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Effectiveness of Foot Bathing, Massage, and Range of Motion Exercise on Diabetic Patients' Peripheral Neuropathy: A Randomized Controlled Trial

Protocol summary

Study aim
To compare the effectiveness of foot bathing, foot massage, and range-of-motion exercises on diabetic patients' peripheral neuropathy
Design
An experimental comparative design with a minimum sample size of 25 for each group will be used. The total sample size would be 100 subjects, followed for 2 weeks.
Settings and conduct
The study was conducted in the Al-Hassan specialization Center for Endocrinology and Diabetes in Karbala, Iraq
Participants/Inclusion and exclusion criteria
All adult patients (over 18) who have been diagnosed with diabetes for more than 10 years and admitted to diabetes centers will be included in the study. Patients with 5 or less in Toronto Clinical Neuropathy Score, foot gangrene, an amputated right or left foot, or paralysis Patients with any disease or condition that causes neuropathy and interferes with study results will be excluded
Intervention groups
Data will be collected using a pre-test and post-test method. After assessing the level of diabetic peripheral neuropathy based on the Toronto Clinical Neuropathy Score (TCNS), the samples will be allocated into four groups, including a group that applied foot massage for 25 minutes per session, a group that applied bathing to the foot for 15 minutes, a group that applied range-of-motion exercises for the feet for 30 minutes per session, and a control group that did not receive any intervention. Each participant in the intervention group attends three sessions per week for two weeks. Then patients in all groups were evaluated prior to the intervention (post-test assessment) after two weeks by using TCNS
Main outcome variables
Reducing DPN level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221220056877N1
Registration date: 2022-12-25, 1401/10/04
Registration timing: prospective

Last update: 2022-12-25, 1401/10/04
Update count: 0
Registration date
2022-12-25, 1401/10/04
Registrant information
Name
Taher Alfaham
Name of organization / entity
Kerbala University/College of Nursing
Country
Iraq
Phone
+964 783 906 5883
Email address
taher.m@uokerbala.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-10, 1401/10/20
Expected recruitment end date
2023-03-01, 1401/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Foot Bathing, Massage, and Range of Motion Exercise on Diabetic Patients' Peripheral Neuropathy: A Randomized Controlled Trial
Public title
Effectiveness of Foot Bathing, Massage, and Range of Motion Exercise on patients with Diabetic Peripheral Neuropathy: A Clinical Trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are more than or equal to 18 years old Patients who have been diagnosed with diabetes for 10 years and more Patients who have Diabetic Peripheral Neuropathy (DPN) of more than 5 on Toronto Clinical neuropathy score (TCNS) Patients with Type-1 and Type-2 Diabetes Mellitus
Exclusion criteria:
Patients with score of 5 and less than in TCNS scale Patients who have Chemotherapy-Induced Peripheral Neuropathy Patients with foot gangrene Patients with amputated right or left foot Patients who refused to participate in the study Patients with paralysis, partly or entirely unable to move the affected parts of the body patients with osteoarthritis and osteomyelitis, rheumatoid arthritis Patient with certain viral or bacterial infections, including Lyme disease, shingles, Epstein-Barr virus, hepatitis B and C, leprosy, Diphtheria, and HIV) Patients who are receiving any physiotherapy intervention Patients with inherited disorders, such as Charcot-Marie-Tooth disease are hereditary types of neuropathy; Patients with autoimmune diseases, include lupus, Guillain-Barre syndrome, demyelinating polyneuropathy and vasculitis Patients with bone marrow disorders, These include Multiple myeloma, lymphoma and amyloidosis Patients with other diseases, include kidney and liver disease, connective tissue disorders and hypothyroidism)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
In order to maintain a transparent and scientifically based randomization process, stratified randomization will be used in assigning participants (individuals: diabetic patients with peripheral neuropathy) to intervention (foot bathing, foot massage, and range of motion exercise) and control groups, assuming that each participant has an equal chance of being assigned to any group. The simple randomization procedure would involve choosing a color from a sealed envelope that contains four numbers: blue, yellow, green, and red (blue would be in the foot bathing group, yellow would be in the foot massage group, green would be in the range of motion exercises group, and red would be in the control group). Indeed, four groups will be allocated randomly.
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 in College of Nursing at University of Baghdad
Street address
Bab-AlMuadham
City
Baghdad
Postal code
10053
Approval date
2022-12-19, 1401/09/28
Ethics committee reference number
4626

Health conditions studied

1

Description of health condition studied
Diabetes Mellitus
ICD-10 code
G90.0
ICD-10 code description
Idiopathic peripheral autonomic neuropathy

Primary outcomes

1

Description
The primary outcome variable is the level of Diabetic Peripheral Neuropathy that can be changed based on foot bathing, foot massage, and ROM exercises
Timepoint
Before intervention and two weeks after intervention
Method of measurement
The Toronto Clinical Neuropathy Score will be used to assess the level of DPN

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After assessing the level of diabetic peripheral neuropathy, the sample will be allocated into four groups: the foot bathing group, which involves immersing both patients' feet in 5 liters of tolerably warm water (between 40 and 45 °C) with 250 grams of powdered mineral salt added and dissolved; the foot massage group, in which the researcher's thumb is used to apply gentle, gradually increasing pressure along the three meridians lines on the feet. Pressure is also applied to the area of the knee in the supine and side-lying positions and to the lower leg, ankle, and foot of the participants. The range-of-motion exercise group combined ROM with plantar exercise and placed a tennis ball for 30 minutes every two days. The active ROM procedure covered flexion-extension-adduction-abduction in the hips and toes, flexion-extension of the knees, dorsiflexion and plantar flexion in the ankles, and inversion-eversion of the legs. Place a tennis ball on the ground and ask patients to gently roll it underfoot, backward and forward, and rotate it along the plantar for five minutes to relax the muscles in the plantar fascia. Then patients in all groups were evaluated prior to the intervention (post-test assessment) after two weeks by using the Toronto Clinical Neuropathy Score.
Category
Treatment - Other

2

Description
Control group: The control group received no interventions; instead, they received pre-test and post-test assessments after two weeks, as did the other groups, and they will be compared to the other groups in the study. Then patients in all groups were evaluated prior to the intervention (post-test assessment) after two weeks by using the TCNS.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Hassan specialization Center for Endocrinology and Diabetes
Full name of responsible person
Karbala Health Directorate
Street address
Al-Baladia district street
City
Karbala
Postal code
56001
Phone
+964 783 906 5883
Email
Taher.m@uokerbala.edu.iq

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Baghdad
Full name of responsible person
Taher Mohsin Hashim Al-Fahham
Street address
Al-Baladia District
City
Karbala
Postal code
56001
Phone
+964 783 906 5883
Email
nursing.college.uob@gmail.com
Web page address
http://conursing.uobaghdad.edu.iq/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source
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
University of Kerbala
Full name of responsible person
Taher Mohsin Hashim Al-Fahham
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Al-Baladia district
City
Karbala
Province
Karbala
Postal code
56001
Phone
+964 783 906 5883
Email
taher.m@uokerbala.edu.iq
Web page address
https://nursing.uokerbala.edu.iq/wp/en/

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Kerbala
Full name of responsible person
Taher Mohsin Hashim Al-Fahham
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Al-Baladia distric
City
Karbala
Province
Karbala
Postal code
56001
Phone
+964 783 906 5883
Email
taher.m@uokerbala.edu.iq
Web page address
https://nursing.uokerbala.edu.iq/wp/en/

Person responsible for updating data

Contact
Name of organization / entity
University of Kerbala
Full name of responsible person
Taher Mohsin Hashim Al-Fahham
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Al-Baladia District
City
Karbala
Province
Karbala
Postal code
56001
Phone
+964 783 906 5883
Email
taher.m@uokerbala.edu.iq
Web page address
https://nursing.uokerbala.edu.iq/wp/en/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The data will be the results of the TCNS that measure patients' DPN levels in both the control and intervention groups.
When the data will become available and for how long
God Willing, once the article is published, the data will be available after 6 months of publication. If the article will be published in a subscribed journal, the data will be available after one year because of the policy of the subscribed journals.
To whom data/document is available
with academic nurses and any researcher who is interested in the data.
Under which criteria data/document could be used
The data could be used after getting permission via email. Also, users need to acknowledge the owner.
From where data/document is obtainable
Users can ask for the data and permission via email. Taher Al-Fahham is the corresponding author. He will contact whoever he requests the information from. His email is taher.m@uokerbala.edu.iq Taher Al-Fahham works at the University of Kerbala/College of Nursing. The address is Al-Muadhafeen district, Karbala, Iraq. What processes are involved for a request to access data/document
What processes are involved for a request to access data/document
Users can ask for the data and permission via email. Taher Al-Fahham is the corresponding author. He will contact whoever he requests the information from. His email is taher.m@uokerbala.edu.iq
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