Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis (CannabisRIC)

Patients with inflammatory rheumatism very often have residual pain that is not easily relieved by conventional treatments. They can then use non-drug methods, such as physiotherapy, hypnosis or even cannabis.

The aim of this study is to assess the percentage of patients who use cannabis to better relieve their pain or anxiety in chronic inflammatory rheumatism.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis
• Intervention / Treatment: Behavioral: Cannabis questionnaire

Detailed Description

Thanks to a better understanding of the pathophysiological mechanisms of inflammatory rheumatism, rheumatology has known for several decades a growth in its therapeutic arsenal (csDMARDs, bDMARDs, tDMARDs). rheumatism control has thus been optimized.

however, patients very often keep pain, anxiety, residual fatigue, poorly controlled by our conventional therapies. patients then turn to non-drug therapies, among which the use of cannabis.

endocannabinoids have an analgesic and anti-inflammatory action recognized in pre-clinical trials. however, investigators currently lack the data to authorize its use in clinical rheumatology.

the aim of this study is to determine the prevalence of cannabis users in patients with rheumatoid arthritis, ankylosing spondyloarthritis or psoriatic arthritis in our unit. as a second intention, investigators will refine the consumption characteristics. Investigators will also look for possible risk factors for consumption (sensitivity to pain, catastrophism, standard of living, anxiety, depression, rheumatic activity and quality of life).

• Study Type: Observational
• Enrollment (Actual): 501

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with Chronic Inflammatory Rheumatism, whether rheumatoid arthritis or spondyloarthritis, seen in consultation in the department of Rheumatology

Description

Inclusion Criteria:

• Rheumatoid Arthritis (ACR 2010 Criteria)
• Ankylosing Spondylitis (New york or ASAS criteria)
• Psoriatic Arthritis (CASPAR criteria)

Exclusion Criteria:

• Patient unable to complete questionnaires or unable to express informed consent
• Guardianship, trusteeship, deprivation of liberties, safeguard of justice

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of cannabis use in patients with chronic inflammatory rheumatic conditions	Patients will answer the following question: Are you currently using cannabis - Yes or No	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with problematic cannabis use	Questionnaire CAST score. It includes 6 items with answer modes coded from 0 to 4. The total score obtained by summing these 6 items can therefore vary from 0 to 24. We define users without risk for a score of less than 3, users with low risk for a score greater than or equal to 3 and less than 7, and finally those with a risk of problematic use for a score greater than or equal to 7	Day 0
Assessing the association between cannabis use and disease activity of spondylitis ankylosing	Spondylitis ankylosing activity was assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questionnaire.	Day 0
Assessing the association between cannabis use and disease activity of rheumatoid arthritis / psoriatic arthritis	Rheumatoid arthritis / psoriatic arthritis was assessed by Disease Activity Score including 28 joints (DAS 28). DAS 28 includes the 28 swollen joint count (28 SJC) + the 28 tender joint count (28 TJC) + patient global assessments of disease activity on a VAS, + ESR or CRP. [DAS (VS) = 0,56 x √TJC + 0,28 x √SJC + 0,7 x ln(VS) + 0,014 x VAS ; DAS (CRP) = 0,56 x √TJC + 0,28 x √SJC + 0,36 x ln(CRP + 1) + 0,014 x VAS + 0,96 ]. The scores according to EULAR criteria are: ≤2.6 for remission, >2.6 and ≤3.2 for low disease activity, >3.2 and ≤5.1 for moderate disease activity and >5.1 for high disease activity.	Day 0
Assessing the association between cannabis use and functional disability	Functional disability was assessed by Health Assessment Questionnaire Disability Index (HAQ DI). HAQ-DI is an index that measures the impact of pathology on everyday activities such as dressing, eating, walking, etc. The following note is allocated to each question: 0 = without any difficulty ; 1 = with some difficulty ; 2 = with great difficulty ; 3 = unable to do so	Day 0
Assessing the association between cannabis use and Anxiety/Depression	Anxiety and depression was assessed by Hospital Anxiety and Depression scale (HADs). 14 items scored from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), allowing two scores to be obtained (maximum score of each score = 21). To detect anxious and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D): - 7 or less: absence of symptoms - 8 to 10: doubtful symptoms - 11 and more: certain symptoms.	Day 0
Assessing the association between cannabis use and pain catastrophism	Catastrophism was assessed by Pain catastrophisme scale (PCS). PCS is a thirteen-item scale to identify and quantify the extent of catastrophism in a painful patient. Three subgroups group together the criteria related to rumination (items 8,9,10,11), exaggeration (items 6,7,13) and vulnerability (items 1,2,3,4,5,12) . Patients are asked to rate their personal experience using a five-point rating from 0 to 4. The final score can therefore vary from 0 to 52. A PCS score of 30 or more represents a relevant clinical level of catastrophism.	Day 0
Assessing the association between cannabis use and social vulnerability	level of social vulnerability was assessed by Assessment of Precariousness and Health Inequalities in Health Examination Centers (EPICES) questionnaire. .	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Sylvain Mathieu, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 19, 2020
• Primary Completion (ACTUAL): March 19, 2021
• Study Completion (ACTUAL): March 19, 2021

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Chronic Pain; Rheumatic Diseases; Cannabis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Medical Marijuana; Cannabis/therapeutic use; Cannabis/therapy
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Skin Diseases; Infections; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Psoriasis; Bone Diseases, Infectious; Ankylosis; Arthritis; Marijuana Abuse; Arthritis, Psoriatic; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: RNI 2020 MATHIEU; 2020-A00473-36 (OTHER: 2020-A00473-36)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No