Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS

Complex Regional Pain Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02395211
• Other study ID #: Studio_CRPS_gloreha
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2015
• Last updated: February 2, 2017
• Start date: January 2015
• Est. completion date: June 2018

Study information

• Verified date: February 2017
• Source: University Hospital of Ferrara
• Contact: Sofia Straudi, MD
• Phone: + 390532238830
• Email: sofia.straudi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy

Intervention

Behavioral:
• Usual Physiotherapy
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

Device:
• Gloreha device
Proprioceptive stimulation under visual feedback are provided by the Gloreha device. The intervention will last 30 minute a day x 4 weeks

Locations

Country	Name	City	State
Italy	Ferrara University Hospital	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale		Change measures (weeks: 0,4,16, 28)
Secondary	Neuropathic Pain Symptom Inventory		Change measures (weeks: 0,4,16, 28)
Secondary	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.	Change measures (weeks: 0,4,16, 28)
Secondary	Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version		Change measures (weeks: 0,4,16, 28)
Secondary	Fugl-Meyer Upper Extremity	Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66	Change measures (weeks: 0,4,16, 28)
Secondary	Pressure Pain Threshold		Change measures (weeks: 0,4,16, 28)