Complex Regional Pain SyndromesNCT02395211
Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS
A study testing Usual Physiotherapy and Gloreha device in people with Complex Regional Pain Syndromes, run by University Hospital of Ferrara at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- Usual Physiotherapy and Gloreha device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- neurological or psychiatric pathology
- severe cardio-pulmonary, renal, hepatic diseases
- pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ferrara University Hospital
Ferrara, Ferrara, 44121
Sofia Straudi, MD, 0532238720, s.straudi@ospfe.it
Sofia Straudi, MD
About this study
Official title: Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS: An Exploratory Study
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.
Read the 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.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- Usual Physiotherapy, Gloreha device
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual PhysiotherapyBehavioural
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
Gloreha deviceDevice
Proprioceptive stimulation under visual feedback are provided by the Gloreha device. The intervention will last 30 minute a day x 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Usual Physiotherapy | Active comparator | Not described Receives: Behavioral: Usual Physiotherapy |
| Gloreha device | Experimental | Not described Receives: Device: Gloreha device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Measured: Change measures (weeks: 0,4,16, 28)
Secondary outcomes (5)
Neuropathic Pain Symptom Inventory
Measured: Change measures (weeks: 0,4,16, 28)
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.
Measured: Change measures (weeks: 0,4,16, 28)
Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version
Measured: Change measures (weeks: 0,4,16, 28)
Fugl-Meyer Upper Extremity
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66
Measured: Change measures (weeks: 0,4,16, 28)
Pressure Pain Threshold
Measured: Change measures (weeks: 0,4,16, 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofia Straudi, MD, Principal investigator, Ferrara Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395211
- Sponsor's protocol ID
- Studio_CRPS_gloreha
- Status last verified
- Feb 2017
- First submitted
- 16 Mar 2015
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS: An Exploratory Study
- ClinicalTrials.gov ID
- NCT02395211
- Acronym / sponsor ID
- Studio_CRPS_gloreha
- Conditions
- Complex Regional Pain Syndromes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 23 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Physiotherapy | Active comparator | Behavioral: Usual Physiotherapy |
| Gloreha device | Experimental | Device: Gloreha device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- neurological or psychiatric pathology
- severe cardio-pulmonary, renal, hepatic diseases
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual PhysiotherapyUsual 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 | Behavioural | Usual Physiotherapy |
| Gloreha deviceProprioceptive stimulation under visual feedback are provided by the Gloreha device. The intervention will last 30 minute a day x 4 weeks | Device | Gloreha device |
Primary outcome
Visual Analogue Scale
Time frame: Change measures (weeks: 0,4,16, 28)
5 secondary outcomes
Neuropathic Pain Symptom Inventory
Time frame: Change measures (weeks: 0,4,16, 28)
McGill Pain Questionnaire
Time frame: Change measures (weeks: 0,4,16, 28)
Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version
Time frame: Change measures (weeks: 0,4,16, 28)
Fugl-Meyer Upper Extremity
Time frame: Change measures (weeks: 0,4,16, 28)
Pressure Pain Threshold
Time frame: Change measures (weeks: 0,4,16, 28)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
Related trials for Complex Regional Pain Syndromes
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 3
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
Recruiting
The Effectiveness of Conservative Treatment in Patients With Complex Regional Pain Syndrome.
CRPS (Complex Regional Pain Syndromes)
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofia Straudi, MD principal investigator
Ferrara Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual Physiotherapy and Gloreha device in people with Complex Regional Pain Syndromes, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sofia Straudi, MD (+ 390532238830, sofia.straudi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Change measures (weeks: 0,4,16, 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.