
Time frame: change from baseline at 4 weeks and 8 weeks
Hand dexterity
Time frame: change from baseline at 4 weeks and 8 weeks
Hand function in daily living activities
Time frame: change from baseline at 4 weeks and 8 weeks
Health-related quality of life
Time frame: change from baseline at 4 weeks and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 19386737Schwenkreis P, Maier C, Tegenthoff M. Functional imaging of central nervous system involvement in complex regional pain syndrome. AJNR Am J Neuroradiol. 2009 Aug;30(7):1279-84. doi: 10.3174/ajnr.A1630. Epub 2009 Apr 22.
- Background: PubMed 20180838Maihofner C, Seifert F, Markovic K. Complex regional pain syndromes: new pathophysiological concepts and therapies. Eur J Neurol. 2010 May;17(5):649-60. doi: 10.1111/j.1468-1331.2010.02947.x. Epub 2010 Feb 18.
- Background: PubMed 19101181Swart CM, Stins JF, Beek PJ. Cortical changes in complex regional pain syndrome (CRPS). Eur J Pain. 2009 Oct;13(9):902-7. doi: 10.1016/j.ejpain.2008.11.010. Epub 2008 Dec 19.
- Background: PubMed 8637922Ramachandran VS, Rogers-Ramachandran D. Synaesthesia in phantom limbs induced with mirrors. Proc Biol Sci. 1996 Apr 22;263(1369):377-86. doi: 10.1098/rspb.1996.0058.
- Background: PubMed 17466722Sutbeyaz S, Yavuzer G, Sezer N, Koseoglu BF. Mirror therapy enhances lower-extremity motor recovery and motor functioning after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2007 May;88(5):555-9. doi: 10.1016/j.apmr.2007.02.034.
- Background: PubMed 12881842Stevens JA, Stoykov ME. Using motor imagery in the rehabilitation of hemiparesis. Arch Phys Med Rehabil. 2003 Jul;84(7):1090-2. doi: 10.1016/s0003-9993(03)00042-x.
- Background: PubMed 25064777Samuelkamaleshkumar S, Reethajanetsureka S, Pauljebaraj P, Benshamir B, Padankatti SM, David JA. Mirror therapy enhances motor performance in the paretic upper limb after stroke: a pilot randomized controlled trial. Arch Phys Med Rehabil. 2014 Nov;95(11):2000-5. doi: 10.1016/j.apmr.2014.06.020. Epub 2014 Jul 23.
- Background: PubMed 19074686Dohle C, Pullen J, Nakaten A, Kust J, Rietz C, Karbe H. Mirror therapy promotes recovery from severe hemiparesis: a randomized controlled trial. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):209-17. doi: 10.1177/1545968308324786. Epub 2008 Dec 12.
- Background: PubMed 19465507Cacchio A, De Blasis E, De Blasis V, Santilli V, Spacca G. Mirror therapy in complex regional pain syndrome type 1 of the upper limb in stroke patients. Neurorehabil Neural Repair. 2009 Oct;23(8):792-9. doi: 10.1177/1545968309335977. Epub 2009 May 22.
- Background: PubMed 17082465Moseley GL. Graded motor imagery for pathologic pain: a randomized controlled trial. Neurology. 2006 Dec 26;67(12):2129-34. doi: 10.1212/01.wnl.0000249112.56935.32. Epub 2006 Nov 2.
- Background: PubMed 14597303Giraux P, Sirigu A. Illusory movements of the paralyzed limb restore motor cortex activity. Neuroimage. 2003 Nov;20 Suppl 1:S107-11. doi: 10.1016/j.neuroimage.2003.09.024.
- Background: PubMed 18621484Moseley LG, Gallace A, Spence C. Is mirror therapy all it is cracked up to be? Current evidence and future directions. Pain. 2008 Aug 15;138(1):7-10. doi: 10.1016/j.pain.2008.06.026. Epub 2008 Jul 14. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe Adile Küçükdeveci principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mirror therapy and Routine physical therapy and exercise program in people with Complex Regional Pain Syndrome Type I, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity (time frame: change from baseline at 4 weeks and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377504, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.