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
  Purpose

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.


Condition
Neuropathic Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Status of the Hypothalamic-pituitary-gonado- Adrenal Axis (HHSG) in Patients With Neuropathic Pain

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • hormonal status of neuropathic patients (blood sample ) [ Time Frame: at day 0 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

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).


Enrollment: 120
Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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,
Criteria

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,
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01543425

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Pharmacologic center of the Hospital of Clermont-Ferrand
Investigators
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01543425     History of Changes
Other Study ID Numbers: CHU-0116
Study First Received: February 28, 2012
Last Updated: May 13, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Neuropathic Pain
Adenocorticotrophic axis
Psychological state

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014