Determination of the effect of acupuncture on the symptoms of diabetes-related peripheral neuropathy (DPN).
Design
The clinical trial with two groups (intervention and control), pragmatic, one-blind, randomized
Settings and conduct
This study will be conducted to evaluate the effect of acupuncture on the symptoms of diabetes-related peripheral neuropathy (DPN) in a specialized clinic of Vasesi Hospital in Sabzevar. Patients will be randomly assigned to the intervention and placebo group. Pain evaluation is done by using a visual analog scale measurement scale for the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with their neuropathy are caused by type 1 and type 2 diabetes, Patients with a pain score of 3 or more are in the form of an assessment of the visual scale of the pain, Patients aged 40 to 60 years, Patients with at least 10 years of diabetes.
Exclusion criteria: Patients with a diabetic foot ulcer, Patients who drink alcohol or use tobacco, Patients who use immunosuppressive drugs have interfered with the interpretation of results, Patients whose neuropathy is caused by other disorders, such as carpal tunnel syndrome, AIDS, etc., Unwillingness to complete questionnaires and do acupuncture.
Intervention groups
Intervention group: In addition to routine therapies, will be treated with real acupuncture as a complementary therapy for seven sessions and once a week for 20 minutes each session. These points are marked with standard stainless needles and stimulated for 20 minutes manually for acupuncture stimulation elicits (DEQI).
Control group: The control group will only be treated under the usual treatment of neuropathy and sham acupuncture for seven sessions and once a week. And points are at least 1.5 centimeters away from the 9 main real acupuncture points will be used.
Main outcome variables
Determine the amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181006041252N13
Registration date:2019-06-27, 1398/04/06
Registration timing:registered_while_recruiting
Last update:2019-06-27, 1398/04/06
Update count:0
Registration date
2019-06-27, 1398/04/06
Registrant information
Name
Mohammad Sahebkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8337
Email address
sahebkarm@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-26, 1398/04/05
Expected recruitment end date
2019-08-27, 1398/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of acupuncture on the symptoms of diabetes-related peripheral neuropathy (DPN).
Public title
The effect of acupuncture on the symptoms of diabetes-related peripheral neuropathy (DPN).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with their neuropathy are caused by type 1 and type 2 diabetes
Patients with a pain score of 3 or more are in the form of an assessment of the visual scale of the pain.
Patients aged 40 to 60 years.
Patients with at least 10 years of diabetes.
Exclusion criteria:
Patients with diabetic foot ulcer
Patients who drink alcohol or use tobacco.
Patients who use immunosuppressive drugs have interfered with the interpretation of results.
Patients whose neuropathy is caused by other disorders, such as carpal tunnel syndrome, AIDS, etc.
Unwillingness to complete questionnaires and do acupuncture
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was conducted based on a permutation block by a statistical consultant using random allocation software and the output sequences A and B are available to the researcher, Accordingly, 13 blocks were allocated to patients, in each block, 2 from A treatment group, 2 from the B treatment group were placed. Eventually, after completing the blocks group A was treated with Group A is treated with acupuncture and Group B is being treated with placebo (sham acupuncture). First, we determine all sixsome modes in which two individuals are assigned to group A and two to group B. Then we assign one of the digits 1 to 6 to each of the sixsome combinations (which includes thirty-six modes). In the next step, we must randomly select 13 blocks of six and write their combinations in succession. For this we have to make 13 samplings with replacement from a six-member community; 6 times, choose a random number between 1 and 6 and this process will continue until the end of the sampling and the difference between the two groups will not exceed a maximum of two (half the size of the block).
Blinding (investigator's opinion)
Single blinded
Blinding description
Each person in the study will be assigned code A and B, that the researcher will only be known of the type of groups. Participants are unaware of the groups. It should be noted that acupuncture and placebo (sham acupuncture) are similar in appearance, color, and packaging.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2019-06-15, 1398/03/25
Ethics committee reference number
IR.MEDSAB.REC.1398.023
Health conditions studied
1
Description of health condition studied
Diabetes-related peripheral neuropathy (DPN).
ICD-10 code
E08.40
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Determine the amount of pain
Timepoint
Measuring the amount of pain at the beginning of the study (before the intervention) and at the end of each session for seven sessions (weekly) after the start of the intervention.
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Determine fatigue
Timepoint
Fatigue measurement at the beginning of the study (before the intervention) and at the end of each session for seven sessions (weekly) after the start of the intervention.
Method of measurement
Multidimensional Fatigue Inventory-20= MFI-20
Intervention groups
1
Description
Intervention group: The treatment group, in addition to routine therapies, will be treated with real acupuncture as a complementary therapy for seven sessions and once a week for 20 minutes each session. Treatment in this group will be in 9 specific areas of the body. These points are marked with standard stainless needles (0.3 mm diameter, 40 mm length, Korea) and stimulated for 20 minutes manually for acupuncture stimulation elicits (DEQI). During the study period, each week will be evaluated for the improvement of neuropathy symptoms.
Category
Treatment - Other
2
Description
Control group: The control group will only be treated under the usual treatment of neuropathy and sham acupuncture. Acupuncture will be unrealistic for seven sessions and once a week. In this study, we will use the Streitberger devices. The needle is not fixed inside the copper cloth and the tip is blunt, and when it touches the skin, the feeling of itching is felt in the patient (simulating skin piercing). For the sham acupuncture group, points that are at least 1.5 centimeters away from the 9 main real acupuncture points will be used. During the study period, each week will be evaluated for the improvement of neuropathy symptoms.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei hospital
Full name of responsible person
Mohammad Sahebkar
Street address
Vasei Hospital, Asadabady Ave., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1014
Email
Vasei.h@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshte Ghorat
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Email
Drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Sahebkar
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8337
Email
Mohammad.Sahebkar66@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Najmeh Rahimi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinologist and Metabolism
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8337
Email
rahimy.najmeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Sahebkar
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8337
Email
Mohammad.sahebkar66@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD