Objectives: Result of wearing a newly designed tennis elbow strap for tennis elbow disease
Design: New strap with different force vector
Setting and conduct:patients wear this new strap for 48 hours and after 48 hours rest ,they wear traditional strap for 48 hours .we measure pain and grip strength before and after each stage.
Participants: Tennis elbow disease for more than 6 weeks,no history of corticosteroid injection or surgery on the elbow
Intervention: Administration of newly designed brace
main outcome measures:pain ؛ grip strength
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122725722N1
Registration date:2016-03-09, 1394/12/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-09, 1394/12/19
Registrant information
Name
Hosssein Saremi
Name of organization / entity
Hamadan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 8541
Email address
h.saremi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-02-29, 1394/12/10
Expected recruitment end date
2016-09-30, 1395/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing a newly designed tennis elbow orthosis with traditional tennis elbow strap in treatment of patients with lateral epicondylitis
Public title
New brace for tennis elbow disease
Purpose
Treatment
Inclusion/Exclusion criteria
Tennis elbow disease for more than 6 weeks ؛ no injection of corticosteroid؛no surgery on the elbow
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Not randomized
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 commity of university of social welfare and rehabilitation
Street address
No1, Koodakyar st, Daneshjoo blvd, Velenjak, Tehran
City
Tehran
Postal code
Approval date
2014-08-10, 1393/05/19
Ethics committee reference number
IR.uswr.rec.1393.184
Health conditions studied
1
Description of health condition studied
Tennis elbow
ICD-10 code
M77.1
ICD-10 code description
lateral epicondylitis
Primary outcomes
1
Description
Pain
Timepoint
48 hours
Method of measurement
Visual anlage score questionaire
Secondary outcomes
1
Description
Grip strength
Timepoint
48 hours
Method of measurement
Dynamometer jamar
Intervention groups
1
Description
Use of a new brace for 48 hours and traditional brace for the same group after 48 hours rest,for the next 48 hours
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Parsatavanbakhsh orthosis prosthesis center
Full name of responsible person
Vahid Chamani
Street address
No 16,4th floor,Pasargad building, Havapeimai st, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of university of social welfare and rehabilitation
Full name of responsible person
Hamidreza Khankeh
Street address
No1, Koodakyar st, Daneshjoo blvd, Velenjak, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of university of social welfare and rehabilitation
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Socialwelfare and rehabilitationsciences
Full name of responsible person
Vahid Chamani
Position
Master of orthotics and prosthetics
Other areas of specialty/work
Street address
No3, Lali st, Buali ave
City
Hamadan
Postal code
6515696569
Phone
+98 81 3251 5680
Fax
Email
chamani.op@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan university of medical sciences
Full name of responsible person
Hossein Saremi
Position
Assistant professor, orthopaedic surgeon, hand surgery fellowship
Other areas of specialty/work
Street address
No 40, Noor st, Mokhtaran Ave, Saidie bala Blvd,
City
Hamadan
Postal code
Phone
+98 81 3821 8541
Fax
Email
h.saremi@umsha.ac.ir
Web page address
www.shoulderclinic.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
HosssinSaremi
Position
Assistant professor, orthopaedic surgeon,hand surgery fellowship
Other areas of specialty/work
Street address
No40 ,Noor St, Mokhtaran Ave ,Saidie bala Blv
City
Hamadan
Postal code
Phone
+98 81 3821 8541
Fax
Email
h.saremi@umsha.ac.ir
Web page address
www.shoulderclinic.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)