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OpenTrials
Completed

NCT Number: NCT01543425

Adrenocorticotropic Axis and 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Primary outcomes

  1. hormonal status of neuropathic patients (blood sample )

    Time frame: at day 0

Secondary outcomes

  1. hormonal status of neuropathic patients, salivary sample

    Time frame: at day 1 and 2

  2. Collection of different drug classes (antidepressants, antiepileptics, opioids)

    Time frame: at day 0,

  3. scale anxiety / depression HAD

    Time frame: at day 0

  4. cognitive state

    Time frame: at day 0,

  5. SF36 questionnaire

    Time frame: at day 0

  6. physical activity questionnaire (IPAQ)

    Time frame: at day 0

  7. body mass index (BMI / Impedancemetry)

    Time frame: at day 0

  8. waist circumference

    Time frame: at day 0

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: HORMONES

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 5, 2012
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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