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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027087
Receipt No. 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

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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
Email 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
Email masui@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

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
Email

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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030909

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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