UMIN-CTR Clinical Trial

Public title

The effects of Anma (traditional Japanese massage) -randomized trial

Acronym

The effects of Anma (traditional Japanese massage) -randomized trial

Scientific Title

The effects of Anma (traditional Japanese massage) -randomized trial

Scientific Title:Acronym

The effects of Anma (traditional Japanese massage) -randomized trial

Region

Japan

Condition

"Katakori"

Classification by specialty

Orthopedics	Rehabilitation medicine	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In this study we studied the effects of Anma therapy for "Katakori" with visual analog scale (VAS) and muscle blood volume (MBV) by near infrared spectroscopy (NIRS).
In Study 1, we tested the hypothesis that Anma treatment would reduce the "Katakori" symptom.
In Study 2, we tested the hypothesis that Anma treatment would increase muscle blood volume (MBV) in the shoulder region.
In Study 3, we tested the hypothesis that Anma treatment would reduce the "Katakori" symptom while increasing MBV in the shoulder region.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Visual analog scale (VAS)
In study 1, the VAS values of VAS paper (up to 100 mm) separated before and after Amma treatment were used to draw a vertical line before and after Amma treatment to record the "Katakori" condition. The VAS values were compared before and after Anma treatment.
In study 3, both the Anma group and the control group were (1) 7 days before Anma (Before 7), (2) immediately before Anma (Before), (3) 7th day after Anma (After 7), (4) Anma after the completion of the implementation (After 14) and the seventh day after the completion of (5) Anma (After 21), a total of 5 measurements were performed. As above mentioned, VAS values were measured before Amma treatment, and after resting for 10 minutes in the supine position, MBV was measured for 1 minute and sampled for 5 seconds for analysis.

Key secondary outcomes

Near infrared spectroscopy (NIRS)
In study 2, in the Anma group, 1 minute before the Anma treatment (Pre), immediately after the end of Anma treatment (Post 0), 1 minute later (Post 1), 2 minutes later (Post 2), 3 minutes later (Post 3), 4 minutes later (Post 4), 5 minutes later (Post 5), 6 minutes later (Post 6), 7 minutes later (Post 7), 8 minutes later (Post 8), 9 minutes later (Post 9) , we measured MBV.
In study 3, both the Anma group and the control group were (1) 7 days before Anma (Before 7), (2) immediately before Anma (Before), (3) 7th day after Anma (After 7), (4) Anma after the completion of the implementation (After 14) and the seventh day after the completion of (5) Anma (After 21), a total of 5 measurements were performed. As above mentioned, VAS values were measured before Amma treatment, and after resting for 10 minutes in the supine position, MBV was measured for 1 minute and sampled for 5 seconds for analysis.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Anma (Anma group)
In study 1, the VAS values of VAS paper (up to 100 mm) separated before and after Amma treatment were used to draw a vertical line before and after Amma treatment to record the "Katakori" condition. The VAS values were compared before and after Anma treatment.
In study 2, in the Anma group, 1 minute before the Anma treatment (Pre), immediately after the end of Anma treatment (Post 0), 1 minute later (Post 1), 2 minutes later (Post 2), 3 minutes later (Post 3), 4 minutes later (Post 4), 5 minutes later (Post 5), 6 minutes later (Post 6), 7 minutes later (Post 7), 8 minutes later (Post 8), 9 minutes later (Post 9), we measured MBV.
We measured MBV 1 minute before the Anma treatment and 10 minutes after the Anma treatment, and was analyzed by sampling for 5 seconds at each 1 minute interval.
In study 3, both the Anma group and the control group were (1) 7 days before Anma (Before 7), (2) immediately before Anma (Before), (3) 7th day after Anma (After 7), (4) Anma after the completion of the implementation (After 14) and the seventh day after the completion of (5) Anma (After 21), a total of 5 measurements were performed. As above mentioned, VAS values were measured before Amma treatment, and after resting for 10 minutes in the supine position, MBV was measured for 1 minute and sampled for 5 seconds for analysis. The total number of treatments was 4 (2 times / week).
As illustrated the Anma group had Anma therapy; the body position was in the lateral decubitus position (left to right), and the treatment site was performed in the order of (1) cervical portion (2) upper shoulder region (3) upper limb (4) interscapular region (5) dorsal region (6) lumbar region (7) gluteal region (8) lower limb.
The procedure was illustrated as below; stroking, kneading, pushing, tapping, Kyokude (a specific Japanese technique), and stroking were performed in this order for 45 minutes.

Interventions/Control_2

No Anma (control group)
In the control group, only the measurement was performed using the same schedule as that of the Anma group. In the control group, the participants were lying down for 45 minutes.

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1)Adults aged 20-80
(2)Those who are aware of "Katakori"
(3)Those who can participate in the research schedule

Key exclusion criteria

(1)No muscle or bone disease (cervical arm syndrome, frozen shoulder, low back pain osteoarthritis, etc.)
(2)No gastrointestinal disorders (gastritis, gastric/duodenal ulcer, etc.)
(3)No cardiovascular disease (angina, etc.)/respiratory disease (bronchial asthma, bronchitis, etc.)
(4)Diabetes
(5)Malignant tumor
(6)Those who are pregnant or breastfeeding
(7)No history of contact dermatitis due to an adhesive tape.

Target sample size

228

Name of lead principal investigator

1st name	hidetoshi
Middle name
Last name	mori

Organization

National University Corporation Tsukuba University of Technology

Division name

Department of Health, Faculty of Health Science

Zip code

305-8521

Address

4-12-7 Kasuga, Tsukuba City, Ibaraki Prefecture, 305-8521, Japan

TEL

+81-29-856-3570

Email

h.mori.tsukuba@gmail.com

Name of contact person

1st name	hiroshi
Middle name
Last name	kuge

Organization

Osaka Medical College Hospital

Division name

Department of Anesthesiology Pain Clinic

Zip code

569-8686

Address

2-7 Daigaku-machi, Takatsuki City, Osaka Prefecture, 569-8686, Japan

TEL

+81-90-1487-1151

Homepage URL

Email

sherry@kha.biglobe.ne.jp

Institute

National University Corporation Tsukuba University of Technology

Institute

Department

Personal name

Organization

National University Corporation Tsukuba University of Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Osaka Medical College Hospital

Address

2-7 Daigaku-machi, Takatsuki City, Osaka Prefecture, 569-8686, Japan

Tel

+81-90-1487-1151

Email

sherry@kha.biglobe.ne.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立大学法人 筑波技術大学(茨城県)

Date of disclosure of the study information

2020

Year

07

Month

13

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/fileshare/registrant.cgi

Publication of results

Unpublished

URL related to results and publications

https://upload.umin.ac.jp/cgi-bin/fileshare/registrant.cgi

Number of participants that the trial has enrolled

110

Results

Anma for Katakori stiff shoulders was found to relieve the symptoms of Katakori stiff shoulders and have an immediate effect on increasing muscle blood volume (MBV).

Results date posted

2020

Year

07

Month

09

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The subjects of this study are 110 (26 men, 84 women), average age 51.6 (10.6)
years (27-75 years).
As a result of the recruitment, the subjects of Study 1 were 77 men and women who complained of "Katakori", and the grouping was performed by a third party using a computer to generate random numbers, and a group with Anm (Anma group) and a group without Anma (control group). Anma group has 37 people (12 men, 25 women), average age 48.9 (11.5) years (27-75 years), control group 40 people (8 men, 32 women), average age 51.0 (10.2) years (28-75 years old). Anma group has 37 people (12 men, 25 women), average age 48.9 (11.5) years (27-75 years), control group 40 people (8 men, 32 women), average age 51.0 (10.2) years (28-75 years old).
The subjects of study 2 were 13 men and women who complain of "Katakori" (3 men and 10 women) and ages 40 to 71 years (average age 56.5 (9.0) years).The grouping was performed by randomizing a third person using a computer to perform the Anma treatment (group A) and not perform the Anma treatment (group B). Seven of 13 subjects were subjected to Anma treatment (group A), and 6 were not subjected to Anma treatment (group B). Then, 7 persons who performed in group A were reversed from group B, and 6 persons in group B performed according to the schedule of group A (crossover method).
In the study 3, total number of subjects were 20, who complained of "Katakori", and were divided into two groups by the envelope method: a group with an Anma (Anma group) and a group without an Anma (control group). The envelope method was performed using two types of cards (Anma group and control group).Anma group is 10 people (2 men, 8 women), age 40-71 years (average age 53.4 (9.3) years), the control group 10 people (1 man, 9 women), age 45-68 years (average age 56.0 (7.2) years).

Participant flow

The numbers randomly assigned, the numbers used for outcome analysis, and the numbers used for statistical analysis were the same as those at the start of the study.

Adverse events

There were no unintended effects (adverse events).

Outcome measures

Study 1: Level of pain or discomfort in the "Katakori" was assessed using a visual analog scale (VAS).
Study 2: Muscle blood volume (MBV) in the shoulder region was assessed using near-infrared spectroscopy (NIRS).
Study 3: Level of pain or discomfort in the "Katakori" was assessed using a VAS. As well, MBV in the shoulder region was assessed using NIRS.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

08

Month

01

Day

Date of IRB

2014

Year

10

Month

02

Day

Anticipated trial start date

2014

Year

11

Month

04

Day

Last follow-up date

2015

Year

10

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

07

Month

12

Day

Last modified on

2020

Year

07

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046850