UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027087 |
|---|---|
| Receipt number | R000030909 |
| Scientific Title | Evaluation of endogenous analgesia in patients with chronic low back pain |
| Date of disclosure of the study information | 2017/04/25 |
| Last modified on | 2018/09/12 14:33:45 |
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Basic information
Public title
Evaluation of endogenous analgesia in patients with chronic low back pain
Acronym
Evaluation of endogenous analgesia in patients with chronic low back pain
Scientific Title
Evaluation of endogenous analgesia in patients with chronic low back pain
Scientific Title:Acronym
Evaluation of endogenous analgesia in patients with chronic low back pain
Region
| Japan |
Condition
Condition
chronic low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endogenous analgesic system plays an important role when the excessive pain is applied to the body. It involves descending pain inhibitory system and endogenous opioid. Dysfunction of the endogenous analgesic system causes chronic pain. Low back pain has a large number of affected patients, so establishment of appropriate low back pain treatment is required. It has been reported that the function of the endogenous analgesic system is decreased in various chronic pain patients including chronic arthralgia (Lewis et al., J Pain 2012; 10: 936-44.). In these cases, the medicine that activates the endogenous analgesic system is considered to be suitable as a treatment. However, there have been no reports that evaluate the function of the endogenous analgesic system of patients with chronic low back pain. In this study, we will evaluate the function of endogenous analgesic system of chronic low back pain patients. If the dysfunction of endogenous analgesic system is revealed, new evidence-based therapies can be established.
Basic objectives2
Others
Basic objectives -Others
we will evaluate the function of endogenous analgesic system of chronic low back pain patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of Numerical Rating Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
conditioned pain modulation
test stimulation1:pressure, 30 seconds
condition stimulation :cold water, 1 minutes
test stimulation2:pressure, 30 seconds
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients:30 patients with chronic low back pain .
Control: 30 healthy volunteers.
Informed concent is essential.
Key exclusion criteria
1. Healthy volunteers cannot have any chronic pain.
2. Who cannnot understand the protocol of this study because of psyciatric disorder or dimentia.
3. Who cannot tolerate the stimulation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Obata |
Organization
Fukushima Medical University
Division name
Center for Pain Management, Department of Anesthesiology
Zip code
Address
Hikarigaoka 1, Fukushima-City, Fukushima-Pref, JAPAN
TEL
024-547-1111
stoppain@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Nakano |
Organization
Fukushima Medical University
Division name
Department of Anesthesiology
Zip code
Address
Hikarigaoka 1, Fukushima-City, Fukushima-Pref, JAPAN
TEL
024-547-1111
Homepage URL
masui@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
福島県立医科大学附属病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 21 | Day |
Last modified on
| 2018 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030909
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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