UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018380
Receipt number R000021285
Scientific Title Randomized control trail to investigate if treatment effect for low back pain is enhanced by using LumoBack in addition to the McKenzie approach
Date of disclosure of the study information 2015/08/01
Last modified on 2018/04/05 09:08:49

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Basic information

Public title

Randomized control trail to investigate if treatment effect for low back pain is enhanced by using LumoBack in addition to the McKenzie approach

Acronym

Effectiveness of interventions based on Mechanical Diagnosis and Therapy (MDT) and based on MDT with a posture biofeedback device, LumoBack, for non-specific low back pain: a randomized control trial

Scientific Title

Randomized control trail to investigate if treatment effect for low back pain is enhanced by using LumoBack in addition to the McKenzie approach

Scientific Title:Acronym

Effectiveness of interventions based on Mechanical Diagnosis and Therapy (MDT) and based on MDT with a posture biofeedback device, LumoBack, for non-specific low back pain: a randomized control trial

Region

Japan


Condition

Condition

Non-specific 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 investigate if interventions based on Mechanical Diagnosis and Therapy (MDT) with posture feedback device provides a better treatment effect than interventions based on MDT only for those with non-specific 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

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. 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).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Participants in the MDT only group will be treated with routine MDT assessments and treatments for 6 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.

Interventions/Control_2

Participants in the MDT+LumoBack group will be treated with routine MDT assessments and treatments for 6 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. Further, the participants in this group will wear the Lumoback during day time for 6 weeks.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Those who will be diagnosed as non-specific low back pain by a medical doctor
Those who are using an smart phone
Symptom duration for one month or more

Key exclusion criteria

Those with history of back or lower quadrant surgery or trauma within the past 6 months
Those with history of trauma within the past 6 months
Those with history of nerve root block
within the past 4 weeks
Those with history of neuropathic
pathology such as diabetes or polyneuropathies
Those with history of vascular disease in the lower extremities
Those with systemic disease
Those with inflammatory arthropathies
Those with contraindications to manual therapy techniques such as fracture, infection or severe osteoporosis
Those who cannot communicate well for some reasons
Those without symptoms reduction or centralization by loading in the direction of lumbar extension

Target sample size

20


Research contact person

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


Public contact

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


Sponsor or person

Institute

Saitama Prefectural University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the promotion of science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


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

青木中央クリニック(埼玉県)


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 01 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

Completed

Date of protocol fixation

2015 Year 05 Month 20 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 11 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

2015 Year 07 Month 22 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=R000021285


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name