Adrenocorticotropic Axis and Neuropathic Pain

Neuropathic Pain Clinical Trial

— HORMONES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543425
• Other study ID #: CHU-0116
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: May 13, 2013
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Pharmacologic center of the Hospital of Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hormonal status of neuropathic patients (blood sample )		at day 0	Yes
Secondary	hormonal status of neuropathic patients, salivary sample		at day 1 and 2	Yes
Secondary	Collection of different drug classes (antidepressants, antiepileptics, opioids)		at day 0,	Yes
Secondary	scale anxiety / depression HAD		at day 0	Yes
Secondary	cognitive state		at day 0,	Yes
Secondary	SF36 questionnaire		at day 0	Yes
Secondary	physical activity questionnaire (IPAQ)		at day 0	Yes
Secondary	body mass index (BMI / Impedancemetry)		at day 0	Yes
Secondary	waist circumference		at day 0	Yes