Scleroderma, SystemicPAIN SScNCT05622578
Phenotyping of Chronic Pain in Diffused Systemic Scleroderma
A study testing QST, CPM and Paisudoscan in people with Scleroderma, Systemic and Scleroderma, Diffuse, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective of the study is to describe the different phenotyping of pain in systemic scleroderma patients and perturbations of mechanisms of the pain. As secondary objectives, the study aims to describe the importances of overall symptoms in alteration of quality of life and conserve the questions which… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic, Scleroderma, Diffuse
- What is being tested?
- QST, CPM and Paisudoscan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2022to 4 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years;
- Patients with diffused SSc according to ACR / EULAR Classification 2013 since at least 3 months;
- For group pain: pain intensity ≥4 of 11 points of scale (NRS);
- For group painless: pain intensity on the month before inclusion.
Who cannot join
- Patients unable to understand french language;
- Patients no-affiliated to the french social security scheme;
- Patients under the french AME scheme;
- Patients under guardianship;
- Pregnant and breastfeeding patients;
- Patients with thermoalgesic neuropathy;
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- Articular pain from degenerative diseases (known osteoarthritis);
- Patients under antidepressant;
- Temporary discontinuation of analgesics which are not well tolerated.
Trial locations and contacts
1 site in 1 country.
France1 site
Center of evaluation and treatment of pain - Cochin hospital - APHP
Paris, 75014
About this study
Official title: Phenotyping of Chronic Pain in Diffused Systemic Scleroderma: Characteristics and Perturbations of Mechanisms of Pain, Impact on the Quality of Life and Correlations of Fatigue, Sleeping Disorders and Mood or Anxiety Disorders
The primary objective of the study is to describe the different phenotyping of pain in systemic scleroderma patients and perturbations of mechanisms of the pain.
As secondary objectives, the study aims to describe the importances of overall symptoms in alteration of quality of life and conserve the questions which will be associated in a unique questionnaire in order to evaluate the pain, the fatigue and the sleeping disorders in diffused systemic scleroderma patients.
Read the detailed description
This is a prospective, non-randomized, controlled study.
Beside the routine care, the patients will have only one visit in the study during which the informed consent will be signed, also the following will be performed: pain evaluation, blood sampling, questionnaires and Sudoscan, test QST.
100 patients will be enrolled in total with 50 in each group (scleroderma with pain vs. scleroderma without pain, 1:1 ratio), the duration of inclusion is estimated for 23 months.
2 centers will be involved in the enrollment of patients: rheumatology department and interne medicine department of Cochin hospital-APHP. One center will perform the evaluations of pain for all patients: center of pain of Cochin hospital - APHP.
- Conditions
- Scleroderma, Systemic, Scleroderma, Diffuse
- Being tested
- QST, CPM and Paisudoscan
- Keywords
- scleroderma, phenotyping
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QST, CPM and PaisudoscanOther
Quantified pain tests
| Study group | Role | What they receive |
|---|---|---|
| scleroderma with pain | Other | systemic sclerosis (SSc) with chronic pain Receives: Other: QST, CPM and Paisudoscan |
| scleroderma without pain | Other | systemic sclerosis patients without chronic pain Receives: Other: QST, CPM and Paisudoscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain
McGill Pain Questionnaire (MPQ) will be used.
McGill Pain Questionnaire is a self-report questionnaire for multidimensional pain assessment in chronic pain.
Measured: at baseline
Assessment of pain by NRS
Pain will be evaluated by the numerical pain rating scale (NRS).
Measured: at baseline
Assessment of pain by BPI
Pain will be evaluated by the Brief Pain Inventory (BPI)
Measured: at baseline
Assessment of pain by DN4
Pain will be evaluated by the Douleur Neuropathique (DN4) questionnaire as tool.
Measured: at baseline
Assessment of pain by Pain Detect Questionnaires
Pain will be evaluated by the painDETECT questionnaire.
Measured: at baseline
Assessment of pain by FiRST
Pain will be evaluated by the Fibromyalgia Rapid Screening Tool (FiRST).
Measured: at baseline
Secondary outcomes (3)
Assessment of quality of life by questionnaire EQ5D
By questionnaire EQ5D.
Measured: at baseline
Assessment of quality of life by questionnaire HAQ.
By questionnaire HAQ.
Measured: at baseline
SSc-SAQ questionnaire development
Questionnaire of symptoms associated with SSc.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start19 Oct 2022
- Primary completion19 Dec 2023
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Association de patients : association sclérodermies de France
- Responsible party
- Sponsor
- Investigators
- Serge PERROT, MD, PhD, Principal investigator, Center of evaluation and treatment of pain - Cochin hospital - APHPAnne Priscille TROUVIN, MD, Study director, Center of evaluation and treatment of pain - Cochin hospital - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622578
- Sponsor's protocol ID
- APHP220664
- Other IDs
- 2022-A01357-36
- Acronym
- PAIN SSc
- Status last verified
- Nov 2024
- First submitted
- 26 Sep 2022
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping of Chronic Pain in Diffused Systemic Scleroderma: Characteristics and Perturbations of Mechanisms of Pain, Impact on the Quality of Life and Correlations of Fatigue, Sleeping Disorders and Mood or Anxiety Disorders
- ClinicalTrials.gov ID
- NCT05622578
- Acronym / sponsor ID
- PAIN SSc / APHP220664
- Conditions
- Scleroderma, Systemic, Scleroderma, Diffuse
- Keywords
- scleroderma, phenotyping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Association de patients : association sclérodermies de France
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 18 Nov 2022 (actual)
- 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 primary objective of the study is to describe the different phenotyping of pain in systemic scleroderma patients and perturbations of mechanisms of the pain.
As secondary objectives, the study aims to describe the importances of overall symptoms in alteration of quality of life and conserve the questions which will be associated in a unique questionnaire in order to evaluate the pain, the fatigue and the sleeping disorders in diffused systemic scleroderma patients.
Detailed description
This is a prospective, non-randomized, controlled study.
Beside the routine care, the patients will have only one visit in the study during which the informed consent will be signed, also the following will be performed: pain evaluation, blood sampling, questionnaires and Sudoscan, test QST.
100 patients will be enrolled in total with 50 in each group (scleroderma with pain vs. scleroderma without pain, 1:1 ratio), the duration of inclusion is estimated for 23 months.
2 centers will be involved in the enrollment of patients: rheumatology department and interne medicine department of Cochin hospital-APHP. One center will perform the evaluations of pain for all patients: center of pain of Cochin hospital - APHP.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scleroderma with pain | Other | Other: QST, CPM and Paisudoscansystemic sclerosis (SSc) with chronic pain |
| scleroderma without pain | Other | Other: QST, CPM and Paisudoscansystemic sclerosis patients without chronic pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥ 18 years;
- Patients with diffused SSc according to ACR / EULAR Classification 2013 since at least 3 months;
- For group pain: pain intensity ≥4 of 11 points of scale (NRS);
- For group painless: pain intensity on the month before inclusion.
Key exclusion criteria (9 listed)
- Patients unable to understand french language;
- Patients no-affiliated to the french social security scheme;
- Patients under the french AME scheme;
- Patients under guardianship;
- Pregnant and breastfeeding patients;
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 |
|---|---|---|
| QST, CPM and PaisudoscanQuantified pain tests | Other | scleroderma with pain, scleroderma without pain |
Primary outcome
Assessment of pain
Time frame: at baseline
McGill Pain Questionnaire (MPQ) will be used. McGill Pain Questionnaire is a self-report questionnaire for multidimensional pain assessment in chronic pain.
Assessment of pain by NRS
Time frame: at baseline
Pain will be evaluated by the numerical pain rating scale (NRS).
Assessment of pain by BPI
Time frame: at baseline
Pain will be evaluated by the Brief Pain Inventory (BPI)
Assessment of pain by DN4
Time frame: at baseline
Pain will be evaluated by the Douleur Neuropathique (DN4) questionnaire as tool.
Assessment of pain by Pain Detect Questionnaires
Time frame: at baseline
Pain will be evaluated by the painDETECT questionnaire.
Assessment of pain by FiRST
Time frame: at baseline
Pain will be evaluated by the Fibromyalgia Rapid Screening Tool (FiRST).
3 secondary outcomes
Assessment of quality of life by questionnaire EQ5D
Time frame: at baseline
Assessment of quality of life by questionnaire HAQ.
Time frame: at baseline
SSc-SAQ questionnaire development
Time frame: through study completion, an average of 2 years
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 4 Dec 2024.
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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.
Serge PERROT, MD, PhD principal investigator
Center of evaluation and treatment of pain - Cochin hospital - APHP
Anne Priscille TROUVIN, MD study director
Center of evaluation and treatment of pain - Cochin hospital - APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QST, CPM and Paisudoscan in people with Scleroderma, Systemic and Scleroderma, Diffuse, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 9 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 4 Dec 2024. 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?
Assessment of pain (time frame: at baseline). The study lists 6 primary outcomes in all. 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 4 Dec 2024.