UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006250
Receipt number R000007397
Scientific Title The Effectiveness of AKA-Hakata Method for Chronic Low Back Pain;A Randomized Controlled Trial
Date of disclosure of the study information 2011/08/30
Last modified on 2018/05/11 07:53:49

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Basic information

Public title

The Effectiveness of AKA-Hakata Method for Chronic Low Back Pain;A Randomized Controlled Trial

Acronym

The effectiveness of AKA-Hakata Method for Chronic Low Back Pain

Scientific Title

The Effectiveness of AKA-Hakata Method for Chronic Low Back Pain;A Randomized Controlled Trial

Scientific Title:Acronym

The effectiveness of AKA-Hakata Method for Chronic Low Back Pain

Region

Japan


Condition

Condition

Chronic Low Back Pain

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effectiveness of AKA-Hakata Metod for Chronic Low Back Pain

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

VAS(Visual Analogue Scale)
RDQ(Roland-Morris Disability Questionnaire)
sf-36(36-Item Short-Form Health Survey)

Key secondary outcomes

SDS(Self Depression Scale)
d-ROM(d-Reactive Oxygen Metabolites) BAP(Biological Antioxydant Potential)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

AKA-H group (HG)

Interventions/Control_2

Control group (CG:using sham technique of AKA-H )

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

12 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who have had low back pain lasting more than 6 months,have received orthopedic treatment.

Key exclusion criteria

1.Patient who had spine/spinal cord neoplasm, infection, and fracture (compression fracture)
2.Patient who had operation for lumbar spine within 6 months before the day of agreement to enter the trial.
3.Patient who had severe osteoporosis.
4.Inadequate patient,who is decided by a doctor,for participation or execution.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Kogure

Organization

Sakura Orthopedic Hospital

Division name

Department of Rehabilitation

Zip code


Address

Osakidai 4-3-5 , Sakura City, Chiba,

TEL

+81-43-483-2552

Email

anakin_kogure@ybb.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Kogure

Organization

Saitama Prefectural Rehabilitation Center

Division name

Department of Rehabilitation

Zip code


Address

148-1 Nishi-Kaizuka, Ageo City, Saitama Prefecture

TEL

048-781-2222

Homepage URL


Email

anakin_kogure@ybb.ne.jp


Sponsor or person

Institute

Japanese Medical Society of Arthrokinematic Approach

Institute

Department

Personal name



Funding Source

Organization

Japanese Medical Society of Arthrokinematic Approach

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Jichi Medical Univercity

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

埼玉県総合リハビリテーションセンター(Saitama Prefectural Rehabilitation Center )


Other administrative information

Date of disclosure of the study information

2011 Year 08 Month 30 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2007 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2007 Year 01 Month 01 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

2011 Year 08 Month 30 Day

Last modified on

2018 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007397


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name