To evaluate the effect of perineural and acupoints hypertonic saline5% injection in diabetic neuropathy
Design
A double blinded randomized controlled clinical trial with a parallel group design of 30 patients. Randomization sequence was created by the computer with the block size of six.
Settings and conduct
In this study, 30 patients with diabetic neuropathy who are eligible for entering the study will be randomly divided into two groups of 15, in the first group heypertonic saline is injected perineural and in the second group at the site of acupoints.Both the patients and analyzer are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diabetic patients with neuropathic pain in the past 3 months, ages between 30-60 years
Exclusion criteria: any infection, tumor or cutaneous lesions at or near sites of injection, significant foot deformity, history of chemotherapy, pregnancy, lumbosacral canal stenosis, discopathy, trauma, collagen vascular disease, nerve injury or other types of neuropathy, history of coagulopathy or bleeding tendency and allergy to the medication used in trial
Intervention groups
The first group will receive hypertonic saline injection near the nerves of Sural, Peroneal and Tibial. In the second group hypertonic saline will be injected at the site of acupoints(St-44, ST41, GB-40 )
Main outcome variables
Main outcome measures include neuropathy and the score of Douleur Neuropathique 4 questionnaire(DN4)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170517034008N1
Registration date:2019-04-07, 1398/01/18
Registration timing:retrospective
Last update:2019-04-07, 1398/01/18
Update count:1
Registration date
2019-04-07, 1398/01/18
Registrant information
Name
Nina Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 9040
Email address
nheidari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-11, 1397/06/20
Expected recruitment end date
2019-05-10, 1398/02/20
Actual recruitment start date
2018-04-09, 1397/01/20
Actual recruitment end date
2019-01-29, 1397/11/09
Trial completion date
2019-02-19, 1397/11/30
Scientific title
Efficacy of perineural hypertonic saline injection versus acupoints of foot in the management of diabetic neuropathy: a randomized clinical trial
Public title
Effect of hypertonic saline injection in diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of pain, paresthesia and sympoms of diabetic neuropathy over the past month
Ages between 30-60
Complete and sign written consent
Exclusion criteria:
Infection, tumor or any skin lesions at the site of intervention
Severe foot deformity
History of chemotherapy
Pregnancy
Lumbosacral canal stenosis or discopathy
Trauma
Rheumatologic and collagen vascular disease(CVD)
Spinal cord injury(SCI)
Traumatic brain injury(TBI)
Cerebrovascular accident(CVA)
Other nerve injuries and neuropathies
History of coagulopathy disorders
History of allergy to the drugs being used in the study
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Thirty eligible patients will be randomly allocated to two parallel groups (Perineural injection group or G1 and acupoints injection group or G2). Randomization sequence is created using Excel 2007 (Microsoft) with a random block size of six.
Blinding (investigator's opinion)
Double blinded
Blinding description
We will perform a double blinded study. In both groups there are equal volume and appearance of the drug and the patients have no ideas about injection sites of the groups. Also the analyst does not have any knowledge about the type of intervention in each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Ethic committee in medical research, Vice Chancellor for research, 7th floor, Central building of Shiraz University of Medical sciences, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2018-06-18, 1397/03/28
Ethics committee reference number
IR.SUMS.MED.REC.1397.132
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
The primary outcome is an assessment tool for neuropathic pain, called Douleur Neuropathique 4 questionnaire(DN4) score.
Timepoint
For each subject, the Douleur Neuropathique 4 questionnaire outcome measure is completed at baseline, first, second and 8th week after treatment.
Method of measurement
Douleur Neuropathique 4 questionnaire to assess neuropathic pain.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The study solution consisted of 5 mL sodium chloride hypertonic 5% and 1 mL lidocaine 2% (Pasteur institute of Iran) was injected with a 27-gauge needle near the tibial, saphenous and sural nerves (based on anatomical landmarks) under sterile condition.(Two milliliters of the study solution were injected in each point.)
Category
Rehabilitation
2
Description
Intervention group 2: we defined three acupuncture points based on the relevant literature, including ST-41, ST-44 and GB-40.The study solution consisted of 5 mL sodium chloride hypertonic 5% and 1 mL lidocaine 2% (Pasteur institute of Iran) was injected with a 27-gauge needle and two milliliters in each point.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi hospital
Full name of responsible person
Nina Heidari
Street address
Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Fax
+98 71 3233 1634
Email
nheidari@sums.ac.ir
2
Recruitment center
Name of recruitment center
Emam Reza clinic
Full name of responsible person
Nina Heidari
Street address
Namazi SQ
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3212 7001
Email
nheidari@sums.ac.ir
3
Recruitment center
Name of recruitment center
Shahid Motahari clinic
Full name of responsible person
Nina Heidari
Street address
Namazi SQ
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3612 1000
Email
nheidari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yunes Ghasemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Nina Heidari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Faghihi hospital, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3231 9040
Fax
+98 71 3623 0865
Email
nheidari@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nina Heidari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Faghihi hospital, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3231 9040
Fax
+98 71 3623 0865
Email
nheidari@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nina Heidari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Faghihi hospital, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3231 9040
Fax
+98 71 3623 0865
Email
nheidari@sums.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