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

NCT03377504 | Completed

• 1 other identifier: 03-109-17
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndrome Type I

Keywords

complex regional pain syndrome; mirror therapy; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  change from baseline at 4 weeks and 8 weeks

Secondary Outcomes (6)

• Grip strength

  change from baseline at 4 weeks and 8 weeks

• Lateral pinch strength

  change from baseline at 4 weeks and 8 weeks

• Hand circumference measurements

  change from baseline at 4 weeks and 8 weeks

• Hand dexterity

  change from baseline at 4 weeks and 8 weeks

• Hand function in daily living activities

  change from baseline at 4 weeks and 8 weeks

Study Arms (2)

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.

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.

Behavioral: Routine physical therapy and exercise program

Interventions

mirror therapy BEHAVIORAL

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.

mirror group

Routine physical therapy and exercise program BEHAVIORAL

Routine physical therapy and exercise program including contrast baths, hot pack, TENS, desensitization, exercises and occupational therapy will be applied to all patients

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine, İbn-i Sina Research and Application Hospital

Ankara, 06030, Turkey (Türkiye)

Location

Related Publications (18)

• 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.

  PMID: 19386737 BACKGROUND

• Maihofner 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.

  PMID: 20180838 BACKGROUND

• Swart 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.

  PMID: 19101181 BACKGROUND

• Ramachandran 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.

  PMID: 8637922 BACKGROUND

• Sutbeyaz 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.

  PMID: 17466722 BACKGROUND

• Stevens 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.

  PMID: 12881842 BACKGROUND

• Samuelkamaleshkumar 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.

  PMID: 25064777 BACKGROUND

• Dohle 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.

  PMID: 19074686 BACKGROUND

• Cacchio 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.

  PMID: 19465507 BACKGROUND

• Moseley 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.

  PMID: 17082465 BACKGROUND

• Giraux 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.

  PMID: 14597303 BACKGROUND

• Moseley 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.

  PMID: 18621484 BACKGROUND

• Rizzolatti G, Craighero L. The mirror-neuron system. Annu Rev Neurosci. 2004;27:169-92. doi: 10.1146/annurev.neuro.27.070203.144230.

  PMID: 15217330 BACKGROUND

• McCabe 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.

  PMID: 12509620 BACKGROUND

• Pervane 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.

  PMID: 26723854 BACKGROUND

• Garry MI, Loftus A, Summers JJ. Mirror, mirror on the wall: viewing a mirror reflection of unilateral hand movements facilitates ipsilateral M1 excitability. Exp Brain Res. 2005 May;163(1):118-22. doi: 10.1007/s00221-005-2226-9. Epub 2005 Mar 8.

  PMID: 15754176 BACKGROUND

• Yavuzer G, Selles R, Sezer N, Sutbeyaz S, Bussmann JB, Koseoglu F, Atay MB, Stam HJ. Mirror therapy improves hand function in subacute stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2008 Mar;89(3):393-8. doi: 10.1016/j.apmr.2007.08.162.

  PMID: 18295613 BACKGROUND

• Wasner G, Schattschneider J, Binder A, Baron R. Complex regional pain syndrome--diagnostic, mechanisms, CNS involvement and therapy. Spinal Cord. 2003 Feb;41(2):61-75. doi: 10.1038/sj.sc.3101404.

  PMID: 12595868 BACKGROUND

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Ayşe Adile Küçükdeveci

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single blind (outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Medicine and Rehabilitation

Model Details: Prospective randomized single blind controlled study

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 19, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: January 31, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)