UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062531 |
|---|---|
| Receipt number | R000071585 |
| Scientific Title | A prospective study to quantify pain and pain threshold using a sensory and pain quantitative analyzer (Pain Vision) in patients with adrenal insufficiency of all etiologies |
| Date of disclosure of the study information | 2026/08/10 |
| Last modified on | 2026/08/09 23:18:02 |
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Basic information
Public title
Study to investigate pain sensitivity in patients with adrenal insufficiency
Acronym
Pain Assessment in Adrenal Insufficiency
Scientific Title
A prospective study to quantify pain and pain threshold using a sensory and pain quantitative analyzer (Pain Vision) in patients with adrenal insufficiency of all etiologies
Scientific Title:Acronym
Prospective Pain Vision Assessment in Adrenal Insufficiency
Region
| Japan |
Condition
Condition
Adrenal insufficiency
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess pain in patients with adrenal insufficiency using Pain Vision, a minimally invasive, simple, quantitative, and objective method for pain evaluation. This study
will compare pain among patients with different clinical backgrounds, evaluate treatment-related changes in pain, and explore optimal hormone replacement therapy for patients with adrenal insufficiency.
Basic objectives2
Others
Basic objectives -Others
Objective and quantitative evaluation of pain and pain threshold, and elucidation of the pathophysiology in patients with adrenal insufficiency
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in the change in pain threshold measured by Pain Vision before and after treatment for adrenal insufficiency
Key secondary outcomes
In the subgroup of patients with adrenal insufficiency presenting with arthralgia or myalgia, the secondary outcomes will include changes in pain-compatible current measured by Pain Vision for the same
pain before and after treatment, background factors associated with changes in pain threshold and pain-compatible current, and differences in changes assessed by Pain Vision and the visual analog scale
(VAS).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with adrenal insufficiency or suspected adrenal insufficiency who are scheduled to be admitted to our department, aged 20 years or older and younger than 80 years, regardless of sex.
Key exclusion criteria
Patients who did not provide informed consent; patients with concomitant conditions that may cause peripheral neuropathy (eg, diabetes mellitus or current or previous treatment with chemotherapy
associated with peripheral neuropathy).
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Hishida |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
+81-44-977-8111
y.hishida@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Hishida |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
+81-44-977-8111
Homepage URL
y.hishida@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bioethics Committee (Clinical Trial Subcommittee), St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
Tel
+81-44-977-8111
k-sienbu.mail@marianna-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In eligible participants, pain threshold will be measured using Pain Vision at admission, together with visual analogue scale (VAS) assessment. In those with arthralgia or myalgia, pain-equivalent current will also be measured. If glucocorticoid therapy must be started before admission because of severe symptoms, the initial Pain Vision and VAS assessments will be performed at the outpatient visit before treatment.
Based on endocrine testing during hospitalization, participants in whom adrenal insufficiency is ruled out will be classified into the control group, whereas those diagnosed with adrenal insufficiency, including those with a pre-existing diagnosis, will be classified into the adrenal insufficiency group. The control group is used because patients evaluated for suspected adrenal insufficiency may have other endocrine disorders affecting pain threshold or peripheral nerve function, and pain measures may also change during hospitalization.
A second Pain Vision and VAS assessment will be performed at a post-discharge outpatient visit in both groups. In the adrenal insufficiency group, glucocorticoid replacement will be initiated as routine clinical care before discharge, allowing assessment of changes in pain threshold and pain-equivalent current after treatment.
The primary outcome is the between-group difference in change in Pain Vision pain threshold from the first to the second assessment. Secondary outcomes include change in pain-equivalent current in participants with arthralgia or myalgia, factors associated with changes in pain measures, and differences in changes assessed by Pain Vision and VAS.
Management information
Registered date
| 2026 | Year | 08 | Month | 09 | Day |
Last modified on
| 2026 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071585
