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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018380
Receipt No. 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

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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
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 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
URL(English) https://upload.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


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