The effect of acupressure in the Zusanli point (ST36) on fasting blood glucose and glycosylated hemoglobin among type II diabetic patients.
Design
The sample size in this clinical trial is 102 patients. Patients are divided into parallel groups of intervention, placebo, and control using a triangular permutation block sampling method.
Settings and conduct
This study is done at Shahid Motahari Clinic affiliated to Shiraz University of Medical Sciences. In this study, among the referrals to this clinic, 102 people who have the criteria for entering the study are selected. after getting conscious written consent and completing the demographic form, blood samples will be taken from the patients for testing blood glucose and glycosylated hemoglobin. The intervention group and the placebo receive acupressure at the zusanli and false points inturn, But the control group does not receive intervention. Immediately at the end of the intervention,
glycosylated hemoglobin and fasting blood glucose will be checked for three groups and the results are compared with each other.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with type 2 diabetes based on the diagnosis of an Internist; passing at least 3 years from the onset of diabetes; Patients older than 18 years; willingness to be involved in research; One of the family members accompanies the patient. Exclusion criteria: Foot vascular disease; Skin wounds and fracture in the target area (Zusanli); Known skeletal muscle disease in the target area (Zusanli).
Intervention groups
In this study, intervention group receives acupressure in the Zusanli point and placebo group receives acupressure on sham point. The control group receives only standard treatments.
Main outcome variables
glycosylated hemoglobin and fasting blood glucose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111224008505N47
Registration date:2018-06-24, 1397/04/03
Registration timing:retrospective
Last update:2018-06-24, 1397/04/03
Update count:0
Registration date
2018-06-24, 1397/04/03
Registrant information
Name
Seyed Saeed Najafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1727 7445
Email address
najafisa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of zusanli Point (ST36) Acupressure on Fasting blood sugar and glycosylated hemoglobin in type II diabetic patients
Public title
The effect of acupressure on fasting blood glucose and glycosylated hemoglobin
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes based on the diagnosis of an Internist
Passing at least 3 years from the onset of diabetes
Patients older than 18 years
Patients tend to be involved in research
One person in the family should be with the patient through the study
Exclusion criteria:
Foot vascular disease
Skin wounds and fractures in the target area (Zusanli)
Known skeletal muscle disease in the target area (Zusanli)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study is done using the Permutation block method. The block of size 3 (A, B and C) will be used in this study. A, B and C represent the people who are placed in the experimental, placebo and control groups, respectively. Allocated to the experimental, placebo & control groups will be done using random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants are unaware of which group they are allocated to.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2018-02-25, 1396/12/06
Ethics committee reference number
IR.SUMS.REC.1396.183
Health conditions studied
1
Description of health condition studied
Diabetes mellitus type 2
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
glycosylated hemoglobin
Timepoint
Pre intervention, post intervention
Method of measurement
Blood test with Pars Azmun Kit
2
Description
Fasting blood sugar
Timepoint
Pre intervention, post intervention
Method of measurement
Blood test Pars Azmun Kit
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: In addition to receive standard treatments, the pressure in the Zusanli point (4 fingers below the knee) will be applied at 3-5 kilograms intensity. The pressure will be applied as one pressure per second until 5 seconds and then the patient rests for 2 seconds. This process will be repeated for 3 minutes. The intervention will be performed through three 6-minute sessions (3 minutes for left foot and 3 minutes for right foot) in the week during 12 weeks.
Category
Prevention
2
Description
The second intervention group(placebo): In addition to receive standard treatments, the pressure in the sham point (6 fingers below the knee) will be applied at 3-5 kilograms intensity. The pressure will be applied as one pressure per second until 5 seconds and then the patient rests for 2 seconds. This process will be repeated for 3 minutes. The intervention will be performed through three 6-minute sessions (3 minutes for left foot and 3 minutes for right foot) in the week during 12 weeks.