Complex Regional Pain Syndromes
Conditions
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.
Interventions
BEHAVIORALUsual 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
DEVICEGloreha device
Proprioceptive stimulation under visual feedback are provided by the Gloreha device. The intervention will last 30 minute a day x 4 weeks
Sponsors
University Hospital of Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale | Change measures (weeks: 0,4,16, 28) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
Countries
Italy
Contacts
Primary ContactSofia Straudi, MD
Backup ContactMarco Da Roit, PT
Outcome results
None listed