UMIN-CTR Clinical Trial

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

Chronic lower back pain

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Roland Morris Disability Questionnaire

Key secondary outcomes

Oswestry Disability Index, Visual Analogue Scale, McGill Pain Questionnaire, SF8

Study type

Interventional

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

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

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

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

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

Institute

St Luke's International Hospital

Institute

Department

Personal name

Organization

St Luke's Life Science Institute

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

04

Month

16

Day

URL releasing protocol

N/A

Publication of results

Published

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

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 related information

Registered date

2015

Year

04

Month

16

Day

Last modified on

2019

Year

10

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019887