1. Home
  2. Approved trials
  3. » فارسی

The effectiveness of shock wave therapy versus phonophoresis on improvement of clinical symptoms and function of patients with mild and moderate carpal tunnel syndrome

Protocol summary

Study aim
The effectiveness of shock wave therapy versus phonophoresis on improvement of clinical symptoms and function of patients with mild and moderate carpal tunnel syndrome(CTS)
Design
A randomized controlled clinical trial with three parallel, double-blind groups
Settings and conduct
Sampling was done by non-probability sequential method. Sixty CTS patients were selected from patients referred to physical medicine clinics of Al-Zahra, Kashani, Issa bin Maryam and Khorshid hospitals in Isfahan, Iran. Controls).Patients were unaware of the research and statistical purposes of the study and how the treatments were compared, and data were provided to the data analyzer after being anonymized.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with mild to moderate CTS who had mild to moderate CTS based on sensory and motor CTS examinations, Tinel and Falen tests, and electrodiagnostic findings. Willingness to participate in the study Non Inclusion criteria: Corticosteroid injection at 3 months prior to study Physical or medicinal modalities in the past 3 months Underlying conditions such as hypothyroidism, diabetes mellitus, rheumatic diseases, wrist arthritis, acute trauma or pregnancy Ultrasound and in vivo shock (pregnancy, acute inflammation, plastic implant, near pacemaker, on epiphysis, near the spinal cord or laminectomy site) History of surgery or fracture of the wrist area
Intervention groups
This study was performed on three groups of 20 patients. A sham vivo treatment group (with splint), a phonophoresis treatment (with splint), and a control group were treated with splint and medication to assess pain and function before treatment, one and two months after treatment, and evaluated with each other. compared.
Main outcome variables
Pain, Function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171230038142N10
Registration date: 2019-08-17, 1398/05/26
Registration timing: retrospective

Last update: 2019-08-17, 1398/05/26
Update count: 0
Registration date
2019-08-17, 1398/05/26
Registrant information
Name
Khosro Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9134
Email address
tavakol@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-06, 1398/02/16
Expected recruitment end date
2019-06-06, 1398/03/16
Actual recruitment start date
2019-05-06, 1398/02/16
Actual recruitment end date
2019-06-10, 1398/03/20
Trial completion date
2019-06-10, 1398/03/20
Scientific title
The effectiveness of shock wave therapy versus phonophoresis on improvement of clinical symptoms and function of patients with mild and moderate carpal tunnel syndrome
Public title
The effectiveness of shock wave therapy versus phonophoresis on improvement of clinical symptoms and function of patients with carpal tunnel syndrome(CTS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who had mild to moderate CTS with sensory and motor examinations, Tinel and Falun tests, and electrodiagnostic findings for more than a month. Willingness to participate in the study
Exclusion criteria:
Corticosteroid injection at least 3 months before the study Physical or medicinal modalities in the past 3 months Underlying conditions such as hypothyroidism, diabetes mellitus, rheumatic diseases, wrist arthritis, acute trauma or pregnancy Ultrasound and in vivo shock (pregnancy, acute inflammation, plastic implant, near pacemaker, on epiphysis, near the spinal cord or laminectomy site) History of surgery or fracture of the wrist area
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was done by non-probability sequential method. Sixty CTS patients were selected from patients referred to physical medicine clinics of Al-Zahra, Kashani, Issa bin Maryam and Khorshid hospitals in Isfahan, Iran. Controls).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were unaware of the research and statistical purposes of the study and how the treatments were compared, and data were provided to the data analyzer after being anonymized.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave., Isfahan University of Medical Sciences.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-05-05, 1398/02/15
Ethics committee reference number
IR.MUI.MED.REC.1398.035

Health conditions studied

1

Description of health condition studied
Carpal Tunnel Syndrome
ICD-10 code
S64
ICD-10 code description
Injury of nerves at wrist and hand level

Primary outcomes

1

Description
Pain
Timepoint
Before, one month and two months after intervention
Method of measurement
Using Visual Analogue Scale questionnaire

2

Description
Function
Timepoint
Before, one month and two months after intervention
Method of measurement
Using the Bostone Status and Performance Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Includes 20 patients with carpal tunnel syndrome who in addition to thermoplastic varicella splint at 0 to 5 degrees extension for 4 weeks for overnight use and vitamin B1 tablet 300 mg daily for 30 days, 4 sessions of focus view shock, starting With energy of 0.05 and increase based on patient and protocol tolerance up to 0.07, 0.1 and 0.15 as well as start with shock number 800 and increase based on patient tolerance and protocol up to 900, 1000 and 1100 and with frequency They received 3 Hz per session.
Category
Treatment - Devices

2

Description
Intervention group: Includes 20 patients with carpal tunnel syndrome who, in addition to thermoplastic splenic splint at 0 to 5 degrees of extension for 4 weeks for overnight use and vitamin B1 tablets 300 mg daily for 30 days, for two weeks, one day between and Each day for 15 minutes, they were pulsed (1 to 4) with 1 MHz frequency and 1 w / cm2 with 1% hydrocortisone ointment.
Category
Treatment - Devices

3

Description
Control group: Including 20 patients with carpal tunnel syndrome who received only thermoplastic varicella splint at 0 to 5 degrees for 4 weeks for overnight use and vitamin B1 tablets 300 mg daily for 30 days.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital in Isfahan
Full name of responsible person
Shila Haghighat
Street address
Kashani Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
Haghighatshila@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Vice-Chancellor for Research of School of Medicine,. Isfahan University of Medical Sciences,. Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shila Haghighat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
Haghighatshila@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shila Haghighat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
Haghighatshila@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shila Haghighat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
Haghighatshila@gmail.com

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
All information is shared after anonymity and two years after the results are published.
When the data will become available and for how long
two years after the results are published
To whom data/document is available
Physicians and specialists in the field of physical medicine and rehabilitation
Under which criteria data/document could be used
Comparison of existing methods with new methods or drugs
From where data/document is obtainable
Email Haghighatshila@gmail.com and obtain permission from Isfahan University of Medical Sciences.
What processes are involved for a request to access data/document
Send request by email to Haghighatshila@gmail.com and obtain permission from Isfahan University of Medical Sciences.
Comments
Loading...