Investigation of the clinical effectiveness of the tennis device in reducing menstrual pain
Design
Clinical trial with a control group, double-blind, randomized, phase 4 on 74 patients.
Settings and conduct
musculoskeletal research center, Isfahan university of medical sciences
Participants/Inclusion and exclusion criteria
1- Women 18-45 years old
2- History of pain during at least the last 3 cycles
3- moderate to severe pain (VAS ≤ 5) that is needed to take painkillers to relieve the pain.
Intervention groups
Experimental group:
Arnica tennis device manufactured by Avin Teb Isfahan Medical Engineering Company will be used for intervention. The intervention of one session will be done on the day of menstruation when the participant has the most pain. The pulse width and frequency of the output current are equal to 100 microseconds and 100 Hz, respectively. The size of the electrode area is 45 mm. The time to use the device will be 30 minutes. Participants lie on their side. If you feel pain in the lower abdomen, the self-adhesive electrode will be attached below the level of the navel on the clean and dry skin of the abdomen, and if you feel pain in the lower back, the electrode will be attached to the clean and dry skin of the lower back. To use the skin device, first the electrodes are attached to the skin and after making sure that the device is off, it is connected to the device by means of a connecting wire. Then the device is turned on and the intensity of the current increases to below the pain threshold. After the end of the usage time, the device is turned off and the electrodes are separated from the skin.
control group:
For the control (placebo) group, all the steps are the same as the test group, but a device that has no output is used.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230814059144N1
Registration date:2023-08-20, 1402/05/29
Registration timing:prospective
Last update:2023-08-20, 1402/05/29
Update count:0
Registration date
2023-08-20, 1402/05/29
Registrant information
Name
Ashraf Mahmoudzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5229
Email address
amahmoudzadeh58@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-26, 1402/06/04
Expected recruitment end date
2023-10-26, 1402/08/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation clinical effectiveness of the TENS device in reducing menstrual pain
Public title
effect of TENS on menstrual pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women 18-45 years old
History of pain during at least the last 3 cycles
moderate to severe pain (VAS ≤ 5) that was needed to take painkillers to relieve the pain.
Exclusion criteria:
History of lower abdominal surgery
Scars, wounds, abdominal skin sensitivity
Suffering from cancer, diabetes, heart, immunity, epilepsy and psychological diseases
Suffering from other women's diseases such as poly-cystic ovaries, endometriosis and uterine fibroid
Using a pacemaker
Age
From 18 years old to 45 years old
Gender
Female
Phase
4
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
According to the number of participants in the study plus 20%, code 1 and 2 will be considered. Code 1 will be for the control group and code 2 will be for the test group. Then the codes are written on small pieces of paper and the paper is folded. The folded papers are put into a container and one is randomly picked.
Blinding (investigator's opinion)
Double blinded
Blinding description
The inclusion and exclusion criteria of the study are evaluated by a physiotherapist unaware of the research method and based on clinical tests.
Since the names of the groups are written as codes 1 and 2 and the device is used as a placebo (no output) for the control group, the patients are blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Isfahan university of medical sciences
Street address
Isfahan University of Medical Sciences,Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2023-07-17, 1402/04/26
Ethics committee reference number
IR.ARI.MUI.REC.1402.092
Health conditions studied
1
Description of health condition studied
menstrual pain
ICD-10 code
N94
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
pain
Timepoint
before, immediately, one hour and 24 hours after the intervention
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention of one session will be done on the day of menstruation when the participant has the most pain. The pulse width and frequency of the output current are equal to 100 microseconds and 100 Hz, respectively. The size of the electrode area is 45 mm. The time to use the device will be 30 minutes. Participants lie on their side. If you feel pain in the lower abdomen, the self-adhesive electrode will be attached below the level of the navel on the clean and dry skin of the abdomen, and if you feel pain in the lower back, the electrode will be attached to the clean and dry skin of the lower back. To use the skin device, first the electrodes are attached to the skin and after making sure that the device is off, it is connected to the device by means of a connecting wire. Then the device is turned on and the intensity of the current increases to below the pain threshold. After the end of the usage time, the device is turned off and the electrodes are separated from the skin.
Category
Rehabilitation
2
Description
Control group: The procedure will be similar to the experimental group, but the device has no output
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic, Faculty of Rehabilitation Sciences
Full name of responsible person
Farnaz Jokar
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
3rd Floor, Unit 13 of Parsian Commercial, Between Aburihan and Falaturi Office Complex, Eshraq North Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8193914902
Phone
+98 31 3459 7621
Fax
+98 31 3459 7622
Email
info@avintebco.com
Web page address
https://avintebco.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Equipment Avin Teb
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ashraf Mahmoudzadeh
Position
Faculty commitments
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Nika Building, Azadegan Alley, Khosropur St, Hazar Jarib St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5229
Fax
Email
amahmoudzadeh58@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ashraf Mahmoudzadeh
Position
Faculty commitments
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Nika Building, Azadegan Alley, Khosropur St, Hazar Jarib St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5229
Fax
Email
amahmoudzadeh58@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ashraf Mahmoudzadeh
Position
Faculty commitments
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Nika Building, Azadegan Alley, Khosropur St, Hazar Jarib St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5229
Fax
Email
amahmoudzadeh58@gmail.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
The present study is carried out to confirm the effectiveness of the TENS device at the request of the industry, and its results will be reported to Avin Teb Medical Engineering Company in order to obtain the necessary license for mass production.