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Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS

Primary Purpose

Complex Regional Pain Syndromes

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Usual Physiotherapy
Gloreha device
Sponsored by
University Hospital of Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndromes

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ferrara University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Physiotherapy

Gloreha device

Arm Description

Outcomes

Primary Outcome Measures

Visual Analogue Scale

Secondary Outcome Measures

Neuropathic Pain Symptom Inventory
McGill Pain Questionnaire
The MPQ is a self-report measure of pain studied with a number of diagnoses. The MPQ assesses both the quality and intensity of subjective pain. The MPQ is composed of 78 words, of which respondents choose those that best describe their experience of pain.
Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version
Fugl-Meyer Upper Extremity
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66
Pressure Pain Threshold

Full Information

First Posted
March 16, 2015
Last Updated
February 2, 2017
Sponsor
University Hospital of Ferrara
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1. Study Identification

Unique Protocol Identification Number
NCT02395211
Brief Title
Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS
Official Title
Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS: An Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of Ferrara

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Physiotherapy
Arm Type
Active Comparator
Arm Title
Gloreha device
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Usual Physiotherapy
Intervention Description
Usual physiotherapy consist of active or passive mobilization, extensor digiti and carpi functional electric stimulation, occupational therapy and taping. The intervention will last 30 minute a day x 4 weeks
Intervention Type
Device
Intervention Name(s)
Gloreha device
Intervention Description
Proprioceptive stimulation under visual feedback are provided by the Gloreha device. The intervention will last 30 minute a day x 4 weeks
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Time Frame
Change measures (weeks: 0,4,16, 28)
Secondary Outcome Measure Information:
Title
Neuropathic Pain Symptom Inventory
Time Frame
Change measures (weeks: 0,4,16, 28)
Title
McGill Pain Questionnaire
Description
The MPQ is a self-report measure of pain studied with a number of diagnoses. The MPQ assesses both the quality and intensity of subjective pain. The MPQ is composed of 78 words, of which respondents choose those that best describe their experience of pain.
Time Frame
Change measures (weeks: 0,4,16, 28)
Title
Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version
Time Frame
Change measures (weeks: 0,4,16, 28)
Title
Fugl-Meyer Upper Extremity
Description
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66
Time Frame
Change measures (weeks: 0,4,16, 28)
Title
Pressure Pain Threshold
Time Frame
Change measures (weeks: 0,4,16, 28)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Straudi, MD
Phone
+ 390532238830
Email
sofia.straudi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Da Roit, PT
Phone
+39 0532238720
Email
m.daroit@ospfe.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD
Organizational Affiliation
Ferrara Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ferrara University Hospital
City
Ferrara
ZIP/Postal Code
44121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD
Phone
0532238720
Email
s.straudi@ospfe.it
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD
First Name & Middle Initial & Last Name & Degree
Marco Da Roit, PT
First Name & Middle Initial & Last Name & Degree
Claudia Pavarelli, PT
First Name & Middle Initial & Last Name & Degree
Fabio Manfredini, MD
First Name & Middle Initial & Last Name & Degree
Nicola Lamberti

12. IPD Sharing Statement

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Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS

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