The immediate effects of counterforce brace with and without vibration on pain, range of motion, grip strength and wrist extensor muscles strength in participant with tennis elbow
Evaluation of the immediate effect of the counterforce brace with and without vibration on pain, range of motion, grip strength and wrist extensor muscles strength in tennis elbow. Comparison of the immediate effect of the counterforce brace with and without vibration on pain, range of motion, grip strength and wrist extensor muscles strength in tennis elbow.
Design
Interventional study, without control group and blinding
Settings and conduct
The variables are measured before the intervention. The patients are given counterforce and after the brace is closed on the site and the patient is comfortable, the variables are measured. The brace is removed ( to eliminate its impact by a 5-minute interval that is approximately 15 minutes to ensure this time) and the brace with vibration are positioned at the desired location and the variables are measured again. Because of the probability of the vibration effect remaining, all patients will first be treated with a conventional counterforce and a second brace with vibration.
Participants/Inclusion and exclusion criteria
Inclusion criteria: people with tennis elbows; age between 20 to 60 years old; no history of surgery, cervical disc, elbow fracture; without rheumatic diseases and peripheral neuropathy.
Intervention groups
Intervention group I: counterforse brace without vibration that closes 2.5 cm below the elbow. Intervention group II: counterforse brace with vibration with frequency of 30 to 50 Hz, 2.5 mm amplitude and intensity tolerable for the patient that closes 2.5 cm below the elbow.
Main outcome variables
Pain; grip strength; range of motion; wrist extensor muscles strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180619040148N3
Registration date:2020-01-13, 1398/10/23
Registration timing:registered_while_recruiting
Last update:2020-01-13, 1398/10/23
Update count:0
Registration date
2020-01-13, 1398/10/23
Registrant information
Name
Masumeh Bagherzadeh Cham
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1612
Email address
bagherzadehcham.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The immediate effects of counterforce brace with and without vibration on pain, range of motion, grip strength and wrist extensor muscles strength in participant with tennis elbow
Public title
The immediate effects of counterforce brace with and without vibration in participant with tennis elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with tennis elbows according to the diagnosis of a specialist physician and standard diagnostic criteria
Age 20 to 60 years old
Exclusion criteria:
History of surgery, cervical disc and elbow fracture
Rheumatic diseases and peripheral neuropathy
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
27
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
Measurement of pain before intervention, after the first intervention and after the second intervention
Method of measurement
Visual analog scale and algometer for measuring pain
2
Description
Range of motion
Timepoint
Measurement of range of motion before intervention, after the first intervention and after the second intervention
Method of measurement
Goniometer for measuring range of motion
3
Description
Grip strength
Timepoint
Measurement of grip strength before intervention, after the first intervention and after the second intervention
Method of measurement
Dynamometer to measure grip strength
4
Description
Wrist extensor muscles strength
Timepoint
Measurement of strength of wrist extensor muscles before intervention, after the first intervention and after the second intervention
Method of measurement
Digital dynamometer for measuring the strength of wrist extensor muscles
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Brace counterforses, 5 minutes on the patient's hand, Location: 2.5 cm below the elbow. Intervention group II: Counterfeit brace with vibration, frequency 30-50 Hz, 2.5 mm amplitude, patient tolerance intensity for 5 minutes, location: 2.5 cm below elbow
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Masumeh Bagherzadeh Cham
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and Prosthetics
Street address
Neuro Masculo Skeletal research center., Firozgar Haspital., Valiasr Sq., Karimkhan St., Behafarin St
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1612
Fax
Email
BagherzadehCham.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masumeh Bagherzadeh Cham
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Neuro Masculo Skeletal research center., Firozgar Haspital., Valiasr Sq., Karimkhan St., Behafarin St
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1612
Fax
Email
BagherzadehCham.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masumeh Bagherzadeh Cham
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Neuro Masculo Skeletal research center., Firozgar Haspital., Valiasr Sq., Karimkhan St., Behafarin St
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1612
Fax
Email
BagherzadehCham.m@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
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
Title and more details about the data/document
All data can be shared after unidentifiable people
When the data will become available and for how long
Starting one year after article publication
To whom data/document is available
Information is available to all researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use of data is only possible by mentioning the name and organizational affiliation of the correspond and co-author of the project and the published article.
From where data/document is obtainable
Connect to Dr Masumeh Bagherzadeh Cham by email: masumehbagherzadeh@gmail.com
What processes are involved for a request to access data/document
If information is used in scientific and therapeutic activities, information is provided as soon as possible.