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Adrenocorticotropic Axis and Neuropathic Pain

Status of the Hypothalamic-pituitary-gonado- Adrenal Axis (HHSG) in Patients With Neuropathic Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01543425
Acronym
HORMONES
Enrollment
120
Registered
2012-03-05
Start date
2012-03-01
Completion date
2013-05-01
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain

Keywords

Neuropathic Pain, Adenocorticotrophic axis, Psychological state

Brief 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.

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).

Interventions

None listed

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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,

Design outcomes

Primary

MeasureTime frame
hormonal status of neuropathic patients (blood sample )at day 0

Secondary

MeasureTime frame
hormonal status of neuropathic patients, salivary sampleat day 1 and 2
Collection of different drug classes (antidepressants, antiepileptics, opioids)at day 0,
scale anxiety / depression HADat day 0
cognitive stateat day 0,
SF36 questionnaireat day 0
physical activity questionnaire (IPAQ)at day 0
body mass index (BMI / Impedancemetry)at day 0
waist circumferenceat day 0

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGisèle PICKERING

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026