Complex Regional Pain Syndrome Type INCT04703647
Longitudinal Follow-up Study About Complex Regional Pain Syndrome (CRPS) Patients
An observational study of Complex Regional Pain Syndrome Type I, run by Clinique Romande de Readaptation at 1 site in Switzerland.
Trial summary
Complex regional pain syndrome (CRPS) is a post-traumatic chronic pain condition characterized by pain and other symptoms typically affecting a distal limb. Relatively little is known about the prognosis of the course of CRPS .Currently there is no specific test to diagnose CRPS. 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 Syndrome Type I
- What is being tested?
- Administration of questionnaires for prospective group and Blood samples for prospective group
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Mar 2019to 25 Sep 2026
- 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: Study participants will be recruited among the patients admitted for acute CRPS of the upper or lower limb in the CRR. It will be only ambulatory patients.The screening, recruitment and enrolment of the patients will be done by the referring physician in daily clinical practice, during the consultation. For control group (blood analysis) we will recruit 30 healthy controls who did not report any kind of pain. The healthy control will be adjusted for age, sex and BMI with the CRPS groups. They will be informed about the study and procedure. The procedure for the blood samples will be the same as for patients.
Who may be able to join
- CRPS Type I (fulfilling Budapest criteria for research)
- Suffering of CRPS in a distal limb (hand or foot)
- Age >18 years
- Pain lasting less than 6 months
- Good understanding of the French language
- Not suffering from chronic pain, including CRPS
- Age >18 years
Who cannot join
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, severe psychological disorders, dementia, etc
- For blood sample: diabetes and history of hepatitis B, C, D or HIV infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Follow-up Study About Complex Regional Pain Syndrome (CRPS). Which Are the Predictors for Return to Work and Recovery
Complex regional pain syndrome (CRPS) is a post-traumatic chronic pain condition characterized by pain and other symptoms typically affecting a distal limb. Relatively little is known about the prognosis of the course of CRPS .Currently there is no specific test to diagnose CRPS.
The primary objective of the study is to investigate prospectively the evolution of CRPS and the impact of the psychosocial factors on health status, recovery, quality of life, and working status of CRPS patients.
The secondary objective of the study is to measure blood parameters in CRPS patients to investigate their evolution during the course of CRPS, and maybe to identify distinctive biomarkers associate with CRPS and that could be potential candidate for diagnosis.
Read the detailed description
The first aim will be to monitor the evolution of the following parameters in CRPS patients:
- Quality of life
- Symptoms and signs of CRPS
- Severity of CRPS
- Working status
- Pain
- Disability
- Anxiety and depression
- Kinesiophobia
- Catastrophism
- Activity patterns with chronic pain during the two years follow-up. Every parameter will be evaluated with a questionnaire that allows assigning scores to each patient.
Additionally sociodemographic data will be collected to characterize the patients (age, gender, marital status, educational level). The health status, treatment and medication of the patients will also be recorded with a medical follow-up during the two years.
The aim is to know if the following parameters and their evolution:
- Sociodemographic factors,
- Pain,
- Disability,
- Anxiety and depression,
- Kinesiophobia,
- Catastrophism,
- Activity patterns with chronic pain are associated with the recovery, which is evaluated with
- Quality of life,
- Severity of CRPS,
- And working status.
Potential associations between the different parameters will be tested (Pearson's correlation coefficient).
The second aim will be to assess, in blood samples, the expression levels of specific molecules (miRNAs and a selection of cytokines) in patients diagnosed with acute CRPS. Comparison with healthy controls will be performed at the first measurement time (T0) . In a second time, miRNAs and cytokines profiles will be compared between acute and chronic (CRPS still diagnosed 6 months after the first diagnosis) CRPS patients. The measured proteins will include: C-reactive protein, tumor necrosis factor-alpha (TNF), interleukin-2 [IL-2], IL-6, IL-8, IL-10, CD40 ligand (pro- and anti-inflammatory proteins associated with pain), gene related peptide (CGRP), bradykinins and substance P.
The screening, recruitment and enrolment of the patients will be done by the referring physician in daily clinical practice, during the consultation.
The physician will explain to each participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail. Each participant will be informed that the participation in the study is voluntary and that he/she may withdraw from the study at any time and that withdrawal of consent will not affect his/her subsequent medical assistance and treatment.
All participants for the study will be provided with a participant information sheet,a consent form describing the study and providing sufficient information for participant to make an informed decision about their participation in the study and a prepaid envelope. Each patient may decide separately to participate in a) longitudinal follow-up questionnaires, b) blood tests or c) both parts of the study (questionnaire and blood samples). The delay for reflection will be 24 h. Once this period has expired, if the patient agrees to participate in the study, he or she is asked to return the consent form in the prepaid envelope. If he or she has not been send back after one week, the physician will call the patient by phone to make sure that it is not an omission.
The patient information sheet and the consent form are submitted to the Ethic comitee to be reviewed and approved. The formal consent of a participant, using the approved consent form, must be obtained before the participant is submitted to any study procedure.
The participant should read and consider the statement before signing and dating the informed consent form, and should be given a copy of the signed document. If the patient sent back the informed consent, a next appointment will be scheduled at the CRR where he or she will be asked to submit the signed consent form. The consent form must also be signed and dated by the investigator (or his designee) and it will be retained as part of the study records.
The total duration of the project is planned over a six years period (2019-2024). The study will be proposed to every CRPS ambulatory patient in the CRR (2019-2022), inclusion period). The study will also be proposed to the patients during the last two years (2023-2024) but only partially, since that last questionnaires will be sent in December 2024.
The CRPS patients are monitored on a regular and long-term basis at the CRR. The physician see them very regularly at the beginning (about once a month) and then the visits space a little out. Thus, our study fits into routine procedure and should not imply additional visits.
At the first visit at the clinic, the physician will proposed the study to the patient. Upon acceptance, the patient will be included into the study. It consists in five measurement times:
- T0: During the days following the first visit to the clinic
- T1: Follow up visit 3 months later
- T2: Follow up visit 6 months later
- T3: Follow up visit 12 months later
- T4: Follow up visit 24 months later
- Conditions
- Complex Regional Pain Syndrome Type I
- Being tested
- Administration of questionnaires for prospective group, Blood samples for prospective group, Blood samples for control group
- Keywords
- pain, biopsychosocial model, miRNAs, cytokines, upper limb, lower limb
- 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.
Administration of questionnaires for prospective groupOther
Questionnaires: administration at T0, T1,T2,T3 and T4 of Short Form Health Survey (SF-36),Brief Pain Inventory (BPI),Disabilities of the Arm, Shoulder and Hand (DASH) for upper limb,Foot and Ankle Ability Measure (FAAM) for lower limb,Hospital Anxiety And Depression Scale (HADS),Tampa Scale of Kinesiophobia (TSK),Pain Catastrophizing Scale (PCS),Pattern Of Activity Measure - Pain (POAM-P) .
Blood samples for prospective groupOther
Blood samples at T0,T1,T2 and T3.
Blood samples for control groupOther
Blood samples just one time
| Study group | Role | What they receive |
|---|---|---|
| Patients with CRPS type 1: prospective group | Ambulatory patients of the Clinique romande de réadaptation (CRR) which have a CRPS type 1 of a limb.
Five measurement times (first visit (T0) and then after 3 (T1), 6 (T2), 12 (T3) and 24 (T4) months). At every time point, following data will be collected: physical examination, monitoring of the health and professional status with the physician, and self-administrated questionnaires. Blood sampling will be performed at T0, T1,T2 and T3.
Eight different self-administrated questionnaires will be used, in their French or Portuguese version. Each participants will answer seven questionnaires each time, depending if he/she suffers of arm or leg injury.
We will assess, in blood samples, the expression levels of specific molecules (miRNAs and a selection of cytokines) in patients diagnosed with acute CRPS. In a second time, miRNAs and cytokines profiles will be compared between acute and chronic (CRPS still diagnosed 6 months after the first diagnosis) CRPS patients. Receives: Other: Administration of questionnaires for prospective group; Other: Blood samples for prospective group | |
| control group for blood analysis | For the blood analysis, we will recruit 30 healthy controls who did not report any kind of pain. They will be recruited via posters that will be posted on the billboards of the Hôpital de Sion (employees and visitors) and on the visitor's billboards of the CRR. If this is not enough, we will expand the recruitment perimeter with other locations. The healthy control will be adjusted for age, sex and BMI with the CRPS groups. They will be informed about the study and procedure. The procedure for the blood samples will be the same as for patients.The screening for miRNAs of interest will be performed using a decision tree-based ensemble method (Random Forest). For this step, miRNAs profile of 30 control patients will be compared to the same number of CRPS patients.
The control group will have just one blood analysis. Receives: Other: Blood samples for control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient return to work (RTW)
Percentage of patients return to work at T1
Measured: 3 months after inclusion
patient return to work (RTW)
Percentage of patients return to work at T2
Measured: 6 months after inclusion
patient return to work (RTW)
Percentage of patients return to work at T3
Measured: 1 year after inclusion
patient return to work (RTW)
Percentage of patients return to work at T4
Measured: 2 years after inclusion
Recovery of CRPS
Disability of the patients evaluated with DASH questionnaire for upper limb and FAMM questionnaire for lower limb at T1. For DASH the score range from 0 to 100, with 100 represent the worst disability. For FAMM the score range from 0 to 100, 100 represent the best functionality.
Measured: 3 months after inclusion
Recovery of CRPS
Disability of the patients evaluated with DASH questionnaire for upper limb and FAMM questionnaire for lower limb at T2. For DASH the score range from 0 to 100, with 100 represent the worst disability. For FAMM the score range from 0 to 100, 100 represent the best functionality.
Measured: 6 months after inclusion
Recovery of CRPS
Disability of the patients evaluated with DASH questionnaire for upper limb and FAMM questionnaire for lower limb at T3. For DASH the score range from 0 to 100, with 100 represent the worst disability. For FAMM the score range from 0 to 100, 100 represent the best functionality.
Measured: 1 year after inclusion
Recovery of CRPS
Disability of the patients evaluated with DASH questionnaire for upper limb and FAMM questionnaire for lower limb at T4. For DASH the score range from 0 to 100, with 100 represent the worst disability. For FAMM the score range from 0 to 100, 100 represent the best functionality.
Measured: 2 years after inclusion
Secondary outcomes (4)
miRNAs and cytokines profile of patients and control
Mesure in blood samples of miRNAs and cytokines in patients and 30 healthy control at T0
Measured: at T0 (after inclusion)
miRNAs and cytokines profile of patients
Mesure in blood samples of miRNAs and cytokines in patients at T1
Measured: 3 months after inclusion
miRNAs and cytokines profile of patients
Mesure in blood samples of miRNAs and cytokines in patients at T2
Measured: 6 months after inclusion
miRNAs and cytokines profile of patients
Mesure in blood samples of miRNAs and cytokines in patients at T3
Measured: 1 year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start14 Mar 2019
- Primary completion1 Dec 2024
- Study completion25 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain Syndrome Type IStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Romande de Readaptation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Bertrand Léger, PhD, Study director, institut de recherche en réadaptatation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703647
- Sponsor's protocol ID
- CliniqueRR-20
- Status last verified
- Aug 2023
- First submitted
- 9 Dec 2020
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Protocol of the study
Publications
Konig S, Schlereth T, Birklein F. Molecular signature of complex regional pain syndrome (CRPS) and its analysis. Expert Rev Proteomics. 2017 Oct;14(10):857-867. doi: 10.1080/14789450.2017.1366859. Epub 2017 Aug 17.
PubMed 28803495Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Chont M, Vatine JJ. Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome. Pain. 2010 Aug;150(2):268-274. doi: 10.1016/j.pain.2010.04.030. Epub 2010 May 20.
PubMed 20493633Orlova IA, Alexander GM, Qureshi RA, Sacan A, Graziano A, Barrett JE, Schwartzman RJ, Ajit SK. MicroRNA modulation in complex regional pain syndrome. J Transl Med. 2011 Nov 10;9:195. doi: 10.1186/1479-5876-9-195.
PubMed 22074333Galer BS, Henderson J, Perander J, Jensen MP. Course of symptoms and quality of life measurement in Complex Regional Pain Syndrome: a pilot survey. J Pain Symptom Manage. 2000 Oct;20(4):286-92. doi: 10.1016/s0885-3924(00)00183-4.
PubMed 11027911Bean DJ, Johnson MH, Heiss-Dunlop W, Kydd RR. Extent of recovery in the first 12 months of complex regional pain syndrome type-1: A prospective study. Eur J Pain. 2016 Jul;20(6):884-94. doi: 10.1002/ejp.813. Epub 2015 Nov 2.
PubMed 26524108Bean DJ, Johnson MH, Heiss-Dunlop W, Kydd RR. Factors Associated With Disability and Sick Leave in Early Complex Regional Pain Syndrome Type-1. Clin J Pain. 2016 Feb;32(2):130-8. doi: 10.1097/AJP.0000000000000234.
PubMed 25803756Bean DJ, Johnson MH, Heiss-Dunlop W, Lee AC, Kydd RR. Do psychological factors influence recovery from complex regional pain syndrome type 1? A prospective study. Pain. 2015 Nov;156(11):2310-2318. doi: 10.1097/j.pain.0000000000000282.
PubMed 26133727Birklein F, Ajit SK, Goebel A, Perez RSGM, Sommer C. Complex regional pain syndrome - phenotypic characteristics and potential biomarkers. Nat Rev Neurol. 2018 May;14(5):272-284. doi: 10.1038/nrneurol.2018.20. Epub 2018 Mar 16.
PubMed 29545626Le Carre J, Lamon S, Leger B. Validation of a multiplex reverse transcription and pre-amplification method using TaqMan((R)) MicroRNA assays. Front Genet. 2014 Nov 26;5:413. doi: 10.3389/fgene.2014.00413. eCollection 2014.
PubMed 25505484
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Follow-up Study About Complex Regional Pain Syndrome (CRPS). Which Are the Predictors for Return to Work and Recovery
- ClinicalTrials.gov ID
- NCT04703647
- Acronym / sponsor ID
- CliniqueRR-20
- Conditions
- Complex Regional Pain Syndrome Type I
- Keywords
- pain, biopsychosocial model, miRNAs, cytokines, upper limb, lower limb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Clinique Romande de ReadaptationResearch network
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 25 Sep 2026 (actual)
- First posted
- 11 Jan 2021 (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.
Complex regional pain syndrome (CRPS) is a post-traumatic chronic pain condition characterized by pain and other symptoms typically affecting a distal limb. Relatively little is known about the prognosis of the course of CRPS .Currently there is no specific test to diagnose CRPS.
The primary objective of the study is to investigate prospectively the evolution of CRPS and the impact of the psychosocial factors on health status, recovery, quality of life, and working status of CRPS patients.
The secondary objective of the study is to measure blood parameters in CRPS patients to investigate their evolution during the course of CRPS, and maybe to identify distinctive biomarkers associate with CRPS and that could be potential candidate for diagnosis.
Detailed description
The first aim will be to monitor the evolution of the following parameters in CRPS patients:
- Quality of life
- Symptoms and signs of CRPS
- Severity of CRPS
- Working status
- Pain
- Disability
- Anxiety and depression
- Kinesiophobia
- Catastrophism
- Activity patterns with chronic pain during the two years follow-up. Every parameter will be evaluated with a questionnaire that allows assigning scores to each patient.
Additionally sociodemographic data will be collected to characterize the patients (age, gender, marital status, educational level). The health status, treatment and medication of the patients will also be recorded with a medical follow-up during the two years.
The aim is to know if the following parameters and their evolution:
- Sociodemographic factors,
- Pain,
- Disability,
- Anxiety and depression,
- Kinesiophobia,
- Catastrophism,
- Activity patterns with chronic pain are associated with the recovery, which is evaluated with
- Quality of life,
- Severity of CRPS,
- And working status.
Potential associations between the different parameters will be tested (Pearson's correlation coefficient).
The second aim will be to assess, in blood samples, the expression levels of specific molecules (miRNAs and a selection of cytokines) in patients diagnosed with acute CRPS. Comparison with healthy controls will be performed at the first measurement time (T0) . In a second time, miRNAs and cytokines profiles will be compared between acute and chronic (CRPS still diagnosed 6 months after the first diagnosis) CRPS patients. The measured proteins will include: C-reactive protein, tumor necrosis factor-alpha (TNF), interleukin-2 [IL-2], IL-6, IL-8, IL-10, CD40 ligand (pro- and anti-inflammatory proteins associated with pain), gene related peptide (CGRP), bradykinins and substance P.
The screening, recruitment and enrolment of the patients will be done by the referring physician in daily clinical practice, during the consultation.
The physician will explain to each participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail. Each participant will be informed that the participation in the study is voluntary and that he/she may withdraw from the study at any time and that withdrawal of consent will not affect his/her subsequent medical assistance and treatment.
All participants for the study will be provided with a participant information sheet,a consent form describing the study and providing sufficient information for participant to make an informed decision about their participation in the study and a prepaid envelope. Each patient may decide separately to participate in a) longitudinal follow-up questionnaires, b) blood tests or c) both parts of the study (questionnaire and blood samples). The delay for reflection will be 24 h. Once this period has expired, if the patient agrees to participate in the study, he or she is asked to return the consent form in the prepaid envelope. If he or she has not been send back after one week, the physician will call the patient by phone to make sure that it is not an omission.
The patient information sheet and the consent form are submitted to the Ethic comitee to be reviewed and approved. The formal consent of a participant, using the approved consent form, must be obtained before the participant is submitted to any study procedure.
The participant should read and consider the statement before signing and dating the informed consent form, and should be given a copy of the signed document. If the patient sent back the informed consent, a next appointment will be scheduled at the CRR where he or she will be asked to submit the signed consent form. The consent form must also be signed and dated by the investigator (or his designee) and it will be retained as part of the study records.
The total duration of the project is planned over a six years period (2019-2024). The study will be proposed to every CRPS ambulatory patient in the CRR (2019-2022), inclusion period). The study will also be proposed to the patients during the last two years (2023-2024) but only partially, since that last questionnaires will be sent in December 2024.
The CRPS patients are monitored on a regular and long-term basis at the CRR. The physician see them very regularly at the beginning (about once a month) and then the visits space a little out. Thus, our study fits into routine procedure and should not imply additional visits.
At the first visit at the clinic, the physician will proposed the study to the patient. Upon acceptance, the patient will be included into the study. It consists in five measurement times:
- T0: During the days following the first visit to the clinic
- T1: Follow up visit 3 months later
- T2: Follow up visit 6 months later
- T3: Follow up visit 12 months later
- T4: Follow up visit 24 months later
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with CRPS type 1: prospective group | – | Other: Administration of questionnaires for prospective group, Other: Blood samples for prospective groupAmbulatory patients of the Clinique romande de réadaptation (CRR) which have a CRPS type 1 of a limb. Five measurement times (first visit (T0) and then after 3 (T1), 6 (T2), 12 (T3) and 24 (T4) months). At every time point, following data will be collected: physical examination, monitoring of the health and professional status with the physician, and self-administrated questionnaires. Blood sampling will be performed at T0, T1,T2 and T3. Eight different self-administrated questionnaires will be used, in their French or Portuguese version. Each participants will answer seven questionnaires each time, depending if he/she suffers of arm or leg injury. We will assess, in blood samples, the expression levels of specific molecules (miRNAs and a selection of cytokines) in patients diagnosed with acute CRPS. In a second time, miRNAs and cytokines profiles will be compared between acute and chronic (CRPS still diagnosed 6 months after the first diagnosis) CRPS patients. |
| control group for blood analysis | – | Other: Blood samples for control groupFor the blood analysis, we will recruit 30 healthy controls who did not report any kind of pain. They will be recruited via posters that will be posted on the billboards of the Hôpital de Sion (employees and visitors) and on the visitor's billboards of the CRR. If this is not enough, we will expand the recruitment perimeter with other locations. The healthy control will be adjusted for age, sex and BMI with the CRPS groups. They will be informed about the study and procedure. The procedure for the blood samples will be the same as for patients.The screening for miRNAs of interest will be performed using a decision tree-based ensemble method (Random Forest). For this step, miRNAs profile of 30 control patients will be compared to the same number of CRPS patients. The control group will have just one blood analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited among the patients admitted for acute CRPS of the upper or lower limb in the CRR. It will be only ambulatory patients.The screening, recruitment and enrolment of the patients will be done by the referring physician in daily clinical practice, during the consultation. For control group (blood analysis) we will recruit 30 healthy controls who did not report any kind of pain. The healthy control will be adjusted for age, sex and BMI with the CRPS groups. They will be informed about the study and procedure. The procedure for the blood samples will be the same as for patients.
Key inclusion criteria (7 listed)
- CRPS Type I (fulfilling Budapest criteria for research)
- Suffering of CRPS in a distal limb (hand or foot)
- Age >18 years
- Pain lasting less than 6 months
- Good understanding of the French language
Key exclusion criteria (3 listed)
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, severe psychological disorders, dementia, etc
- For blood sample: diabetes and history of hepatitis B, C, D or HIV infection
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 |
|---|---|---|
| Administration of questionnaires for prospective groupQuestionnaires: administration at T0, T1,T2,T3 and T4 of Short Form Health Survey (SF-36),Brief Pain Inventory (BPI),Disabilities of the Arm, Shoulder and Hand (DASH) for upper limb,Foot and Ankle Ability Measure (FAAM) for lower limb,Hospital Anxiety And Depression Scale (HADS),Tampa Scale of Kinesiophobia (TSK),Pain Catastrophizing Scale (PCS),Pattern Of Activity Measure - Pain (POAM-P) . | Other | Patients with CRPS type 1: prospective group |
| Blood samples for prospective groupBlood samples at T0,T1,T2 and T3. | Other | Patients with CRPS type 1: prospective group |
| Blood samples for control groupBlood samples just one time | Other | control group for blood analysis |
Primary outcome
patient return to work (RTW)
Time frame: 3 months after inclusion
Percentage of patients return to work at T1
patient return to work (RTW)
Time frame: 6 months after inclusion
Percentage of patients return to work at T2
patient return to work (RTW)
Time frame: 1 year after inclusion
Percentage of patients return to work at T3
patient return to work (RTW)
Time frame: 2 years after inclusion
Percentage of patients return to work at T4
Recovery of CRPS
Time frame: 3 months after inclusion
Disability of the patients evaluated with DASH questionnaire for upper limb and FAMM questionnaire for lower limb at T1. For DASH the score range from 0 to 100, with 100 represent the worst disability. For FAMM the score range from 0 to 100, 100 represent the best functionality.
Recovery of CRPS
Time frame: 6 months after inclusion
Disability of the patients evaluated with DASH questionnaire for upper limb and FAMM questionnaire for lower limb at T2. For DASH the score range from 0 to 100, with 100 represent the worst disability. For FAMM the score range from 0 to 100, 100 represent the best functionality.
Recovery of CRPS
Time frame: 1 year after inclusion
Disability of the patients evaluated with DASH questionnaire for upper limb and FAMM questionnaire for lower limb at T3. For DASH the score range from 0 to 100, with 100 represent the worst disability. For FAMM the score range from 0 to 100, 100 represent the best functionality.
Recovery of CRPS
Time frame: 2 years after inclusion
Disability of the patients evaluated with DASH questionnaire for upper limb and FAMM questionnaire for lower limb at T4. For DASH the score range from 0 to 100, with 100 represent the worst disability. For FAMM the score range from 0 to 100, 100 represent the best functionality.
4 secondary outcomes
miRNAs and cytokines profile of patients and control
Time frame: at T0 (after inclusion)
miRNAs and cytokines profile of patients
Time frame: 3 months after inclusion
miRNAs and cytokines profile of patients
Time frame: 6 months after inclusion
miRNAs and cytokines profile of patients
Time frame: 1 year after inclusion
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 30 Sep 2026.
- Background: PubMed 28803495Konig S, Schlereth T, Birklein F. Molecular signature of complex regional pain syndrome (CRPS) and its analysis. Expert Rev Proteomics. 2017 Oct;14(10):857-867. doi: 10.1080/14789450.2017.1366859. Epub 2017 Aug 17.
- Background: PubMed 20493633Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Chont M, Vatine JJ. Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome. Pain. 2010 Aug;150(2):268-274. doi: 10.1016/j.pain.2010.04.030. Epub 2010 May 20.
- Background: PubMed 22074333Orlova IA, Alexander GM, Qureshi RA, Sacan A, Graziano A, Barrett JE, Schwartzman RJ, Ajit SK. MicroRNA modulation in complex regional pain syndrome. J Transl Med. 2011 Nov 10;9:195. doi: 10.1186/1479-5876-9-195.
- Background: PubMed 11027911Galer BS, Henderson J, Perander J, Jensen MP. Course of symptoms and quality of life measurement in Complex Regional Pain Syndrome: a pilot survey. J Pain Symptom Manage. 2000 Oct;20(4):286-92. doi: 10.1016/s0885-3924(00)00183-4.
- Background: PubMed 26524108Bean DJ, Johnson MH, Heiss-Dunlop W, Kydd RR. Extent of recovery in the first 12 months of complex regional pain syndrome type-1: A prospective study. Eur J Pain. 2016 Jul;20(6):884-94. doi: 10.1002/ejp.813. Epub 2015 Nov 2.
- Background: PubMed 25803756Bean DJ, Johnson MH, Heiss-Dunlop W, Kydd RR. Factors Associated With Disability and Sick Leave in Early Complex Regional Pain Syndrome Type-1. Clin J Pain. 2016 Feb;32(2):130-8. doi: 10.1097/AJP.0000000000000234.
- Background: PubMed 26133727Bean DJ, Johnson MH, Heiss-Dunlop W, Lee AC, Kydd RR. Do psychological factors influence recovery from complex regional pain syndrome type 1? A prospective study. Pain. 2015 Nov;156(11):2310-2318. doi: 10.1097/j.pain.0000000000000282.
- Background: PubMed 29545626Birklein F, Ajit SK, Goebel A, Perez RSGM, Sommer C. Complex regional pain syndrome - phenotypic characteristics and potential biomarkers. Nat Rev Neurol. 2018 May;14(5):272-284. doi: 10.1038/nrneurol.2018.20. Epub 2018 Mar 16.
- Background: PubMed 25505484Le Carre J, Lamon S, Leger B. Validation of a multiplex reverse transcription and pre-amplification method using TaqMan((R)) MicroRNA assays. Front Genet. 2014 Nov 26;5:413. doi: 10.3389/fgene.2014.00413. eCollection 2014.
- Individual participant dataSharing planned: Undecided. Protocol of the study
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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.
Bertrand Léger, PhD study director
institut de recherche en réadaptatation
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 Syndrome Type I, run by Clinique Romande de Readaptation at 1 site in Switzerland.
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 7 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: finished, as of the sponsor's last update on 30 Sep 2026. 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 Switzerland. 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?
patient return to work (RTW) (time frame: 3 months after inclusion). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04703647, which also lists 9 linked publications.
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 30 Sep 2026.