CompletedNot Applicable

Adrenocorticotropic Axis and Neuropathic Pain

France120 participantsStarted 2012-03

Plain-language summary

Chronic pain is often associated with a chronic stress and HHSG axis plays a pivotal role in maintaining homeostasis. The literature reports that pain in patients treated with opioids, significant changes are taking place in this axis with a collapse in hormone concentrations that are correlated with the decline on tests of quality of life and psychological testing. The investigators hypothesis is that this "endocrinopathy" could also be present in patients treated for neuropathic pain with other drug classes as opiates (antidepressants, antiepileptics), and may explain, at least in part, the impairement of the quality of life of these patients.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Group of patients * Patients older than 18 years, * Male or Female with BMI between 18 and 35, * Patients with chronic neuropathic pain for more than six months, except to diabetes or central neuropathic pain * Patients receiving systemic therapy for treating chronic neuropathic pain such as antidepressants, anticonvulsants or opiates for at least 6 months. Group of healthy volunteers * non-painful healthy volunteers matched by age, sex, BMI and menopausal status for women, * Free of analgesics within 8 days before the test, * Aged over 18 years, * Male or Female, Exclusion Criteria: * Subjects with a medical history and / or surgical judged by the investigator or his representative as being incompatible with the test * Patients treated only by topical treatment (lidocaine patch only for example) * Pateints receiving corticosteroid treatment at the time of enrollment, or who received such treatment during the last 6 months (regardless of the dosage form and dosage), * Inflammatory and evolutive pathology requiring long term treatment, * Type 2 diabetes, * Postmenopausal women with replacement therapy, * Weight change of more than 5% within 3 months before the study, * BMI \<18 or\> 35,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

hormonal status of neuropathic patients (blood sample )

Timeframe: at day 0

Trial details

NCT IDNCT01543425

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-02

View on ClinicalTrials.gov More Neuropathic Pain trials