CannabisRIC: Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Completed

CT.gov ID

NCT04402554

Collaborator

(none)

501

Enrollment

Location

Actual Duration (Months)

50.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis	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 Design

Study Type:

Observational

Actual Enrollment :

501 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis

Actual Study Start Date :

May 19, 2020

Actual Primary Completion Date :

Mar 19, 2021

Actual Study Completion Date :

Mar 19, 2021

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of patients with problematic cannabis use [Day 0]
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
Assessing the association between cannabis use and disease activity of spondylitis ankylosing [Day 0]
Spondylitis ankylosing activity was assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questionnaire.
Assessing the association between cannabis use and disease activity of rheumatoid arthritis / psoriatic arthritis [Day 0]
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.
Assessing the association between cannabis use and functional disability [Day 0]
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
Assessing the association between cannabis use and Anxiety/Depression [Day 0]
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.
Assessing the association between cannabis use and pain catastrophism [Day 0]
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.
Assessing the association between cannabis use and social vulnerability [Day 0]
level of social vulnerability was assessed by Assessment of Precariousness and Health Inequalities in Health Examination Centers (EPICES) questionnaire. .