Comparison of therapeutic effects of nerve and tendon gliding exercise, ultrasound and kinesiotaping on clinical outcomes of carpal tunnel syndrome
Design
A randomized, parallel group clinical trial with blinded researcher and evaluators, design of 100 wrists. simple randomization with envelope.
Settings and conduct
This research is a double-blind, control clinical trial. This research is carried out at the Tehran University of Medical Sciences Rehabilitation Faculty Research Center. In this research, a pilot and reliability study will be conducted than main research will be done. Subjects enter the research after completing the consent form, understanding of how to do the research and having the inclusion criteria . Individual information is collected by questionnaire. After randomization, each subject is placed in one of three intervention groups. Median nerve ultrasound findings and electrodiagnostic are collected before intervention. For the intervention group, nerve and tendon gliding exercise, ultrasound and kinesiotaping are used. Then therapeutic session reassessment takes place. In this study, participants, data collectors and data analyzers are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Subjects aged 20 - 60 years with mild and moderate carpal tunnel syndrome. Exclusion criteria: Allergic sign of kinesiotaping, Taking painkiller during research
Intervention groups
nerve and tendon gliding exercise, ultrasound and kinesiotaping
Main outcome variables
Pain intensity, symptom Severity , Functional Status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090301001722N23
Registration date:2020-03-05, 1398/12/15
Registration timing:registered_while_recruiting
Last update:2020-03-05, 1398/12/15
Update count:0
Registration date
2020-03-05, 1398/12/15
Registrant information
Name
Samira Karimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
hadianrs@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effects of nerve and tendon gliding exercise, ultrasound and kinesiotaping on clinical outcomes of carpal tunnel syndrome
Public title
Comparison of physiotherapy methods on symptoms of Carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with mild and moderate carpal tunnel syndrome- age of 20–60 years
have no disorders like Hypothyroidism, Gout, Systemic Lupus Erythematosus, rheumatoid arthritis, diabetes mellitus, chronic renal failure, and acromegaly
have no history of using analgesic drugs to relieve CTS over the past two weeks
have no history of wrist fracture and repetitive trauma to the hand
have no history of CTS surgery
not pregnant
have no any orthopedic or neurologic disorders mimicking CTS such as polyneuropathy, cervical radiculopathy, brachial plexopathy,thoracic outlet syndrome
have no corticosteroid injection into the carpal tunnel in the last three months
No physiotherapy for CTS in the past 6 month
Exclusion criteria:
Patients who were not willing to continue the study for any reason.
Allergic sign of kinesio taping
Taking painkiller during research
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The patients randomly will be divided into three groups by closed envelope method. The allocation of the subjects will be concealed by using sequentially numbered, sealed and opaque envelopes. On the first day of treatment, the envelope allocated will be opened by participant
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the investigator will beblind to the results of all pre- and post-treatment evaluations, also all three evaluators will be blind to each other's results and any patient is located in which intervention group. The data analyzer as a statistics consultant will be also blind. It is not possible to blind patients in this study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz bolvar, Ghods Ave, 6 floor, Tehran University of Medical Science building
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-01-25, 1398/11/05
Ethics committee reference number
Ir.tums.vcr.rec.1398.836
Health conditions studied
1
Description of health condition studied
carpal tunnel syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity
Timepoint
Before and after therapeutic sessions
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Symptom Severity
Timepoint
Before and after therapeutic sessions
Method of measurement
Boston questionnaire
3
Description
Functional Status
Timepoint
Before and after therapeutic sessions
Method of measurement
Boston questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ultrasound: We use pulse ultrasound with a 5 cm probe, frequency of 1 MHz and intensity 1 W / cm2 (1: 4 ratio) for 10 minutes on the anterior part of the wrist (carpal tunnel). Treatment sessions are performed once a day, 5 sessions per week for three weeks.
Category
Treatment - Devices
2
Description
Intervention group: taping: we use tape with 5 cm wide and 0.5 mm thick. Thetape is kept on the patient for 3 days and after two days rest, the tape is applied again for 3 days. This will be repeated for up to 3 weeks.
Category
Treatment - Devices
3
Description
Intervention group: Tendon and nerve gliding exercises are performed according to the Totten and Hunter method in 3 sets of 10 exercises per day for three weeks.
Category
Rehabilitation
4
Description
Control group: TENS and Infrared: Normal TENS for 20 minutes, infrared for 20 minutes to the anterior part of the wrist.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation cilinic of Tehran University of Medical Science
Full name of responsible person
Dr Mohsen Mir
Street address
Engheleb Ave
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 5132
Email
alieh_rezazadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Ali Sohrabpour
Street address
Keshavarz Blvd, Tehran University of Medical Science
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8893 3767
Email
alieh_rezazadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Hadian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Engheleb Ave, Rehabilitation School
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 6586
Email
hadianrs@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammah Reza Hadian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Engheleb Ave, Rehabilitation School
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 6586
Email
hadianrs@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alieh Rezazadeh
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Engheleb Ave, Rehabilitation School
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 5132
Email
alieh_rezazadeh@yahoo.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
All rights of this research belongs to TUMS.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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