Comparison of the effect of 4 weeks of cuping and kinesiotype on changing the symptoms of carpal tunnel syndrome during pregnancy (ultrasonography)
Design
Pregnant bread will be divided into two groups: kinesiotype and cuping after being diagnosed with CTS. In the caping group, air cupping will be used in the anterior region of the hand. These treatments will last for 8 sessions and two Day to week and in total for 4 weeks.In the kinesiotype group, the I-shaped kinesiotype strip will be measured from the proximal palmar fold to the internal epicondyle of the humerus, then a Y-section will be made on the kinesiotype strip.
Settings and conduct
In this clinical trial, 30 pregnant women (30 hands) with carpal tunnel syndrome will be selected from among the patients referred to the gynecology clinic of the 3rd Shaban Hospital with the diagnosis of a gynecologist with an age range of 20 to 35 years.
Participants/Inclusion and exclusion criteria
Entry requirements:1- The examinees are in the third trimester of pregnancy
2- The examinees are in the age range of 20 to 35 years
3- Dominant hand with carpal tunnel syndrome
No entry conditions: 1- History of injury due to trauma to the median nerve or wrist such as bruises, fractures
2- Tested people should have CTS before pregnancy
3- Multiple births
4- Skin sensitivity to kinesiotype in some subjects
Intervention groups
In the caping group, air cupping was used in the anterior region of the hand.
In the kinsio taping group, A kinesiotype I-shaped band was measured from the proximal palmar fold to the internal epicondyle of Homer. A Y-slice was then made on the kinesiotype strip.
Main outcome variables
Pain intensity, Boston questionnaire symptom severity, Boston questionnaire functional status, median nerve cross section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151128025265N3
Registration date:2021-05-12, 1400/02/22
Registration timing:registered_while_recruiting
Last update:2021-05-12, 1400/02/22
Update count:0
Registration date
2021-05-12, 1400/02/22
Registrant information
Name
Sedigheh Sadat Naimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1411
Email address
naimi.se@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-02, 1400/01/13
Expected recruitment end date
2022-09-20, 1401/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of 4 weeks of caping and kinesiotype on reducing the symptoms of carpal tunnel syndrome during pregnancy (ultrasonography)
Public title
Comparison of the effect of 4 weeks of cuping and kinesiotype in patients with carpal tunnel syndrome during pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The subjects are in the third trimester of pregnancy
The subjects are in the age range of 20 to 35 years
Dominant hand with carpal tunnel syndrome
Ultrasonographic findings should be positive in all subjects (increase in median cross-sectional area of more than 9 mm2)
Exclusion criteria:
History of trauma to the median nerve or wrist such as bruises, fractures
Pre-pregnancy test takers have CTS
Multiple births
Skin sensitivity to kinesiotype in some subjects
Diabetes
Rheumatoid Arthritis
Hypothyroidism
Premature delivery of a volunteer
Discontinue patient cooperation
Irregularities in referrals
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Pregnant women with CTS in the third trimester of pregnancy were selected by simple and available sampling and randomly divided into two groups:
kinesiotype (n: 15) and group (n: 15). In this study, for random allocation, the coin tossing method was used in such a way that one group is considered a lion and one group is considered a line and the number of coin samples is tossed and individuals are randomly assigned to two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients did not know the study groups.
Placebo
Not 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
Tehran - Imam Hossein (AS) Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Approval date
2017-07-28, 1396/05/06
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.570
Health conditions studied
1
Description of health condition studied
carpal tunnel syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of symptoms
Timepoint
Immediately before and immediately after the intervention
Method of measurement
Boston Questionnaire
2
Description
Functional status
Timepoint
Immediately before and immediately after the intervention
Method of measurement
Boston Questionnaire
3
Description
Transverse cross section of median nerve
Timepoint
Immediately before and immediately after the intervention
Method of measurement
ultrasonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the caping group, air cupping will be used in the anterior region of the hand, and to create a vacuum, a hand pump equipped with a monitor (Gauge) will be used to adjust the pressure in millimeters of mercury. These treatments will be performed for 8 sessions two days a week for a total of 4 weeks. Under the edge of the cup, ultrasound gel without therapeutic properties will be used for better adaptation of the cup for patients.
Category
Rehabilitation
2
Description
In this group, the treatment will be done for 4 weeks, so that in each week, subjects will receive 3 days of kinesiotype as fascia technique. Then they will receive one day without kinesiotype and then another 3 days of kinesiotype. The I-shaped kinesiotype tape will be measured from the proximal palmar fold to the medial epicondyle of the humerus, then a Y-shaped cut will be made on the kinesiotype tape. The patient's elbow and wrist will be extended (complete stretch with the patient's other hand). The base of Y-shaped cut will be attached to the proximal palmar fold and the medial proximal tail will be attached in the direction of the medial epicondyle of the humerus with moderate tension (50% initial tension). Then, another I kinesiotype I tape with technique space with 25% tension will be used for dorsal wrist above the ulnar and radius.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation, Shahid Beheshti University of Medical Science
Full name of responsible person
Sedigheh Sadat Naimi
Street address
Damavand St., in front of Bouali Hospital, Shahid Beheshti Rehabilitation Faculty
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
naimi.se@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9331
Fax
+98 87 95008
Email
zarghi@sbmu.ac.ir
Web page address
https://isid.research.ac.ir/Afshin_Zarghi
Grant name
Shahid Beheshti University of Medical Science
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dr. Afshin Zarghi
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
Sedighe Sadat Naimi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tehran - Imam Hossein Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Science
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
naimi.se@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedighe Sadat Naimi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tehran - Imam Hossein Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Science
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
naimi.se@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedighe Sadat Naimi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tehran - Imam Hossein Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Science
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
naimi.se@gmail.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