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Adrenocorticotropic Axis and Neuropathic Pain (HORMONES)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01543425
First Posted: March 5, 2012
Last Update Posted: May 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pharmacologic center of the Hospital of Clermont-Ferrand
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  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

Resource links provided by NLM:


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 ]

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01543425     History of Changes
Other Study ID Numbers: CHU-0116
First Submitted: February 28, 2012
First Posted: March 5, 2012
Last Update Posted: May 14, 2013
Last Verified: May 2013

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


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