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Clinical Trials/NCT02395211
NCT02395211
Unknown
Not Applicable

Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS: An Exploratory Study

University Hospital of Ferrara1 site in 1 country20 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complex Regional Pain Syndromes
Sponsor
University Hospital of Ferrara
Enrollment
20
Locations
1
Primary Endpoint
Visual Analogue Scale
Last Updated
9 years ago

Overview

Brief Summary

The aim of this study is to evaluate feasibility of a proprioceptive stimulation under visual feedback treatment protocol (using Gloreha® device) compared to usual physiotherapy treatment in sub-acute stroke patient with Complex regional pain syndrome.

Detailed Description

The aim of this study is to evaluate feasibility of a a proprioceptive stimulation under visual feedback treatment protocol (using Gloreha® device) compared to usual physiotherapy treatment in sub-acute stroke patient with Complex regional pain syndrome. Treatments effect will be evaluated on pain perception, upper extremity functionality and change in pain pressure treshold. Usual physiotherapy consist of active or passive mobilization, extensor digiti and carpi functional electric stimulation, occupational therapy and taping.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
June 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital of Ferrara
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age \> 18 years and \< 85 years
  • diagnosis of stroke \< 6 months prior to study enrollment
  • diagnosis of Complex regional pain syndrome according to Budapest Criteria

Exclusion Criteria

  • neurological or psychiatric pathology
  • severe cardio-pulmonary, renal, hepatic diseases
  • pregnancy

Outcomes

Primary Outcomes

Visual Analogue Scale

Time Frame: Change measures (weeks: 0,4,16, 28)

Secondary Outcomes

  • Neuropathic Pain Symptom Inventory(Change measures (weeks: 0,4,16, 28))
  • McGill Pain Questionnaire(Change measures (weeks: 0,4,16, 28))
  • Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version(Change measures (weeks: 0,4,16, 28))
  • Fugl-Meyer Upper Extremity(Change measures (weeks: 0,4,16, 28))
  • Pressure Pain Threshold(Change measures (weeks: 0,4,16, 28))

Study Sites (1)

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