Determining the effect of ear acupressure on the symptoms of neuropathy and quality of life in patients with type 2 diabetes
Design
Clinical trial with control group, with parallel groups, single blind, randomized on 70 patients
Settings and conduct
This study is a randomized clinical trial and patients are divided into intervention and control groups based on permutation blocks. The sample size in each group is 35, the research site will be the special clinic of Shafa Hospital in Boshrouyeh. For the intervention group, ear acupressure will be performed three times a day for six weeks. In the control group, acupressure will be performed in the false point for six weeks, while patients will be unaware of being in the control or test group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient willingness and informed written consent to participate in the study;
Awareness and ability to speak and communicate;
Age between 18 and 60 years;
Get a minimum score of 6 on the Toronto Diabetic Neuropathy Questionnaire.
Non-inclusion criteria:
Taking drugs or taking strong painkillers while studying; history of disease or condition affecting neuropathy
Intervention groups
Intervention group: pressure will be applied to labels containing 5 plant seeds located in the adaptive area of the legs in the outer ear for 1 minute, 3 times a day will be done by the patient himself for 6 weeks after training.
Control group: pressure is applied to the labels containing 5 plant seeds located in the adaptive area of the heart in the outer ear for 1 minute, which is applied 3 times a day for 6 weeks by the patient himself after training
Main outcome variables
Symptoms of neuropathy, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220413054530N1
Registration date:2022-05-02, 1401/02/12
Registration timing:prospective
Last update:2022-05-02, 1401/02/12
Update count:0
Registration date
2022-05-02, 1401/02/12
Registrant information
Name
Ali Mohammadalinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3276 3578
Email address
a.mohammadnia69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-10, 1401/02/20
Expected recruitment end date
2022-07-11, 1401/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ear acupressure in comparison with sham control on neuropathy symptoms and quality of life in patients with type 2 diabetes
Public title
The effect of ear acupressure on diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient willingness and having written informed consent to participate in the study
Get a minimum score of 6 on the Toronto Diabetic Neuropathy Questionnaire
Awareness and ability to speak and communicate to report the severity of clinical symptoms during the examination
Age between 18 to 60 years
Having a natural earlobe
Exclusion criteria:
History of disease or condition affecting neuropathy based on medical history and patient report
The presence of any known complication and other medical problem leads to pain
Existence of a lesion or skin problem in the area of the ear and the site of acupressure
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients with diabetes referred to a special clinic in Boshrouyeh, affiliated to Birjand University of Medical Sciences, will be selected by an accessible and purposeful method based on inclusion criteria and then randomly divided into four groups of intervention and control by blocks of size 4. In this way, a list of 6 expected blocks (AABB, ABAB, BABA, ABBA, BAAB, BBAA) has been prepared and by assigning a number to each block (from 1 to 6) by throwing the dice, the blocks are randomly selected and the necessary allocation is made. This process will continue until the sample size is completed. (A for the experimental group and B for the control group)
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants will be randomly assigned to one of two control or test groups and will be unaware of which group they are in. For blinding in the control group, ear acupressure labels similar to the experimental group will be used, with the difference that in the control group, these labels will be used in places that will not have an effect on improving patients' neuropathy.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Asian Roadside, Gonabad - Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2022-04-11, 1401/01/22
Ethics committee reference number
IR.GMU.REC.1401.002
Health conditions studied
1
Description of health condition studied
Diabetic neuropathy
ICD-10 code
G99.0
ICD-10 code description
Autonomic neuropathy in diseases classified elsewhere
Primary outcomes
1
Description
Symptoms of neuropathy include pain and sensory disturbances (including burning, numbness, tingling, weakness, muscle cramps)
Timepoint
Beginning of the study (before the intervention) and after the intervention (six weeks after the intervention)
Method of measurement
Neuropathy Symptom Score
Secondary outcomes
1
Description
quality of life
Timepoint
At the beginning of the study (before the intervention) and six weeks after the start of the study
Method of measurement
Neuropathy specific quality of life
Intervention groups
1
Description
Intervention group: For patients in this group, in addition to the patient's routine medical care for acupressure, pressure is applied to the labels containing 5 plant seeds (which are used to form labels and the type of plant used has no effect on acupressure) located in the adaptive area of the legs in the ear. The external will be used for 1 minute (the pressure will be to the extent that the patient feels it but does not cause pain and discomfort) 3 times a day (every 8 hours) for 6 weeks by the patient after training.
Category
Other
2
Description
Control group: In this group, in addition to the patient's routine medical care, pressure is applied to the labels containing 5 plant seeds located in the adaptive area of the heart (which has no effect on patients' neuropathy) in the outer ear for 1 minute, which is 3 times. It is performed around the clock (every 8 hours) for 6 weeks by the patient himself after training.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Special clinic of Shafa Hospital
Full name of responsible person
Ali Mohammd Ali nia
Street address
Shafa Hospital; Jihad Blvd; Boshrouyeh
City
Boshrouyeh
Province
South Khorasan
Postal code
9781683641
Phone
+98 56 3120 4733
Email
a.mohammadnia69@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Leila Sadegh Moghadam
Street address
Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Asian Roadside, Gonabad- Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5723 6828
Email
ls_moghadam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?