Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS

Not Applicable

• Conditions: Complex Regional Pain Syndromes
• Interventions: Behavioral: Usual Physiotherapy; Device: Gloreha device

• Registration Number: NCT02395211
• Lead Sponsor: University Hospital of Ferrara

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-23
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Physiotherapy	Usual Physiotherapy	-
Gloreha device	Gloreha device	-

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	Change measures (weeks: 0,4,16, 28)

Secondary Outcome Measures

Name	Time	Method
Neuropathic Pain Symptom Inventory	Change measures (weeks: 0,4,16, 28)
McGill Pain Questionnaire	Change measures (weeks: 0,4,16, 28)	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	Change measures (weeks: 0,4,16, 28)
Fugl-Meyer Upper Extremity	Change measures (weeks: 0,4,16, 28)	Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66
Pressure Pain Threshold	Change measures (weeks: 0,4,16, 28)

Trial Locations

Locations (1)

Ferrara University Hospital; 🇮🇹 Ferrara, Italy