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IRCT20240306061197N3 IRCT 2026-07-23 Bagheiat-allah University of Medical Sciences The effect of a complementary medicine-based self-care bundle on symptoms of diabetic peripheral neuropathy: a randomized controlled trial The effect of a complementary medicine-based self-care bundle on symptoms of diabetic peripheral neuropathy: a randomized controlled trial 2026-07-18 anticipated 60 Complete https://irct.ir/trial/91542 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. N/A Diabetic Neuropathy. Intervention 1: 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. Intervention 2: Control group: No specific intervention is performed in the control group, and patients will continue with their previously prescribed treatments and care. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its release schedule is not yet clear.
public Amirhossein Nasirmoghadas
Mollasadra St, Vanak Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435915371 +98 21 81261 amir.h.nasirmoghadas@sbmu.ac.ir Bagheiat-allah University of Medical Sciences scientific Amirhossein Nasirmoghadas
Mollasadra St, Vanak Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435915371 +98 21 81261 amir.h.nasirmoghadas@sbmu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) 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 20 years no limit Both 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 E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified Other Other 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. Control group: No specific intervention is performed in the control group, and patients will continue with their previously prescribed treatments and care. 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. 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. 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. Bagheiat-allah University of Medical Sciences Approved 2026-06-29 Research Ethics Committees of Baqiyatallah Hospital Mollasadra St, Vanak Sq ,Tehran, Iran Tehran Tehran Iran (Islamic Republic of)