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The effect of evening primrose with the help of ultrasound waves on neuropathy symptoms of type 2 diabetes

Studying the effectiveness of evening primrose with the help of ultrasonic waves on the symptoms of peripheral neuropathy in people with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200125046249N1
Enrollment
39
Registered
2024-04-30
Start date
2024-07-05
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes. Diabetes mellitus with polyneuropathy

Interventions

Intervention 1: Intervention group: Using plug in ultrasound along with an ineffective ointment. Intervention 2: Intervention group: Using plug in ultrasound along with Linoderm ointment. Intervention

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes between 45-75 years of age and with symptoms of neuropathy in the lower limbs diagnosed by NCV.

Exclusion criteria

Exclusion criteria: The presence of neuropathy symptoms without the presence of diabetes Infectious diabetic ulcers Systemic peripheral vascular problems The presence of chronic diseases such as coronary artery disease Chronic lung diseases kidney problems History of drug allergy pregnancy Reluctance to cooperate

Design outcomes

Primary

MeasureTime frame
Pain with Numeric Pain Rating Scale(NRS):It is a chart to determine the intensity of the patient's pain before and after the study. The chart is numbered from zero, meaning no pain, to 10, meaning severe pain. Timepoint: pain measurement at the beginning of the study (before the start of the intervention) and immediately after the completion of 6 treatment sessions (after two weeks from the start of the treatment) and one month after the treatment. Method of measurement: Numeric Pain Rating Scale.

Secondary

MeasureTime frame
Conduction speed of sensory, motor and mixed nerves of tibial and peroneal nerves. Timepoint: Measurement of nerve conduction velocity at the beginning of the study (before the start of the study), 6 sessions after the intervention (2 weeks after the start of the treatment) and one month after the end of the treatment. Method of measurement: Measuring nerve conduction velocity by electromyography device.;Examining the presence of disorder or lack of sensation: Semmes-Weinstein 10g monofilament is used and different points (a total of 10 points) including three points on the plantar surface of the first, third and fifth toes, three points on the plantar surface of the first, third and metatarsal heads. Fifth, two points on the inner and outer sides of the middle part of the foot, one point on the heel area and one point on the back surface of the foot are evaluated. Timepoint: Measurement of sensory loss or disturbance at the beginning of the study (before the start of the intervention), 6 sessions after the treatment (2 weeks after the start of the treatment) and one month after the end of the treatment. Method of measurement: Monofilament test.;Michigan questionnaire to investigate neuropathy in diabetic patients :This questionnaire is for checking the presence of diabetic neuropathy and higher scores mean more severity of neuropathy. The first part, history, includes 15 questions about the sensations of pain, numbness, temperature, etc., which the patient answered and Each question has one mark. Of course, question 4 related to defective blood circulation and question 10, which are related to general weakness, are not included in scoring, and the maximum acquired score is 13. The second part includes a brief physical examination of the feet, which is not used in this study. Timepoint: Investigation of neuropathy at the beginning of the study (before the start of the intervention) and 6 sessions after the treatment (2 weeks after the start of the treatment) and one

Countries

Iran (Islamic Republic of)

Contacts

Public Contactminoo khalkhali zavieh

Shahid Beheshti University of Medical Sciences

faezeh_abaschian@yahoo.com+98 21 7754 2057

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026