Longitudinal Follow-up Study About Complex Regional Pain Syndrome (CRPS) Patients

NCT04703647 | Unknown

• 1 other identifier: CliniqueRR-20
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Complex Regional Pain Syndrome Type I

Keywords

pain; biopsychosocial model; miRNAs; cytokines; upper limb; lower limb

Outcome Measures

Primary Outcomes (8)

• patient return to work (RTW)

  Percentage of patients return to work at T1

  3 months after inclusion

• patient return to work (RTW)

  Percentage of patients return to work at T2

  6 months after inclusion

• patient return to work (RTW)

  Percentage of patients return to work at T3

  1 year after inclusion

• patient return to work (RTW)

  Percentage of patients return to work at T4

  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.

  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.

  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.

  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.

  2 years after inclusion

Secondary Outcomes (4)

• miRNAs and cytokines profile of patients and control

  at T0 (after inclusion)

• miRNAs and cytokines profile of patients

  3 months after inclusion

• miRNAs and cytokines profile of patients

  6 months after inclusion

• miRNAs and cytokines profile of patients

  1 year after inclusion

Study Arms (2)

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.

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.

Other: Blood samples for control group

Interventions

Administration of questionnaires for prospective group OTHER

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) .

Patients with CRPS type 1: prospective group

Blood samples for prospective group OTHER

Blood samples at T0,T1,T2 and T3.

Patients with CRPS type 1: prospective group

Blood samples for control group OTHER

Blood samples just one time

control group for blood analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Romande de Readaptation: lead

Study Sites (1)

Clinique romande de réadaptation

Sion, Valais, 1950, Switzerland

RECRUITING

Related Publications (9)

• 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.

  PMID: 28803495 BACKGROUND

• Harden 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.

  PMID: 20493633 BACKGROUND

• Orlova 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.

  PMID: 22074333 BACKGROUND

• Galer 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.

  PMID: 11027911 BACKGROUND

• Bean 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.

  PMID: 26524108 BACKGROUND

• Bean 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.

  PMID: 25803756 BACKGROUND

• Bean 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.

  PMID: 26133727 BACKGROUND

• Birklein 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.

  PMID: 29545626 BACKGROUND

• Le 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.

  PMID: 25505484 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

For patients, blood samples will be collected at T0 (beginning of the study), T1 (3 months after T0) and, T2 (6 months after T0) and T3 (1 year after T0) by the study nurse (each time two 7.5 ml S-Monovette® K3 EDTA tubes).The samples will be first coded and then processed in our laboratory. After processing, samples will be stored at -80°C in a secured freezer. MiRNAs and various cytokines will be measured directly in our laboratory in Sion using previous validated protocols. For controls (30 patients) will be collected blood samples just one time for comparison with the patients. These same analysis than patients will be made.

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Pain

Interventions

Blood Specimen Collection; Control Groups

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods

Study Officials

• Bertrand Léger, PhD

  institut de recherche en réadaptatation

  STUDY DIRECTOR

Central Study Contacts

michel Konzelmann, MD

CONTACT

+41 79 314 84 84; michel.konzelmann@crr-suva.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: January 11, 2021
• Study Start: March 14, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2025
• Last Updated: August 22, 2024

Record last verified: 2023-08

Locations

CH (1)