UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Does Mechanical Diagnosis and Therapy change the habitual lumbopelvic posture and time of sitting in individuals with low back pain: a pilot study
Title of the study (Brief title)	Does Mechanical Diagnosis and Therapy change the habitual lumbopelvic posture and time of sitting in individuals with low back pain: a pilot study
Region	Japan

Condition
Condition	Low back pain
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study will be to preliminarily investigate if interventions based on Mechanical Diagnosis and Therapy (MDT) changes habitual lumbopelvic posture and time of sitting in individual with low back pain, who have reduction of symptoms by mechanical loading in lumbar extension.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Daily posture scores (threshold of very slouched)(%) and time of sitting measured with the LumoBack sensor
Key secondary outcomes	Pain intensity will be assessed with the P4 (0-40). The magnitude of disability will be assessed with the Oswestry Disability Index Japanese version, Patient specific functional scale, and the MOS 36-Item Short-Form Health Survey Japanese version. These assessments will be undertaken before the initial MDT intervention, and at the third and sixth weeks after the initial MDT intervention. Overall improvement will be measured using the Global Perceived Change Scale (GPC) where patients score their perceived change after the treatment on a 7-point scale ranging from: 1 (completely recovered) to 7 (worse than ever) at the third and sixth weeks after the initial MDT intervention.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Participants will wear the LumoBack sensor for one week prior to the initial MDT session. At the initial MDT session, participants will be classified to posterior derangement subgroup or other MDT subgroups. Individuals in the posterior derangement subgroup will keep wearing the LumoBack sensor for six weeks and undertake MDT assessments and treatments for six weeks. The intervention will be undertaken 1-2 times a week. Postural education in sitting will be undertaken by giving an original McKenzie lumbar roll. Individuals in the other MDT subgroups will be excluded from the study.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Individuals with low back pain, who will be referred to physical therapy (exercise therapy and manual therapy) Individuals waiting for MDT management/treatment for more than one week Individuals using a smart phone or a tablet
Key exclusion criteria	Individuals with a history of back surgery Individuals without symptoms reduction or centralization by loading in the direction of lumbar extension
Target sample size	15

Research contact person
Name of lead principal investigator	Hiroshi Takasaki
Organization	Saitama Prefectural University
Division name	Physical Therapy
Address	Sannomiya 820, Koshigaya, Saitama
TEL	0489734706
Email	takasaki-hiroshi@spu.ac.jp

Public contact
Name of contact person	Hiroshi Takasaki
Organization	Saitama Prefectural University
Division name	Physical Therapy
Address	Sannomiya 820, Koshigaya, Saitama
TEL	0489734706
Homepage URL
Email	takasaki-hiroshi@spu.ac.jp

Sponsor
Institute	Saitama Prefectural University
Institute
Department

Funding Source
Organization	Japan Society for the promotion of science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	青木中央クリニック（埼玉県）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 05 Day
Anticipated trial start date	2016 Year 10 Month 22 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 04 Day
Last modified on	2018 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027977