Adrenocorticotropic Axis and Neuropathic Pain (HORMONES)

This study has been completed.
Sponsor:
Collaborator:
Pharmacologic center of the Hospital of Clermont-Ferrand
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01543425
First received: February 28, 2012
Last updated: May 13, 2013
Last verified: May 2013

February 28, 2012
May 13, 2013
March 2012
February 2013   (final data collection date for primary outcome measure)
hormonal status of neuropathic patients (blood sample ) [ Time Frame: at day 0 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01543425 on ClinicalTrials.gov Archive Site
  • hormonal status of neuropathic patients, salivary sample [ Time Frame: at day 1 and 2 ] [ Designated as safety issue: Yes ]
  • Collection of different drug classes (antidepressants, antiepileptics, opioids) [ Time Frame: at day 0, ] [ Designated as safety issue: Yes ]
  • scale anxiety / depression HAD [ Time Frame: at day 0 ] [ Designated as safety issue: Yes ]
  • cognitive state [ Time Frame: at day 0, ] [ Designated as safety issue: Yes ]
  • SF36 questionnaire [ Time Frame: at day 0 ] [ Designated as safety issue: Yes ]
  • physical activity questionnaire (IPAQ) [ Time Frame: at day 0 ] [ Designated as safety issue: Yes ]
  • body mass index (BMI / Impedancemetry) [ Time Frame: at day 0 ] [ Designated as safety issue: Yes ]
  • waist circumference [ Time Frame: at day 0 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Adrenocorticotropic Axis and Neuropathic Pain
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.

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).

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   None Retained
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).

Non-Probability Sample

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,
Neuropathic Pain
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2013
February 2013   (final data collection date for primary outcome measure)

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,
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01543425
CHU-0116
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
Pharmacologic center of the Hospital of Clermont-Ferrand
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP