Adrenocorticotropic Axis and Neuropathic Pain (HORMONES)
August 5, 2026 updated by: University Hospital, Clermont-Ferrand
Status of the Hypothalamic-pituitary-gonado- Adrenal Axis (HHSG) in Patients With Neuropathic Pain
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Day of inclusion: Blood sample for analysis of several hormones (cortisol, ACTH, SHBG, total testostérone et S-DHEA, βœstradiol et progestérone for women, LH, FSH).
Day +1: salivary samples (at wake-up, 30 minutes after wake-up, at lunch, at 06:00 pm and before sleep).
Day +2: salivary samples (at wake-up, 30 minutes after wake-up).
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
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,
Description
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,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
hormonal status of neuropathic patients (blood sample )
Time Frame: at day 0
|
at day 0
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
hormonal status of neuropathic patients, salivary sample
Time Frame: at day 1 and 2
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at day 1 and 2
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Collection of different drug classes (antidepressants, antiepileptics, opioids)
Time Frame: at day 0,
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at day 0,
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|
scale anxiety / depression HAD
Time Frame: at day 0
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at day 0
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cognitive state
Time Frame: at day 0,
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at day 0,
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SF36 questionnaire
Time Frame: at day 0
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at day 0
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physical activity questionnaire (IPAQ)
Time Frame: at day 0
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at day 0
|
|
body mass index (BMI / Impedancemetry)
Time Frame: at day 0
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at day 0
|
|
waist circumference
Time Frame: at day 0
|
at day 0
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gisèle PICKERING, University Hospital, Clermont-Ferrand
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
February 28, 2012
First Submitted That Met QC Criteria
March 2, 2012
First Posted (Estimated)
March 5, 2012
Study Record Updates
Last Update Posted (Actual)
August 10, 2026
Last Update Submitted That Met QC Criteria
August 5, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0116
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.