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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041076
Receipt No. R000046850
Scientific Title The effects of Anma (traditional Japanese massage) -randomized trial
Date of disclosure of the study information 2020/07/13
Last modified on 2020/07/12

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Basic information
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
Condition "Katakori"
Classification by specialty
Orthopedics Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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.

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute National University Corporation Tsukuba University of Technology
Institute
Department

Funding Source
Organization National University Corporation Tsukuba University of Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立大学法人 筑波技術大学(茨城県)

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 13 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/fileshare/registrant.cgi
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2020 Year 07 Month 12 Day
Last modified on
2020 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046850

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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