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Clinical Trials/NCT01215760
NCT01215760
Completed
Not Applicable

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

University of Sao Paulo1 site in 1 country30 target enrollmentMarch 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Median Nerve Disease
Sponsor
University of Sao Paulo
Enrollment
30
Locations
1
Primary Endpoint
sensory threshold
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
December 2011
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marisa de Cassia Registro Fonseca

Professor

University of Sao Paulo

Eligibility Criteria

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.

Outcomes

Primary Outcomes

sensory threshold

Time Frame: 1 month

Semmes Weinstein monofilaments

Secondary Outcomes

  • sensory threshold, range of motion, pain, function, tactile gnosia, pinch and grip strength(12 months)

Study Sites (1)

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