Study aims:The efficacy of topical therapy Tennis elbow Glysryl trinitrate compared with placebo in patients with tennis elbow.Inclusion criteria:Tennis Elbow patients; aged over 16 years to less than 3 months before the start of the trial; the symptoms have been involved. Study population: Patients with Tennis Elbow referred to orthopedic and rheumatology Ali Hospital in Tehran. Sample size: 84 patients in the two treatment groups GTN and control (placebo). Intervention under study and its time length: At baseline, dermal patches and TNG drops (treatment group) or liquid paraffin drops (placebo) were given to the patients and they were instructed to drip 20 drops daily on the site with the greatest local pain of the elbow, and cover it with a patch for 12 hours during the day. They also were trained to change the patch and repeat the instructions the next day and both groups were treated for 6 weeks. Primary outcome measure: The patients were evaluated in terms of pain during rest at night and daily activities as well as Maudsley’s test (presence or absence of pain during resistance against bending of wrist extensors and forearm pronation) and in terms of tenderness and pain at epicondyle.
General information
Acronym
TE
IRCT registration information
IRCT registration number:IRCT2015021421075N1
Registration date:2015-07-19, 1394/04/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-19, 1394/04/28
Registrant information
Name
Shahla Abolghasemi
Name of organization / entity
Islamic Azad University Tehran Medical Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 3316 9412
Email address
shabolghasemi@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad University Tehran Medical Branch
Expected recruitment start date
2013-03-22, 1392/01/02
Expected recruitment end date
2014-03-22, 1393/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Topical Trinitrate Glyceryl (TNG) in the Treatment of Tennis Elbow
Public title
A comparative study of Gliseryl trinitrate (GTN) in the treatment of localized Tennis elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Tennis Elbow patients; aged over 16 years to less than 3 months before the start of the trial; the symptoms have been involved.
Exclusion criteria:Patients with heart disease who had a history of GTN; history of fracture or dislocation of the elbow or wrist; or those on the joints had surgery; who had a history of local injection of steroids in the past three months; those with neurological symptoms distal (nerve signals from the reference point) to the elbow; and those who were seronegative patients with enteropathy.
Age
From 16 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University Tehran Medical Branch
Street address
Tehran Medical Branch, Islamic Azad University, khaghani st, shariati Ave, Tehran, Iran
City
Tehran
Postal code
193951495
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
2527
Health conditions studied
1
Description of health condition studied
Tennis Elbow
ICD-10 code
M77.1
ICD-10 code description
Tennis Elbow
Primary outcomes
1
Description
In terms of pain during rest at night and daily activities as well as Maudsley’s test
Timepoint
Before treatment, 2, 4 and 6 weeks after treatment
Method of measurement
Doctor questionnaire and relevant
2
Description
In terms of tenderness at epicondyle
Timepoint
Before treatment, 2, 4 and 6 weeks after treatment
Method of measurement
With doctor visits and questionnaires
3
Description
In terms of pain at epicondyle
Timepoint
Before treatment, 2, 4 and 6 weeks after treatment
Method of measurement
With doctor visits and questionnaires
Secondary outcomes
1
Description
mild to moderate headache
Timepoint
Every six hours
Method of measurement
Diagnosis of the patient's pain
Intervention groups
1
Description
Treatment group:At baseline, dermal patches and TNG drops were given to the patients and they were instructed to drip 20 drops daily on the site with the greatest local pain of the elbow, and cover it with a patch for 12 hours during the day. They also were trained to change the patch and repeat the instructions the next day. This practice continued for 6 weeks.
Category
Treatment - Drugs
2
Description
Control Group:At baseline, dermal patches and liquid paraffin drops were given to the patients and they were instructed to drip 20 drops daily on the site with the greatest local pain of the elbow, and cover it with a patch for 12 hours during the day. They also were trained to change the patch and repeat the instructions the next day. This practice continued for 6 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali Hospital
Full name of responsible person
Shahla Abolghasemi
Street address
Boali Hospital, Damavand St, Imam Husein Sq., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University Tehran Medical Branch
Full name of responsible person
Majid Naghipour
Street address
Islamic Azad University Tehran Medical branch, Khaghani St., Shariati St.
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, Islamic Azad University Tehran Medical Branch
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
Islamic Azad University Tehran Medical Branch
Full name of responsible person
Dr Shahla Abolghasemi
Position
Department of Rheumatology
Other areas of specialty/work
Street address
Islamic Azad University Tehran Medical branch, Khaghani St., Shariati St.