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

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 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


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

Value
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