The Effect of Cupping on Pain and Force of Hand in Carpal tunnel Syndrome
Design
Randomized trial with control group, parallel and block randomization on 60 patients.
Settings and conduct
This research will be done on 60 patients with Carpal Tunnel Syndrome who refer to sports medicine clinic in Imam Hossein hospital. Patients will be divided into 2 groups: control group will be treated by splint and exercise and intervention group will be treated by splint, exercise and cupping on the side of Carpal Tunnel. Pain, hand force and quality of life will be measured before and after study. Pain will be measured by VAS score, hand force will be tested by hand-gripe dynamo-meter and quality of life will be measured by Boston Carpal Tunnel Questioner (BCTQ).
Participants/Inclusion and exclusion criteria
All patients with mild or moderate Carpal Tunnel that candidate for conservative therapy can entrance; Patient with sever type can't entrance
Intervention groups
Control group will be treated by splint and exercise. Intervention group will be treated by splint, exercise and cupping.
Main outcome variables
Pain and hand force
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200419047130N1
Registration date:2020-05-02, 1399/02/13
Registration timing:registered_while_recruiting
Last update:2020-05-02, 1399/02/13
Update count:0
Registration date
2020-05-02, 1399/02/13
Registrant information
Name
Seyedeh Mohadeseh Taheri Otaghsara
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 3849
Email address
smtaheri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-26, 1399/02/07
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cupping on Pain and Hand Force in Carpal Tunnel Syndrome’s Patients
Public title
"Effect of Cupping in Carpal Tunnel Syndrome"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Patients With Mild or Moderate Type of Carpal Tunnel Syndrome
Exclusion criteria:
All patients With Sever Type of Carpal Tunnel Syndrome
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
We will create quadruple blocks to assign patients equally in groups. The block size will be 4, so we will make 6 possible sequences including: abab, bbaa, aabb, baab, abba, baba and we will select the order of blocks randomly using software (a means intervention group and b means control group).
Blinding (investigator's opinion)
Not blinded
Blinding description
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 Science
Street address
Shahid Chamran HWY., Yaman Ave.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.SBMU.MSP.REC.1398.087
Health conditions studied
1
Description of health condition studied
Carpal Tunnel Syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
Pain scale with Visual Analogue Scale
Timepoint
Before and after intervention (6 weeks later)
Method of measurement
Visual Analogue Scale
2
Description
Hand gripe force
Timepoint
Before and after intervention (6 weeks later)
Method of measurement
Hand-gripe Dynamo-meter
Secondary outcomes
1
Description
Quality of life scale
Timepoint
Before and after intervention (6 weeks later)
Method of measurement
Boston Carpal Tunnel Questionnaire
Intervention groups
1
Description
Intervention group: Patients use cupping device( Beijing kangzho baganq) that made in China. Diagonal length of cup depends the patient will be 30% to 50% of ventral surface of the wrist. Cup use for 20 minutes every session and twice a week for 5 weeks. All patient have to use cock up splint during night and do exercise (Tendon and Nerve Gliding). They must do exercise for 5 seconds, 10 repetitions, 2 sets and every day. Pain, hand force and quality of life measure before and 6 weeks after the beginning of the study.
Category
Treatment - Devices
2
Description
Control group:patients have to use cock up splint during night and do exercise (Tendon and Nerve Gliding). They must do exercise for 5 seconds, 10 repetitions, 2 sets and every day. Pain, hand force and quality of life measure before and 6 weeks after the beginning of the study.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospial
Full name of responsible person
Shahin Salehi
Street address
Shahid madani Ave., Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 8009
Email
smtaheri1986@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Chamran HWY., Yaman Ave.,Shahid Beheshti University of Medical Science
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?