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Evaluation of the effect of focus shockwave and radial shockwave on the improvement of clinical symptoms and function in patients with carpal tunnel syndrome

Protocol summary

Study aim
Determination and comparison of radial shockwave methods in comparison with focus shock shockwave in improving clinical symptoms and function of patients with carpal tunnel syndrome
Design
The clinical trial, with parallel groups, single-blind, randomized, phase 2 on 40 patients
Settings and conduct
In this randomized Single-blind clinical trial study, 40 patients with carpal tunnel syndrome referred to Al-Zahra Hospital in Isfahan will be included in the study and randomly divided into two groups. One group is exposed to radial shockwave and the other group is exposed to focus shockwave. It is necessary to mention that the patient and the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention. Then the disease severity score, functional status, and pain of patients will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria included age over 18 years, carpal tunnel syndrome with mild to moderate severity, complete all treatment sessions, and consent to participate in the study. Exclusion criteria included severe carpal tunnel syndrome, having diseases that mimic the symptoms of carpal tunnel syndrome, pregnancy, having diabetes, coagulation disorders, history of wrist fractures and dislocations, opioid use, and taking herbal medicines and complementary medicine.
Intervention groups
Intervention group 1: In this group, sham focus with radial shockwave in the carpal tunnel area is done one session per week for 3 weeks. Second intervention group: In this group, radial sham with focus shockwave in the carpal tunnel area is done one session per week for 3 weeks.
Main outcome variables
Disease severity score; Functional status score; Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N38
Registration date: 2021-08-21, 1400/05/30
Registration timing: prospective

Last update: 2021-08-21, 1400/05/30
Update count: 0
Registration date
2021-08-21, 1400/05/30
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-22, 1400/05/31
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of focus shockwave and radial shockwave on the improvement of clinical symptoms and function in patients with carpal tunnel syndrome
Public title
The effect of two shockwave focus and radial on the recovery of patients with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Carpal tunnel syndrome with mild to moderate severity approved by a physician based on clinical examination and standard electrodiagnostic criteria Complete all treatment sessions (once a week for up to three weeks) consent to participate in the study
Exclusion criteria:
Severe carpal tunnel syndrome (Severe) Having diseases that mimic the symptoms of carpal tunnel syndrome, such as cervical radiculopathy, peripheral neuropathy, and median nerve trauma Pregnancy Having diabetes History of wrist fractures and dislocations History of hand surgery in the last 6 months Warfarin use or hereditary or acquired coagulation disorders Opioid use Taking herbal medicines and complementary medicine
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 40 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into two parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the different shockwave in this study, the researcher is aware of the type of intervention in each group. However, the patient and the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention.
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
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-11-13, 1399/08/23
Ethics committee reference number
IR.MUI.MED.REC.1399.712

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
Disease severity score
Timepoint
Before the intervention, three weeks and three months after the intervention
Method of measurement
The Boston Carpal Tunnel Questionnaire (BCTQ)

Secondary outcomes

1

Description
Functional status score
Timepoint
Before the intervention, three weeks and three months after the intervention
Method of measurement
The Boston Carpal Tunnel Questionnaire (BCTQ)

2

Description
Pain
Timepoint
Before the intervention, three weeks and three months after the intervention
Method of measurement
The Boston Carpal Tunnel Questionnaire (BCTQ)

Intervention groups

1

Description
Intervention group 1: In this group, sham focus with radial shockwave (3000 shocks, intensity 3 bar and frequency HZ 10) in the carpal tunnel area is done one session per week for 3 weeks.
Category
Treatment - Other

2

Description
Second intervention group: In this group, radial sham with shockwave focus (3000 shocks, intensity 1 J/cm2 and frequency 3 HZ) in the carpal tunnel area is done one session per week for 3 weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Babak Vahdatpour
Street address
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
vahdatpour@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences and Health Services, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
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?
No
Title of funding source
Isfahan 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
Babak Vahdatpour
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
vahdatpour@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Vahdatpour
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
vahdatpour@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Modina Sadat Javadi
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Modina.javadi@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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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