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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017146
Receipt No. R000019887
Scientific Title Efficacy of Shiatsu for lower back pain: A Randomized Controlled Study
Date of disclosure of the study information 2015/04/16
Last modified on 2019/10/21

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Basic information
Public title Efficacy of Shiatsu for lower back pain: A Randomized Controlled Study
Acronym Shiatsu for lower back pain study
Scientific Title Efficacy of Shiatsu for lower back pain: A Randomized Controlled Study
Scientific Title:Acronym Shiatsu for lower back pain study
Region
Japan

Condition
Condition Chronic lower back pain
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of Shiatsu for chronic lower back pain
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Roland Morris Disability Questionnaire
Key secondary outcomes Oswestry Disability Index, Visual Analogue Scale, McGill Pain Questionnaire, SF8

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Shiatsu
Interventions/Control_2 Standard therapy
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
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Ambulatory patients with lower back pain.
patients with Roland Morris Disability Questionnaire of 4 or more.
60 or older patients with MMSE of 24 or more.
Patients who agree not to take any treatment, including CAM in other facilities during study period.
Ambulatory patients who can come to clinic.
Key exclusion criteria Patients with organic disease.
Dimentia patients or those with MMSE less than 24.
Patients who have severe dieases.
Those who took CAM, physical therapy or injection therapy in past year.
Patients with mental retardation or psychotic diseases.
Patients whom investigators consider unfit for this study.
Target sample size 170

Research contact person
Name of lead principal investigator
1st name Daiki
Middle name
Last name Kobayashi
Organization St Luke's International Hospital
Division name General Internal Medicine
Zip code 1048560
Address 9-1, Akashi-cho, Chuo-ku, Tokyo
TEL 03-3541-5151
Email daikoba@luke.ac.jp

Public contact
Name of contact person
1st name Daiki
Middle name
Last name Kobayashi
Organization St Luke's International Hospital
Division name General Internal Meidicine
Zip code 1048560
Address 9-1, Akashi-cho, Chuo-ku, Tokyo
TEL 03-3541-5151
Homepage URL
Email daikoba@luke.ac.jp

Sponsor
Institute St Luke's International Hospital
Institute
Department

Funding Source
Organization St Luke's Life Science Institute
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization St Luke's ethical committee
Address 9-1, Akashi-cho, Chuo-ku, Tokyo, Japan
Tel 81-3-3541-5151
Email kenkyukikaku@luke.ac.jp

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

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 16 Day

Related information
URL releasing protocol N/A
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/31331579
Number of participants that the trial has enrolled 59
Results
In our limited sample trail, Shiatsu therapy combined with standard care for lower back pain improves some symptoms and QOL shortly after Shiatsu therapy.
Results date posted
2019 Year 10 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with lower back pain for more than 12 weeks and a score of four or more on the Roland-Morris Disability Questionnaire (RMDQ) at baseline were included in this study. We excluded patients with severe conditions, such as bone metastasis, or dementia. 
Participant flow
Patients were randomly allocated to either Shiatsu therapy in addition to standard care or standard care only by computer randomization. Those allocated to Shiatsu received one-hour Shiatsu every week for four weeks. 
Adverse events
Minor adverse events, such as muscle pain.
Outcome measures
Our primary outcome was improvement of RMDQ, and secondary outcomes were improvement of Short-Form McGill Pain Questionnaire (SF-MPQ), Oswestry Disability Index (ODI) and EQ-5D after 4 weeks and 8 weeks. Bivariate analyses were applied for assessing statistical significance.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 04 Month 16 Day
Date of IRB
2015 Year 03 Month 25 Day
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 04 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 16 Day
Last modified on
2019 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019887

Research Plan
Registered date File name
2019/10/21 Shiatsu Ver2.2 2015.5.24.doc

Research case data specifications
Registered date File name
2019/10/21 説明同意文書Ver2.0.doc

Research case data
Registered date File name
2019/10/21 説明同意文書Ver2.0.doc


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