Neuropathic PainHORMONESNCT01543425
Adrenocorticotropic Axis and Neuropathic Pain
An observational study of Neuropathic Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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,
Who may be able to join
- 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
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- 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,
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Neuropathic Pain
- Keywords
- Neuropathic Pain, Adenocorticotrophic axis, Psychological state
- Medical subject headings
- Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
hormonal status of neuropathic patients (blood sample )
Measured: at day 0
Secondary outcomes (8)
hormonal status of neuropathic patients, salivary sample
Measured: at day 1 and 2
Collection of different drug classes (antidepressants, antiepileptics, opioids)
Measured: at day 0,
scale anxiety / depression HAD
Measured: at day 0
cognitive state
Measured: at day 0,
SF36 questionnaire
Measured: at day 0
physical activity questionnaire (IPAQ)
Measured: at day 0
body mass index (BMI / Impedancemetry)
Measured: at day 0
waist circumference
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543425
- Sponsor's protocol ID
- CHU-0116
- Acronym
- HORMONES
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2012
- Last updated
- 10 Aug 2026
- Results posted
- No
Publications
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.
PubMed 31127700
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Status of the Hypothalamic-pituitary-gonado- Adrenal Axis (HHSG) in Patients With Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01543425
- Acronym / sponsor ID
- HORMONES / CHU-0116
- Conditions
- Neuropathic Pain
- Keywords
- Neuropathic Pain, Adenocorticotrophic axis, Psychological state
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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,
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hormonal status of neuropathic patients (blood sample )
Time frame: at day 0
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Results publication: PubMed 31127700Corriger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisèle PICKERING principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hormonal status of neuropathic patients (blood sample ) (time frame: at day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01543425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.