Adrenocorticotropic Axis and Neuropathic Pain

Completed

• Conditions: Neuropathic Pain

• Registration Number: NCT01543425
• Lead Sponsor: University Hospital, Clermont-Ferrand

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).

Study Timeline

• Study First Submitted: 2012-02-28
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Primary Completion: 2013-02
• Status Verified: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hormonal status of neuropathic patients (blood sample )	at day 0

Secondary Outcome Measures

Name	Time	Method
hormonal status of neuropathic patients, salivary sample	at day 1 and 2
Collection of different drug classes (antidepressants, antiepileptics, opioids)	at day 0,
cognitive state	at day 0,
SF36 questionnaire	at day 0
physical activity questionnaire (IPAQ)	at day 0
waist circumference	at day 0
scale anxiety / depression HAD	at day 0
body mass index (BMI / Impedancemetry)	at day 0

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France