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Evaluation of the effect of modified foot reflexology massage on the intensity of peripheral neuropathy in the elderly with type 2 diabetes induced neuropathy

Protocol summary

Study aim
Determining the effect of modified reflexology massage on the severity of peripheral neuropathy in elderly patients with type 2 diabetes
Design
A clinical trial with a control group, with parallel groups, single blind, randomized, on 60 patients. For randomization, the software for generating random codes in the form of permutation blocks is used.
Settings and conduct
Place of study: Health centers of Quchan city; Study population: elderly with peripheral neuropathy caused by type 2 diabetes; Type of blinding: single blind; How to blind: the elderly are unaware of the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: elderly at the age of 60 years and older with diabetic neuropathy; Having a health record in health centers; Having a knowledgeable caregiver; At least one week has passed since the start of insulin treatment. Exclusion criteria: Receiving massage before starting the study; Use of mobility aids; Having orthopedic, rheumatology, vascular, nervous and mental system disorders affecting neuropathy; The presence of a wound or amputation in the leg
Intervention groups
Intervention group: After performing the preparation techniques, the caregiver massages points on the legs related to pancreas, liver, kidney and stomach. Control group: the caregiver massages the same points without pressure, to the extent of touching the skin.
Main outcome variables
Intensity of peripheral neuropathy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210612051553N1
Registration date: 2023-09-12, 1402/06/21
Registration timing: prospective

Last update: 2023-09-12, 1402/06/21
Update count: 0
Registration date
2023-09-12, 1402/06/21
Registrant information
Name
Fateme Bakzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4724 2185
Email address
fatimabakzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of modified foot reflexology massage on the intensity of peripheral neuropathy in the elderly with type 2 diabetes induced neuropathy
Public title
ٍEffect of modified foot reflexology massage on the intensity of peripheral neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being 60 years old and over Having a health record in the health center (Includes demographic information and medical records) Having diabetic neuropathy diagnosed by a physician Having a knowledgeable and trainable caregiver Passing at least one week since the start of insulin treatment
Exclusion criteria:
Having orthopedic, rheumatological, vascular disorders, disorders of the nervous and mental system affecting neuropathy (such as deep vein thrombosis, varicose veins, gout, diagnosis of stroke, multiple sclerosis, Parkinson's, spinal cord injury, and Guillen are diagnosed) based on physician's approval Having a wound and amputation in the leg Receiving any message before study initiation Being on medications effective on sympathetic system
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
First, a purposive sampling will be done; then eligible subjects will be randomly allocated into two groups, using permutation blocks randomization approach and the codes generated by the relevant software. Subjects will be randomized individually.
Blinding (investigator's opinion)
Single blinded
Blinding description
After selecting and entering the eligible elderly to study, they will be informed that they will receive one of the two types of massage in this study. But the elderly will not be informed about how people are placed in the groups until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
Central Building of North Khorasan University of Medical Sciences, Dolat Blvd, Bojnurd
City
Bojnurd
Province
North Khorasan
Postal code
9414974877
Approval date
2022-01-10, 1400/10/20
Ethics committee reference number
IR.NKUMS.REC.1400.157

Health conditions studied

1

Description of health condition studied
Peripheral neuropathy in the elderly with type 2 diabetes
ICD-10 code
E11.4
ICD-10 code description
Type 2 diabetes mellitus with neurological complications

Primary outcomes

1

Description
Intensity of peripheral neuropathy based on the Michigan instrument
Timepoint
Study onset (day 0) , days 10, 20, 30 and 40 (Ten days after the end of the intervention).
Method of measurement
Michigan Instrument

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The members of the intervention group will be trained in modified foot reflexology massage in such a way that the caregiver, after performing the preparation techniques, massages the points in the legs related to the pancreas, liver, kidney and stomach. The intervention protocol is 10 minutes each time (for each leg, which includes 2 minutes of preparation and 8 minutes of massaging the defined points) during the first 30 days.
Category
Treatment - Other

2

Description
Control group: The members of the control group are given false foot massage training in such a way that the caregiver, after performing the preparation techniques, massages the points on the legs related to the pancreas, liver, kidneys and stomach by touching the skin of the feet without pressure. The intervention protocol, during the first 30 days, is 10 minutes each time (for each leg, which includes 2 minutes of preparation and 8 minutes of massaging the defined points).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Quchan urban health centers
Full name of responsible person
Farshid Fathi
Street address
Imam St., Shahid Rahwareh
City
Quchan
Province
Razavi Khorasan
Postal code
9471954643
Phone
+98 51 4722 4060
Email
fathirf1@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr. Ali Esmaili
Street address
Central Building of North Khorasan University of Medical Science, Dolat Blvd
City
Bojnurd
Province
North Khorasan
Postal code
9417696786
Phone
+98 58 3151 1206
Fax
Email
research@nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Fatemeh Bakzadeh
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bojnurd School of Nursing and Midwifery, Shahriar St.
City
Bojnurd
Province
North Khorasan
Postal code
9414974877
Phone
+98 58 4724 2185
Email
fatimabakzadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Armat
Position
Academic member - Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Bojnurd School of Nursing and Midwifery, Shahriar St.
City
Bojnurd
Province
North Khorasan
Postal code
9414974877
Phone
+98 58 3229 7097
Email
armat@nkums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Fatemeh Bakzadeh
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bojnurd School of Nursing and Midwifery, Shahriar St.
City
Bojnurd
Province
North Khorasan
Postal code
9417696786
Phone
+98 58 3222 1910
Email
fatimabakzadeh@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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