NCT04402554

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

May 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2021

Completed
Last Updated

June 2, 2021

Status Verified

June 1, 2021

Enrollment Period

10 months

First QC Date

May 15, 2020

Last Update Submit

June 1, 2021

Conditions

Rheumatoid ArthritisAnkylosing SpondylitisPsoriatic Arthritis

Keywords

CannabisCannabis/therapeutic useCannabis/therapyMedical MarijuanaChronic PainRheumatic DiseasesArthritis, RheumatoidSpondylitis, AnkylosingArthritis, Psoriatic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Percentage of patients with problematic cannabis use

    Day 0

  • Assessing the association between cannabis use and disease activity of spondylitis ankylosing

    Day 0

  • Assessing the association between cannabis use and disease activity of rheumatoid arthritis / psoriatic arthritis

    Day 0

  • Assessing the association between cannabis use and functional disability

    Day 0

  • Assessing the association between cannabis use and Anxiety/Depression

    Day 0

  • +2 more secondary outcomes

Interventions

Cannabis questionnaireBEHAVIORAL

The effectiveness and use of cannabis in the management of chronic pain has been well known for many years, but has so far been illegal and therefore largely unacknowledged. We hypothesize that the use of cannabis in this population of patients with chronic joint or spinal pain is not anecdotal and responds to a need to further improve the overall management of patients. The objective of our anonymous questionnaire is to estimate the prevalence of cannabis use in patients with chronic inflammatory rheumatism.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Arthritis, RheumatoidSpondylitis, AnkylosingArthritis, PsoriaticMarijuana AbuseChronic PainRheumatic Diseases

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesAxial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesAnkylosisPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSubstance-Related DisordersChemically-Induced DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sylvain Mathieu

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 27, 2020

Study Start

May 19, 2020

Primary Completion

March 19, 2021

Study Completion

March 19, 2021

Last Updated

June 2, 2021

Record last verified: 2021-06

Locations

FR(1)