OsteoarthritisMEDUSANCT06224959
Migraine and Neuropathic Pain in Osteoarthritis
An observational study of Osteoarthritis and Migraine, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Migraine, Neuropathic Pain
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2024to 27 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- patients over 18 years old
- patients with articular or/and spinal osteoarthritis
- affiliation to a social security system.
- able to read and understand french
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, France
Lise Laclautre
About this study
Official title: Prevalence of Migraine and Neuropathic Pain in Osteoarthritis: Multicenter, Multidisciplinary, Cross-sectional Epidemiological Study.
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.
Read the detailed 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.
- Conditions
- Osteoarthritis, Migraine, Neuropathic Pain
- Keywords
- osteoarthritis, migraine, neuropathic pain
- Medical subject headings
- Osteoarthritis, Migraine Disorders, Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 :
- At least five seizures meeting criteria B through D.
- Headache attacks lasting 4 to 72 hours (without treatment).
- 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
- At least one of the following during the headache :nausea and/or vomiting; photophobia and phonophobia.
- Clinical examination should be normal between attacks. In case of doubt, an organic disorder must be excluded by appropriate additional investigations.
Measured: 10 minutes
Secondary outcomes (3)
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.
Measured: 10 minutes
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.
Measured: 10 minutes
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start27 Mar 2024
- Primary completion27 Mar 2028 (estimated)
- Study completion27 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain MATHIEU, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224959
- Sponsor's protocol ID
- RNI 2023 MATHIEU
- Other IDs
- 2023-A00093-42
- Acronym
- MEDUSA
- Status last verified
- Mar 2025
- First submitted
- 8 Jan 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Migraine and Neuropathic Pain in Osteoarthritis: Multicenter, Multidisciplinary, Cross-sectional Epidemiological Study.
- ClinicalTrials.gov ID
- NCT06224959
- Acronym / sponsor ID
- MEDUSA / RNI 2023 MATHIEU
- Conditions
- Osteoarthritis, Migraine, Neuropathic Pain
- Keywords
- osteoarthritis, migraine, neuropathic pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 27 Mar 2028 (estimated)
- Study completion
- 27 Mar 2028 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- patients over 18 years old
- patients with articular or/and spinal osteoarthritis
- affiliation to a social security system.
- able to read and understand french
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the presence of neuropathic pain in patients
Time frame: 10 minutes
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.
the presence of migraine in patients
Time frame: 10 minutes
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.
3 secondary outcomes
the presence of anxiety and depression symptoms in patients
Time frame: 10 minutes
measure the level of catastrophizing thoughts related to pain in patients
Time frame: 10 minutes
Impact of headhache in patients
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sylvain MATHIEU principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Migraine, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the presence of neuropathic pain in patients (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.