Sensory Reeducation in Peripheral Nerve Injuries of Hand

Median Nerve Disease Clinical Trial

— HandtherRCT  

Official title:

Proposal of Sensory Reeducation in Peripheral Nerve Injuries of Median and Ulnar Nerves of the Hand: RANDOMIZED CONTROLLED CLINICAL STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215760
• Other study ID #: MFonseca
• Status: Completed
• Phase: N/A
• First received: July 1, 2010
• Last updated: May 26, 2015
• Start date: March 2009
• Est. completion date: December 2011

Study information

• Verified date: May 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Objectives: To develop a protocol for early treatment using sensory reeducation through the mirror after surgical reconstruction of the median nerve and / or ulnar hand, and its comparison with the evolution of the return of skin sensitivity after a not early rehabilitation which will be conducted by physiotherapists, with blinding of the evaluators.

Description:

Changes in the cerebral cortex begins soon after peripheral nerve injury resulting in overlapping cortical areas on adjacent as a result of the absence of stimuli in the area of cortical representation of the injured nerve. Sensibility reeducation is a process of reprogramming the brain through a progressive learning proposing feed the somatosensory cortex with alternative stimulus to preserve the cortical map of the hand and facilitate the sensory recovery. This study is based on the hypothesis that sensory reeducation starting in the first days after surgery by training with the mirror promotes greater preservation of the cortical map of the original hand, with better functional results. We also believe that sensory reeducation performed early with the mirror will enhance the return of sensibility, emphasizing functional reorganization with less alteration of the cortical map of the hand. Metodology: Will be included patients over 18 with injury of the median and/or ulnar nerve at the first week after surgery. Patients will be randomized into an early group with the use of mirror and a classic group of sensory reeducation. In evaluating the Rosen score will be used with motor, sensory and pain/discomfort components. The assessment instruments used were: Semmes Weinstein monofilaments, Jamar® and Pinch Gauge® dynamometer, goniometry, shape and texture identification (STI), Sollerman test, Disabilities of the arm, shoulder and hand questionnaire (DASH), two points discriminator and numeric pain scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients over 18 years

• male or female

• reconstruction of peripheral nerve or ulnar median

• primary or secondary graft through the Hospital of the Medical School of Ribeirão Preto, University São Paulo

• possible associated tendon and skin lesions

• flexor zones I, II, III, IV or V.

Exclusion Criteria:

• nerve damage that may associated with multiple complex lesions, bone or joint injuries

• presence of central nervous system injury

• chronic diseases metabolic and degenerative rheumatic diseases, leprosy and diseases affecting the peripheral nervous system.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Median Nerve Disease
• Median Neuropathy
• Nervous System Diseases
• Peripheral Nerve Disease
• Peripheral Nerve Injuries
• Peripheral Nervous System Diseases
• Ulnar Nerve Disease
• Ulnar Neuropathies

Intervention

Other:
• Training with a mirror
Early sensory reeducation group, started at the first week postoperatively, using specific guidelines using the mirror training and stimulation of the contralateral side. Initially, the stimulation will be unilateral and later bilateral, after the removal of the splint in 4 weeks.
• No mirror therapy
The classical group iniciates after 16 weeks postoperatively and follow a standard home protocol for sensory reeducation without the mirror. It begins with recognition of textures and objects, and specific rehabilitation, if any associated injuries.

Locations

Country	Name	City	State
Brazil	Lucy Montoro Institute of Rehabilitation	Ribeirão Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (33)

9. HANSSON, T.; NYMAN, T.; NYLANDER, L.; ROSÉN, B.; BJÖRKMAN, A.; LUNDBORG, G. Visuell observation av taktil stimulering mot handen aktiverar sensomotoriska omraden I hjärnan. Svenska Läkaresällskapets Riksstämma. 2004. Abstract.

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Dagum AB. Peripheral nerve regeneration, repair, and grafting. J Hand Ther. 1998 Apr-Jun;11(2):111-7. Review. — View Citation

Dellon AL, Jabaley ME. Reeducation of sensation in the hand following nerve suture. Clin Orthop Relat Res. 1982 Mar;(163):75-9. — View Citation

DELLON, A.L. Evaluation of sensibility and re-education of sensation in the hand. Williams & Wilkins, 1981.

DELLON, A.L.; Somatosensory testing and rehabilitation. The American Occupational Ther Ass, Inc. chapter:11, 246-293, 1997.

di Pellegrino G, Fadiga L, Fogassi L, Gallese V, Rizzolatti G. Understanding motor events: a neurophysiological study. Exp Brain Res. 1992;91(1):176-80. — View Citation

di Pellegrino G, Làdavas E, Farné A. Seeing where your hands are. Nature. 1997 Aug 21;388(6644):730. — View Citation

di Pellegrino G, Wise SP. Visuospatial versus visuomotor activity in the premotor and prefrontal cortex of a primate. J Neurosci. 1993 Mar;13(3):1227-43. — View Citation

Jerosch-Herold C. Assessment of sensibility after nerve injury and repair: a systematic review of evidence for validity, reliability and responsiveness of tests. J Hand Surg Br. 2005 Jun;30(3):252-64. Review. — View Citation

Johansson BB. Brain plasticity in health and disease. Keio J Med. 2004 Dec;53(4):231-46. Review. — View Citation

Lundborg G, Rosén B, Lindberg S. Hearing as substitution for sensation: a new principle for artificial sensibility. J Hand Surg Am. 1999 Mar;24(2):219-24. — View Citation

Lundborg G. Brain plasticity and hand surgery: an overview. J Hand Surg Br. 2000 Jun;25(3):242-52. Review. — View Citation

Lundborg G. Nerve injury and repair - regeneration, reconstruction and cortical remodeling. Elsevier, Churchill Livingstone, 2a . ed. Cap.8, 9, 10 e 11, 198-244.

Lundborg G. Richard P. Bunge memorial lecture. Nerve injury and repair--a challenge to the plastic brain. J Peripher Nerv Syst. 2003 Dec;8(4):209-26. — View Citation

LUNDBORG, G. Nerve injury and repair. Edinburgh, Churchill Livingstone, 1988.

McAllister RM, Gilbert SE, Calder JS, Smith PJ. The epidemiology and management of upper limb peripheral nerve injuries in modern practice. J Hand Surg Br. 1996 Feb;21(1):4-13. — View Citation

Merzenich MM, Jenkins WM. Reorganization of cortical representations of the hand following alterations of skin inputs induced by nerve injury, skin island transfers, and experience. J Hand Ther. 1993 Apr-Jun;6(2):89-104. Review. — View Citation

Noble J, Munro CA, Prasad VS, Midha R. Analysis of upper and lower extremity peripheral nerve injuries in a population of patients with multiple injuries. J Trauma. 1998 Jul;45(1):116-22. — View Citation

Novak CB. Evaluation of hand sensibility: a review. J Hand Ther. 2001 Oct-Dec;14(4):266-72. Review. — View Citation

Orfale AG, Araújo PM, Ferraz MB, Natour J. Translation into Brazilian Portuguese, cultural adaptation and evaluation of the reliability of the Disabilities of the Arm, Shoulder and Hand Questionnaire. Braz J Med Biol Res. 2005 Feb;38(2):293-302. Epub 2005 — View Citation

Pons TP, Garraghty PE, Ommaya AK, Kaas JH, Taub E, Mishkin M. Massive cortical reorganization after sensory deafferentation in adult macaques. Science. 1991 Jun 28;252(5014):1857-60. — View Citation

Rizzolatti G, Craighero L. The mirror-neuron system. Annu Rev Neurosci. 2004;27:169-92. Review. — View Citation

Rizzolatti G, Fogassi L, Gallese V. Neurophysiological mechanisms underlying the understanding and imitation of action. Nat Rev Neurosci. 2001 Sep;2(9):661-70. Review. — View Citation

Rizzolatti G, Luppino G. The cortical motor system. Neuron. 2001 Sep 27;31(6):889-901. Review. — View Citation

Rosén B, Balkenius C, Lundborg G. Sensory re-education today and tomorrow: a review of evolving concepts. British Journal of Hand Therapy. v. 8, p. 48-56, 2003.

Rosén B, Lundborg G. A model instrument for the documentation of outcome after nerve repair. J Hand Surg Am. 2000 May;25(3):535-43. — View Citation

Rosén B, Lundborg G. A new tactile gnosis instrument in sensibility testing. J Hand Ther. 1998 Oct-Dec;11(4):251-7. — View Citation

Rosén B, Lundborg G. Early use of artificial sensibility to improve sensory recovery after repair of the median and ulnar nerve. Scand J Plast Reconstr Surg Hand Surg. 2003;37(1):54-7. — View Citation

Rosén B, Lundborg G. The long term recovery curve in adults after median or ulnar nerve repair: a reference interval. J Hand Surg Br. 2001 Jun;26(3):196-200. — View Citation

Rosén B, Lundborg G. Training with a mirror in rehabilitation of the hand. Scand J Plast Reconstr Surg Hand Surg. 2005;39(2):104-8. — View Citation

Rosén B. Recovery of sensory and motor function after nerve repair. A rationale for evaluation. J Hand Ther. 1996 Oct-Dec;9(4):315-27. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensory threshold	Semmes Weinstein monofilaments	1 month	Yes
Secondary	sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength	Semmes Weinstein monofilaments, Jamar® and Pinch Gauge® dynamometer, goniometry, shape and texture identification (STI), Sollerman test, Disabilities of the arm, shoulder and hand questionnaire (DASH), two points discriminator and numeric pain scale	3 months	Yes
Secondary	sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength	Semmes Weinstein monofilaments, Jamar® and Pinch Gauge® dynamometer, goniometry, shape and texture identification (STI), Sollerman test, Disabilities of the arm, shoulder and hand questionnaire (DASH), two points discriminator and numeric pain scale	6 months	Yes
Secondary	sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength	Semmes Weinstein monofilaments, Jamar® and Pinch Gauge® dynamometer, goniometry, shape and texture identification (STI), Sollerman test, Disabilities of the arm, shoulder and hand questionnaire (DASH), two points discriminator and numeric pain scale	12 months	Yes

External Links

•   School of Medicine - University of são Paulo