Complex Regional Pain SyndromesSDRCNCT02901002
Body Perception and Complex Regional Pain Syndrome
An observational study of Complex Regional Pain Syndromes, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
In CRPS, perturbation of body image and pseudo-neglect syndrome of the body part affected are frequently found. Pain and sensory perturbation seems to modify the way patients perceived their body part affected. Does a local body image perturbation can affect the balanced of the global self-awareness? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- Sensory testing in the two hand and Neuropsychological evaluation
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2017to 27 Oct 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients suffering from CRPS of the lower limb and Healthy controls
Who may be able to join
- For patients:
- a diagnosis of CRPS of the lower limb according to the Budapest Criteria (men or women) For patients and control group
- Age ≥ 18 years
Who cannot join
- For patients and control group
- neurological disease with cerebral repercussion or not stabilized serious physical illness;
- psychotropic medication
- disorders related to the use of a psychoactive substance (abuse, dependence or withdrawal);
- For patients:
- Presence of an other pain disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Perception and Complex Regional Pain Syndrome : a Case-control Study
In CRPS, perturbation of body image and pseudo-neglect syndrome of the body part affected are frequently found. Pain and sensory perturbation seems to modify the way patients perceived their body part affected.
Does a local body image perturbation can affect the balanced of the global self-awareness?
Read the detailed description
With the investigation of spontaneous sensations (SPS) according to the protocol of Michael and al (2011) the investigators study how patients can listen to their internal sensations located in other body part than the painful member in order to construct a representation of the body and maintain it in active consciousness. A group of controls will be included to understand if there is a global modification in the perception of SPS witch may be linked to the pathology.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- Sensory testing in the two hand, Neuropsychological evaluation
- Keywords
- Complex Regional Pain Syndromes, Pain, Spontaneous sensations, interoception
- Medical subject headings
- Complex Regional Pain Syndromes, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory testing in the two handOther
spontaneous sensations while watching a hand
Neuropsychological evaluationOther
Score to anxiety-depression scale
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients suffering from CRPS of the lower limb Patients with sensory testing in the two hand and neuropsychological evaluation Receives: Other: Sensory testing in the two hand; Other: Neuropsychological evaluation | |
| Control | Healthy controls match by age, gender, Body Mass Index Healthy volunteers with sensory testing in the two hand and neuropsychological evaluation Receives: Other: Sensory testing in the two hand; Other: Neuropsychological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory testing
areas of the hand where spontaneous sensations were felt
Measured: day 1
Secondary outcomes (1)
Neurological evaluation by questionary
Score to HAD (anxiety-depression) scale
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start6 Jan 2017
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christelle CREAC'H, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901002
- Sponsor's protocol ID
- 1608097
- Other IDs
- 2016-A01248-43
- Acronym
- SDRC
- Status last verified
- Nov 2017
- First submitted
- 5 Sep 2016
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Perception and Complex Regional Pain Syndrome : a Case-control Study
- ClinicalTrials.gov ID
- NCT02901002
- Acronym / sponsor ID
- SDRC / 1608097
- Conditions
- Complex Regional Pain Syndromes
- Keywords
- Complex Regional Pain Syndromes, Pain, Spontaneous sensations, interoception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 15 Sep 2016 (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.
In CRPS, perturbation of body image and pseudo-neglect syndrome of the body part affected are frequently found. Pain and sensory perturbation seems to modify the way patients perceived their body part affected.
Does a local body image perturbation can affect the balanced of the global self-awareness?
Detailed description
With the investigation of spontaneous sensations (SPS) according to the protocol of Michael and al (2011) the investigators study how patients can listen to their internal sensations located in other body part than the painful member in order to construct a representation of the body and maintain it in active consciousness. A group of controls will be included to understand if there is a global modification in the perception of SPS witch may be linked to the pathology.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Sensory testing in the two hand, Other: Neuropsychological evaluationPatients suffering from CRPS of the lower limb Patients with sensory testing in the two hand and neuropsychological evaluation |
| Control | – | Other: Sensory testing in the two hand, Other: Neuropsychological evaluationHealthy controls match by age, gender, Body Mass Index Healthy volunteers with sensory testing in the two hand and neuropsychological evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from CRPS of the lower limb and Healthy controls
Key inclusion criteria (3 listed)
- For patients:
- Age ≥ 18 years
Key exclusion criteria (6 listed)
- For patients and control group
- neurological disease with cerebral repercussion or not stabilized serious physical illness;
- psychotropic medication
- disorders related to the use of a psychoactive substance (abuse, dependence or withdrawal);
- Presence of an other pain disorder
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 |
|---|---|---|
| Sensory testing in the two handspontaneous sensations while watching a hand | Other | Control, Patient |
| Neuropsychological evaluationScore to anxiety-depression scale | Other | Control, Patient |
Primary outcome
Sensory testing
Time frame: day 1
areas of the hand where spontaneous sensations were felt
1 secondary outcome
Neurological evaluation by questionary
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Christelle CREAC'H, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Regional Pain Syndromes, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 6 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: finished, as of the sponsor's last update on 17 Jan 2018. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory testing (time frame: day 1). 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 17 Jan 2018.