Protocol summary

Study aim
Investigating the effect of evening primrose oil phonophoresis on the symptoms of peripheral neuropathy in patients with type 2 diabetes
Design
A clinical trial with a control group, with parallel groups, one-sided blind
Settings and conduct
In this study, patients will be introduced to the physiotherapy clinic of Tehran Pars Hospital by neurology specialists of Tehran Pars Hospital. The method of intervention is that before the intervention, the soles and backs of the feet and fingers are treated with 3gr of the relevant lotions (Lino Derm, made by Barij Essan Company, containing 89% gammalinolenic acid), is smeared and covered with a pad on the desired position for 5 minutes. Next, the ultrasound device is performed for 8 minutes for each of the levels. After the intervention, the desired position is covered with a pad for 5 minutes. In the second group, on ultrasound is used with neutral ointment, and in the third group, Linoderm ointment is used alone with muted ultrasound
Participants/Inclusion and exclusion criteria
Patients with type 2 diabetes between 45-75 years old and with symptoms of neuropathy in the lower limbs that are diagnosed with the help of NCV. Exclusion criteria are the presence of neuropathy symptoms without the presence of diabetes, diabetic infectious wounds, systemic peripheral vascular problems, the presence of Chronic diseases such as coronary artery disease, chronic lung diseases, kidney problems, history of drug allergies and pregnancy, as well as unwillingness to cooperate.
Intervention groups
The first group, (13 feet) use of bright ultrasound with a neutral and ineffective ointment, the second group, (13 feet) use of light ultrasound with linoderm ointment and the third group, (13 feet) use of linoderm ointment alone And with ultrasound off.
Main outcome variables
Pain scale by numerical rating scale questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200125046249N1
Registration date: 2024-04-30, 1403/02/11
Registration timing: prospective

Last update: 2024-04-30, 1403/02/11
Update count: 0
Registration date
2024-04-30, 1403/02/11
Registrant information
Name
Faezeh Abaschian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 7971
Email address
faezeh_abaschian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2025-01-04, 1403/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effectiveness of evening primrose with the help of ultrasonic waves on the symptoms of peripheral neuropathy in people with type 2 diabetes
Public title
The effect of evening primrose with the help of ultrasound waves on neuropathy symptoms of type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 39
More than 1 sample in each individual
Number of samples in each individual: 2
Each person consists of two legs
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible cases were randomly assigned to three group by block randomization. A block size of six was used for randomization, and the sequences were calculated by Random allocation software v. 2.0.The research coordinator had exclusive access to the numbered, sealed envelopes that indicated each patient’s randomized treatment assignment.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients do not know which group they are in and what intervention they are receiving.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Imam Hossein (AS) Square, Damavand Street (New Tehran), in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Approval date
2018-04-25, 1397/02/05
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.205

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
G63.2
ICD-10 code description
Diabetes mellitus with polyneuropathy

Primary outcomes

1

Description
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 outcomes

1

Description
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

2

Description
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

3

Description
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 month after the end of the treatment.
Method of measurement
Michigan questionnaire

Intervention groups

1

Description
Intervention group: Using plug in ultrasound along with an ineffective ointment
Category
Rehabilitation

2

Description
Intervention group: Using plug in ultrasound along with Linoderm ointment
Category
Rehabilitation

3

Description
Control group: Using Linoderm ointment alone and with the ultrasound turned off
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Department of Tehranpars Hospital, Tehran
Full name of responsible person
Minoo Khalkhali zavieh
Street address
Imam Hossein (AS) Square, Damavand Street (New Tehran), in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
minoo_kh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoo Khalkhali Zavieh
Street address
Imam Hossein (AS) Square, Damavand Street (New Tehran), in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
minoo_kh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
minoo khalkhali zavieh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Imam Hossein (AS) Square, Damavand Street (New Tehran), in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
faezeh_abaschian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
minoo khalkhali zavieh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Imam Hossein (AS) Square, Damavand Street (New Tehran), in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
faezeh_abaschian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
minoo khalkhali zavieh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Imam Hossein (AS) Square, Damavand Street (New Tehran), in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
faezeh_abaschian@yahoo.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
Loading...