evaluate the effects of carboxytherapy on the signs and symptoms of sensory neuropathy in diabetic patients.
Design
Sample Size: 50 patients
Study population: Patients with diabetic sensory neuropath
Calculation the sample size: Due to the pilot nature of the study and the facilities of the research team
Sampling Method: Targeted
Data collection technique: Observation and interview
This study was performed in a pre-and post-intervention design.
Repeated measures linear model (repeated measures ANOVA) or Friedman test was used to analyze data and compare the outcomes between the study groups at three follow-up stages (for the data fulfilling normal distribution). Statistical analysis was performed using IBM SPSS software version 16.
Settings and conduct
Fifty patients entered the study, each participant received highly concentrated CO2-enriched water once a day for 15 days and then once a week for three months. The prevalence of neuropathy-related signs and symptoms was assessed using the Michigan Neuropathy Screening Instrument (MNSI) and the Visual Analogue Scale (VAS) questionnaires, before, after 15 sessions and after 3 months.
Participants/Inclusion and exclusion criteria
Patients with diabetic sensory neuropathy referring to the endocrinology clinic of Loghman e Hakim Hospital, who have been suffering from type 1 or type 2 diabetes for more than 5 years.
Non-entry conditions:
The patient's unwillingness to participate in the study
Diabetic motor neuropathy
Age below 20 and above 70 years
Having neuropathy due to other causes of neuropathy
Intervention groups
The patients placed their feet in a CO2-enriched water bath (39°C, the concentration of 1100 ppm)
Main outcome variables
CO2-enriched water; Score of Michigan Neuropathy Screening Questionnaire in three follow-up periods; Intensity of numbness, burning pain, muscle cramp in three follow-up periods
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220814055686N1
Registration date:2023-03-06, 1401/12/15
Registration timing:retrospective
Last update:2023-03-06, 1401/12/15
Update count:0
Registration date
2023-03-06, 1401/12/15
Registrant information
Name
Safoura Alsadat Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4634 2056
Email address
safura.b.hoseini@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
2019-05-05, 1398/02/15
Actual recruitment end date
2020-02-04, 1398/11/15
Trial completion date
2020-06-19, 1399/03/30
Scientific title
The effect of high concentration CO 2 -enriched water on sensory neuropathy in patients with diabetes
Public title
The effect of high concentration CO 2 -enriched water on sensory neuropathy in patients with diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diabetic patiente with diabetic sensory neuropathy
Exclusion criteria:
Unwillingness to participate in the study
Age of <20 and >70 years
The diagnosis of diabetic motor neuropathy
Neuropathy secondary to other causes
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
No. 2, Arabi Ave., Velenjak St
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-10-27, 1397/08/05
Ethics committee reference number
IR.SBMU.MSP.REC.1397.805
Health conditions studied
1
Description of health condition studied
Diabetic sensory neuropathy
ICD-10 code
E08.40
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Diabetic Sensory Neuropathy
Timepoint
At the beginning of the study, after 15 sessions and after three months of using co2-enriched water
Method of measurement
Michigan Neuropathy Screening Instrument (MNSI) and the Visual Analogue Scale (VAS) questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the Michigan Neuropathy Screening Instrument (MNSI) (10) and the Visual Analogue Scale (VAS) questionnaires were completed by patients. Then, patients placed their feet in a CO2-enriched water bath (39°C, the concentration of 1100 ppm) daily for 15 days and 30 minutes each time. After completing the sessions, patients were re-evaluated and filled out the questionnaires again to record possible changes. Sessions were set once a week for three months (30 minutes at each session), and then the patients underwent the same examinations again to detect any change in patient’s symptoms.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman e Hakim hospital
Full name of responsible person
Doctor Saied Kalbasi
Street address
Makhsous Ave., Lashkar Squ., Loghman e Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Fax
Email
loghman.hospital@sbmu.ac.ir
Web page address
https://lhmc.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Doctor Afshin Zarghi
Street address
No. 2, Arabi Ave., Velenjak St
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Web page address
http://research.sbmu.ac.ir
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
Saeid Kalbasi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology
Street address
Makhsous Ave., Lashkar Squ., Loghman e Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
saeid_kalbasi@yahoo.com
Web page address
https://lhmc.sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeid Kalbasi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Makhsous Ave., Lashkar Squ., Loghman e Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
saeid_kalbasi@yahoo.com
Web page address
https://lhmc.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeid Kalbasi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Makhsous Ave., Lashkar Squ., Loghman e Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
saeid_kalbasi@yahoo.com
Web page address
https://lhmc.sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Questionnaires filled by patients are for sharing.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
There is no limit
From where data/document is obtainable
Refer to Loghman e Hospital. Dr. Saeid Kalbasi.
Number: 0098 21 5541905
What processes are involved for a request to access data/document