UMIN-CTR Clinical Trial

Public title

Does Mechanical Diagnosis and Therapy change the habitual lumbopelvic posture and time of sitting in individuals with low back pain: a pilot study

Acronym

Does Mechanical Diagnosis and Therapy change the habitual lumbopelvic posture and time of sitting in individuals with low back pain: a pilot study

Scientific Title

Does Mechanical Diagnosis and Therapy change the habitual lumbopelvic posture and time of sitting in individuals with low back pain: a pilot study

Scientific Title:Acronym

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

Low back pain

Classification by specialty

Orthopedics

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Takasaki

Organization

Saitama Prefectural University

Division name

Physical Therapy

Zip code

Address

Sannomiya 820, Koshigaya, Saitama

TEL

0489734706

Email

takasaki-hiroshi@spu.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroshi Takasaki

Organization

Saitama Prefectural University

Division name

Physical Therapy

Zip code

Address

Sannomiya 820, Koshigaya, Saitama

TEL

0489734706

Homepage URL

Email

takasaki-hiroshi@spu.ac.jp

Institute

Saitama Prefectural University

Institute

Department

Personal name

Organization

Japan Society for the promotion of science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

青木中央クリニック（埼玉県）

Date of disclosure of the study information

2016

Year

10

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

10

Month

05

Day

Date of IRB

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

Other related information

Registered date

2016

Year

10

Month

04

Day

Last modified on

2018

Year

04

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027977