UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Effectiveness of AKA-Hakata Method for Chronic Low Back Pain;A Randomized Controlled Trial
Title of the study (Brief title)	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	Akira Kogure
Organization	Sakura Orthopedic Hospital
Division name	Department of Rehabilitation
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	Akira Kogure
Organization	Saitama Prefectural Rehabilitation Center
Division name	Department of Rehabilitation
Address	148-1 Nishi-Kaizuka, Ageo City, Saitama Prefecture
TEL	048-781-2222
Homepage URL
Email	anakin_kogure@ybb.ne.jp

Sponsor
Institute	Japanese Medical Society of Arthrokinematic Approach
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2007 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007397