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: The Effect of Uriculotherapy on Pain, Sleep Quality, and Functional Disability in Elderly People with Chronic Low Back Pain

Protocol summary

Study aim
Determining the effect of uriculotherapy on pain, sleep quality, and functional disability in elderly people with chronic low back pain
Design
A clinical trial with two groups of control and intervention, has been randomized, without blindness. The sample size is 70,
Settings and conduct
This study was conducted at the Taleghani and Akramian comprehensive health center of Kashan. Qualified samples were randomly divided into two intervention and control groups. Uriculotherapy was performed three times a day for 4 weeks and five days a week. Which points are different in both groups.At the end of the data, descriptive and inferential statistics will be analyzed and analyzed.
Participants/Inclusion and exclusion criteria
Entry requirements: Age 60 and older, Lower back pain for at least 3 months, Health in the tulip ear,The desire to participate in the study Non-arrival conditions: Lower back pain for some reason like a back injury, Acute low back pain, Those who get information from them are difficult
Intervention groups
In the intervention group, four times a week, five days a week, three times a day, and at the same time, pain will be done; In this group, the Vacheria Marc DONG BANG cheeses made by Korea on the sites of Shengman, Sympathetic, Subcortex and Lumbar were studied by the researcher. The elderly person will be instructed to follow these aids each time for three minutes with his index finger and thumb according to the schedule. In the comparison group, the uriculotherapy with a similar protocol, but on the kidney, stomach, mouth and duodenum, which is not proven to be pain-related will be performed. It should be noted that in both groups, during the 4 weeks of intervention, the Vakaria syndrome by the researcher will be alternately fastened to both ears within a week.
Main outcome variables
Severity of pain, Sleep quality, Functional disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190303042891N1
Registration date: 2019-07-01, 1398/04/10
Registration timing: retrospective

Last update: 2019-07-01, 1398/04/10
Update count: 0
Registration date
2019-07-01, 1398/04/10
Registrant information
Name
Maryam Pourmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5474 5438
Email address
pourmohammadi-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: The Effect of Uriculotherapy on Pain, Sleep Quality, and Functional Disability in Elderly People with Chronic Low Back Pain
Public title
: The Effect of Uriculotherapy on Pain, Sleep Quality, and Functional Disability in Elderly People with Chronic Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 and above Having a back pain for at least 3 months 3) willingness to participate in the study Gain score more than 5/25 of the COST tool Iranian citizenship Get a 4 up score from the VAS tool Get a 5 up score from Pittsburgh Sleep Quality Tool Acquire the maximum 25-point rating of Oswestry functional disability tool Ability to communicate in Farsi Health in the Auricle
Exclusion criteria:
Lower back pain for some reason like a back injury Acute low back pain Those who get information from them are difficult Known mental illness based on the contents of the electronic health record Known mental retardation based on the contents of the electronic health record Autoimmune and malignant diseases is confirmed by a specialist Congenital anomalies (with the exception of mild lordosis and scoliosis), fracture or infection in the spine, confirmed by a specialist physician Use of acupuncture or needles during the last three months Surgery in the spine History of bump in the back during the past month drug and alcohol addiction Do sports in a professional manner
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks randomization in the form of blocks 4, 6 and 8 will be assigned to each of the two intervention and comparison groups. Using the Sealed Envelope Ltd. software. 2017 available through the site www.sealedenvelope.com blocks 4, 4 blocks 8 and 5 blocks 6, a total of 11 blocks were defined, which will be allocated to the groups according to the order specified by the tool.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Ghotbe ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1397.064

Health conditions studied

1

Description of health condition studied
Chronic low back pain in the elderly
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
Chronic low back pain
Timepoint
Measured at the beginning of the study, during the intervention (end of each week), the end of the intervention, and 4 weeks after the end of the intervention.
Method of measurement
The short form of the McGill Pain questionnaire and the Visual analogue tool for pain assessment

2

Description
Sleep quality
Timepoint
Measured at the beginning of the study and after the end of the intervention and 4 weeks after the end of the intervention.
Method of measurement
Pittsburgh sleep quality questionnaire

3

Description
Functional disability
Timepoint
Measured at the beginning of the study and after the end of the intervention and 4 weeks after the end of the intervention.
Method of measurement
Functional disability questionnaire Oswestry

Secondary outcomes

1

Description
Allergy to Vacheria glue
Timepoint
Daily
Method of measurement
See red, inflammation, or feeling itching in the ear by elderly

Intervention groups

1

Description
Intervention group: In the intervention group Uriculotherapy will be done at the time of pain, three times a day and five days a week during 4 weeks. In this group, the Vacheria seeds (with brand name Dong Bang made by Korea) are pasted by the researcher on the points of Shenman, Sympathetic, Subcortex and Lumbar. Participants will be taught by the researcher that seeds would be pressed with index and thumb finger for three minutes each time.
Category
Treatment - Devices

2

Description
Control group: In the Control group, Uriculotherapy will be done at the time of pain, three times a day and five days a week during 4 weeks too. In this group, the Vacheria seeds (with brand name Dong Bang made by Korea) are pasted by the researcher on the points of the stomach; kidney, mouth and duodenum that have been proven these points are not related to pain. Participants will be taught by the researcher that seeds would be pressed with index and thumb finger for three minutes each time.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive health center of Taleghani
Full name of responsible person
Tagharrobi Zahra
Street address
Taleghani street,-Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5544 3307
Fax
+98 31 5544 3308
Email
pori9830@gmail.com

2

Recruitment center
Name of recruitment center
Comprehensive health center of Golabchi
Full name of responsible person
Tagharrobi Zahra
Street address
Imam street, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5545 6465
Fax
+98 31 5545 6466
Email
pori9830@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research assistance of Kashan university of medical sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Ghotbe ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5557 8010
Email
banafsheh-h@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research assistance of Kashan university of medical sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Tagharrobi Zahra
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ghotbe ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
tagharrobi_z@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Tagharribi Zahra
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ghotbe ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
tagharrobi_z@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Maryam Pourmohammadi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghotbe ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
pori9830@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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