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The effect of a complementary medicine-based self-care bundle on symptoms of diabetic peripheral neuropathy: a randomized controlled trial

Protocol summary

Study aim
Determining the effect of a complementary medicine-based self-care bundle on diabetic neuropathy symptoms
Design
An unblinded, randomized, parallel-group (intervention and control) trial involving 60 diabetic neuropathy patients.
Settings and conduct
Diabetes Clinic, Baqiyatallah Hospital, Tehran, Iran
Participants/Inclusion and exclusion criteria
This study will enroll male and female patients aged at least 20 years with type 1 or type 2 diabetes who have at least mild diabetic neuropathy. Conversely, patients with other types of neuropathy, active diabetic foot ulcers, or an inability to perform diabetic foot self-care will be excluded.
Intervention groups
Patients in the intervention group will receive face-to-face training on a complementary medicine-based self-care package; this includes foot massage, acupressure (on ST36, SP6, LR3, BL60, and KI3 acupoints), and daily diabetic foot care (such as maintaining foot hygiene, daily skin inspection, and selecting appropriate footwear and socks). Additionally, these patients will receive two short instructional videos and two educational pamphlets, the contents of which have already been validated by ten experts in the field, including faculty members in nursing, traditional medicine, endocrinology/diabetes, and wound care. The intervention will be performed daily for 2 months. Each session will consist of a 10-minute foot massage (from the ankle down), acupressure on both feet (two minutes for each acupoint), and daily diabetic foot care. No specific intervention will be administered to the control group. Study outcomes will be assessed for all patients before and after the intervention period.
Main outcome variables
Severity of peripheral neuropathy (0-10) based on the United Kingdom Screening Test; Severity of neuropathic pain (0-10) based on the Visual Analogue Scale; Health-related quality of life based on the SF-12 questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240306061197N3
Registration date: 2026-07-23, 1405/05/01
Registration timing: registered_while_recruiting

Last update: 2026-07-23, 1405/05/01
Update count: 0
Registration date
2026-07-23, 1405/05/01
Registrant information
Name
Amirhossein Nasirmoghadas
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8803 8972
Email address
amir.h.nasirmoghadas@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-07-18, 1405/04/27
Expected recruitment end date
2026-08-22, 1405/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a complementary medicine-based self-care bundle on symptoms of diabetic peripheral neuropathy: a randomized controlled trial
Public title
The effect of a complementary medicine-based self-care bundle on symptoms of diabetic peripheral neuropathy: a randomized controlled trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 1 or 2 diabetes Ability to perform diabetic foot self-care Presence of at least mild neuropathy based on the Michigan Neuropathy Screening Instrument (total score > 2) Over 20 years old
Exclusion criteria:
Absence of neuropathy caused by other conditions such as chronic alcohol use; peripheral nerve damage (e.g., due to injury or surgery); chronic liver or kidney disease; uncontrolled hypothyroidism; history of cancer or chemotherapy; HIV/immunodeficiency; multiple sclerosis (MS), Guillain-Barré syndrome, ALS, Parkinson's disease, stroke, spinal cord injury, gout, or deep vein thrombosis (DVT). Absence of active diabetic foot ulcers or any injuries, wounds, or skin lesions on the feet. Abcence of movement disabilities in the limbs
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, subject to informed consent, each participant is assigned to either the intervention or the control group via a coin toss; "heads" designates the intervention group, while "tails" designates the control group.
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
Research Ethics Committees of Baqiyatallah Hospital
Street address
Mollasadra St, Vanak Sq ,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2026-06-29, 1405/04/08
Ethics committee reference number
IR.BMSU.BAQ.REC.1405.019

Health conditions studied

1

Description of health condition studied
Diabetic Neuropathy
ICD-10 code
E08.40
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified

Primary outcomes

1

Description
Severity of peripheral neuropathy based on the United Kingdom Screening Test (UKST)
Timepoint
Before and after the intervention
Method of measurement
The United Kingdom Screening Test will be used, comprising two sections: symptoms and physical findings. Each section is scored separately, with a higher score indicating more severe neuropathy. The symptoms section consists of five questions regarding the symptoms experienced by patients, yielding a total score ranging from 0 to 9. The physical findings section assesses the Achilles tendon reflex, pinprick sensation, vibration sensation, and temperature sensation, resulting in a total score between 0 and 10.

2

Description
Severity of neuropathic pain
Timepoint
Before and after the intervention
Method of measurement
Using the Visual Analogue Scale (VAS), the patient rates the severity of neuropathic pain experienced over the past week on a scale of 0 to 10; a higher score indicates more severe pain.

3

Description
Health-related quality of life
Timepoint
Before and after the intervention
Method of measurement
Using the SF-12 questionnaire, which comprises 12 items covering both mental and physical dimensions, the total score ranges from 12 to 48, with higher scores indicating better quality of life.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in the intervention group will receive face-to-face training on a complementary medicine-based self-care package; this includes foot massage, acupressure (on ST36, SP6, LR3, BL60, and KI3 acupoints), and daily diabetic foot care (such as maintaining foot hygiene, daily skin inspection, and selecting appropriate footwear and socks). Additionally, these patients will receive two short instructional videos and two educational pamphlets, the contents of which have already been validated by ten experts in the field, including faculty members in nursing, traditional medicine, endocrinology/diabetes, and wound care. The intervention will be performed daily for 2 months. Each session will consist of a 10-minute foot massage (from the ankle down), acupressure on both feet (2 minutes per acupoint), and daily diabetic foot care. No specific intervention will be administered to the control group. Study outcomes will be assessed for all patients before and after the intervention period.
Category
Other

2

Description
Control group: No specific intervention is performed in the control group, and patients will continue with their previously prescribed treatments and care.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Saeed Hashemi
Street address
Mollasadra St, Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
hashemisaeed65@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Reza Kachuei
Street address
Mollasadra St, Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
researchcenter@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Amirhossein Nasirmoghadas
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mollasadra St, Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Fax
Email
amir.h.nasirmoghadas@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Amirhossein Nasirmoghadas
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mollasadra St, Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Fax
Email
amir.h.nasirmoghadas@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Amirhossein Nasirmoghadas
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mollasadra St, Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Fax
Email
amir.h.nasirmoghadas@sbmu.ac.ir

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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