NCT06224959

Brief Summary

The goal of this observational study is to estimate the frequency of neuropathic pain and migraines in a group of patients with osteoarthritis of the knees, hips, hands, spine or other joints. In addition to their usual care for osteoarthritis, participants will complete questionnaires to define migraine and neuropathic pain.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Mar 2024Mar 2028

First Submitted

Initial submission to the registry

January 8, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2028

Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

January 8, 2024

Last Update Submit

March 5, 2025

Conditions

OsteoarthritisMigraineNeuropathic Pain

Keywords

osteoarthritismigraineneuropathic pain

Outcome Measures

Primary Outcomes (2)

  • the presence of neuropathic pain in patients

    Neuropathic pain is defined by a "Douleur Neuropathique" (DN)-4 questionnaire given to the patients, A patient is considered to have characteristics of neuropathic pain if their DN-4 questionnaire score is greater than 4. DN-4 is a questionnaire used to estimate the likelihood of neuropathic pain in patients and to aid in the diagnosis of neuropathic pain. There are 4 items with a total of 10 questions, the patient must answer yes or no to each question and the doctor counts the answers at the end of the questionnaire, 1 for a yes answer and 0 for a no answer, and the sum obtained is the patient's score.

    10 minutes

  • the presence of migraine in patients

    Completing the headache questionnaire of the International Headache Society (IHS). Strict migraine is defined as meeting all the criteria for migraine as defined by the IHS. Probable migraine sufferers are those who meet all but one of the migraine criteria. IHS criteria is defined by : A. At least five seizures meeting criteria B through D. B. Headache attacks lasting 4 to 72 hours (without treatment). C. Headache with at least two of the following features : One-sided; pulsating; moderate or severe; worsened by routine physical activities, such as climbing or descending stairs D. At least one of the following during the headache :nausea and/or vomiting; photophobia and phonophobia. E. Clinical examination should be normal between attacks. In case of doubt, an organic disorder must be excluded by appropriate additional investigations.

    10 minutes

Secondary Outcomes (3)

  • the presence of anxiety and depression symptoms in patients

    10 minutes

  • measure the level of catastrophizing thoughts related to pain in patients

    10 minutes

  • Impact of headhache in patients

    10 minutes

Eligibility Criteria

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

Patients diagnosed with articular and/or spinal osteoarthritis, under the care of the University Hospital of Clermont-Ferrand (Rheumatology, Physical Medicine and Rehabilitation, Sports Medicine, Occupational Health and Environment, Orthopedics), and/or managed by specialized professionals (general practitioners, sports physicians, rheumatologists, rehabilitation specialists, orthopedic surgeons) in private medical practice

You may qualify if:

  • patients over 18 years old
  • patients with articular or/and spinal osteoarthritis
  • affiliation to a social security system.
  • able to read and understand french

You may not qualify if:

  • patients who refuse to participate in the study
  • patients unable to complete self-questionnaires
  • minors or adults under the protection of the law or under the protection of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France, France

RECRUITING

MeSH Terms

Conditions

OsteoarthritisMigraine DisordersNeuralgia

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sylvain MATHIEU

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

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

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 25, 2024

Study Start

March 27, 2024

Primary Completion (Estimated)

March 27, 2028

Study Completion (Estimated)

March 27, 2028

Last Updated

March 10, 2025

Record last verified: 2025-03

Locations

FR(1)