Adrenocorticotropic Axis and Neuropathic Pain

NCT01543425 | Completed

• 1 other identifier: CHU-0116
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Pain

Keywords

Neuropathic Pain; Adenocorticotrophic axis; Psychological state

Outcome Measures

Primary Outcomes (1)

• hormonal status of neuropathic patients (blood sample )

  at day 0

Secondary Outcomes (8)

• hormonal status of neuropathic patients, salivary sample

  at day 1 and 2

• Collection of different drug classes (antidepressants, antiepileptics, opioids)

  at day 0,

• scale anxiety / depression HAD

  at day 0

• cognitive state

  at day 0,

• SF36 questionnaire

  at day 0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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,

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

• Corriger A, Duclos M, Corcuff JB, Lambert C, Marceau G, Sapin V, Macian N, Roux D, Pereira B, Pickering G. Hormonal Status and Cognitivo-Emotional Profile in Real-Life Patients With Neuropathic Pain: A Case Control Study. Pain Pract. 2019 Sep;19(7):703-714. doi: 10.1111/papr.12800. Epub 2019 Jun 27.

  PMID: 31127700 DERIVED

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).

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gisèle PICKERING

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 5, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

FR (1)