Migraine and Neuropathic Pain in Osteoarthritis

Osteoarthritis Clinical Trial

— MEDUSA  

Official title:

Prevalence of Migraine and Neuropathic Pain in Osteoarthritis: Multicenter, Multidisciplinary, Cross-sectional Epidemiological Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06224959
• Other study ID #: RNI 2023 MATHIEU
• Secondary ID: 2023-A00093-42
• Status: Not yet recruiting
• Start date: January 31, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study will be proposed to patients with osteoarthritis who come for their routine consultation. If the patient has no abjection to taking part in the study, the doctor will give them the questionnaires to fill in. The questionnaires are about: perception of pain , depression and anxiety, how patients manage their disease emotionally, migraine, neuropathic pain, functional ability, osteoarthritis assessment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Neuralgia
• Neuropathic Pain
• Osteoarthritis

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	the presence of anxiety and depression symptoms in patients	to evaluate the impact of migraine or/and neuropathic pain in patients with osteoarthritis on anxiety and depression symptoms by the Hospital Anxiety and Depression scale questionnaire (HADs). The HADs questionnaire have 14 items, each item is rated on a scale of 0 to 3, with higher scores associated with the presence and level of symptoms.	10 minutes
Secondary	measure the level of catastrophizing thoughts related to pain in patients	to assess how patients with osteoarthritis perceive and react to pain emotionally because of their migraine or/and neuropathic pain by the Pain Catastrophizing Scale (PCS) questionnaire. The questionnaire have 13 items that assess 3 components of catastrophization pain : exaggeration, rumination and helplessness.	10 minutes
Secondary	Impact of headhache in patients	Headache patients complete the Headache Impact Test (HIT-6), which measures the impact of headaches on daily life. It's a 6-question questionnaire with a choice of 5 answers, with points ranging from 6 to 13 per answer. The scores for each column of each question are added together. The higher the score, the greater the impact of the headache on daily life. Scores range from 36 to 78.	10 minutes