this study was aimed to evaluate the effectiveness of topical GTN in the treatment of patients with Tennis elbow
Design
Clinical trials with control group, tennis elbow, with parallel groups, blind, randomized
Settings and conduct
In this double-blind clinical trial, a total of 84 patients with Tennis Elbow who referred to orthopedic and rheumatology clinics of Bou-Ali Hospital in the control and control groups were 45 and 39, respectively. These patients were included in the study, which was presented to patients with skin patches containing glyceryl nitrate or liquid paraffin (placebo) at the start of the study and recommended that patients receive 20 drops per day at the place where the most tenderness The elbows are localized and can be used on patches for 12 hours during the day. In this study, 4 groups of patients, clinical caregivers, outcome evaluators, and data analyzers were kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients over 16 years of age;Patients who have had symptoms for less than 3 months.
Exclusion criteria:
Patients with heart disease who have a history of using TNG;People with a history of fracture or dislocation of the joint of the elbow, or a wrist or ligament on these joints;People who have had a history of corticosteroid injections in the last three months;People with distal neurological signs to the elbow.
People with seronegative enteropathy
Intervention groups
At the start of the study, patients with dermatological patches and drop containing GTN or liquid paraffin were delivered and patients receive 20 drops daily in the place where the elbow tends to have the highest tendency, and during the period Use patches 12 hours a day, then change the patches the next day and repeat the procedure according to the instructions.
Main outcome variables
Tenderness; Pain severity
General information
Reason for update
Acronym
GTN
IRCT registration information
IRCT registration number:IRCT20180421039375N3
Registration date:2018-12-12, 1397/09/21
Registration timing:retrospective
Last update:2018-12-12, 1397/09/21
Update count:0
Registration date
2018-12-12, 1397/09/21
Registrant information
Name
Hamid Zaferani Arani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7762 3480
Email address
hamid_zaferani@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2012-10-01, 1391/07/10
Expected recruitment end date
2014-01-10, 1392/10/20
Actual recruitment start date
2012-10-02, 1391/07/11
Actual recruitment end date
2014-01-05, 1392/10/15
Trial completion date
2014-01-05, 1392/10/15
Scientific title
A comparative study of Gliseryl trinitrate (GTN) in the treatment of localized Tennis elbow
Public title
Effect of Gliseryl trinitrate (GTN) in the treatment of localized Tennis elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 16 years of age with Tennis Elbow
Patients who have symptoms for less than 3 months
Exclusion criteria:
Patients with heart disease who have a history of TNG use
People with a history of fracture or dislocation of the joint of the elbow, or a wrist or ligament on these joints
People who have had a history of corticosteroid injection over the past three months
People who have distal neuronal symptoms to the elbow
People with Seronegative enteropathy
Age
From 16 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
84
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 84 patients with TE were selected from among the patients referred to the orthopedic and rheumatology clinics of Bou Ali Hospital in a randomized way. They were divided into two groups of case and control. In order to collect the data, eligible patients referred to orthopedic and rheumatology clinics of Bou-Ali Hospital who were willing to participate in the study were randomizedly and blinded by the secretary to two groups receiving drop containing glyceryl nitrate (in the treatment group ) And liquid paraffin (placebo in the control group). As these medications were given in two packages (package A, package B) and divided into 2 groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, four groups of Participant, Care provider, Outcome assessor, and data analysers were kept blind. None of these names knew which dishes contained contained drop glyceryl nitrate or liquid paraffin.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Islamic Azad University of Medical Sciences, Tehran, Iran
Street address
Tehran Medical Branch, Islamic Azad University, Khaghani st, Shari'ati Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19395/1495
Approval date
2012-10-13, 1391/07/22
Ethics committee reference number
13610101912015
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 and tenderness in patients with tennis elbow
Timepoint
Before the intervention and week 2, 4, 6 after intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Quality of life Score
Timepoint
Before the start of the study and 2 months after the start of the study
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Glyceryl nitrate recipient group: Delivered to patients with patches of skin and drop containing glyceryl nitrate, and it is recommended that patients receive 20 drop drops per day in the place where the elbow has the highest tenderness, and within 12 hours in Use patches throughout the day in a position, then change the patches the next day and repeat the procedure according to the instructions. Patients were advised to use a wound extensor tendon rehabilitation program that includes 2 seconds of contraction, 10 seconds of rest and 10 seconds of elongation of the muscles for at least 3 treatments per day. Patient follow-up was performed 2, 4, and 6 weeks after the first visit in subsequent visits, and patients were assessed for pain during nocturnal rest and during daily activities, Mandsley test (presence or absence of pain during resistance to Doris flextion of the wrists and pronation of the forearm), epicondylar tenderness in the first visit and pain and tenderness of epicondylar in subsequent visits were evaluated and the relevant results were recorded in the questionnaires.
Category
Treatment - Drugs
2
Description
Control group: The placebo recipient group: Delivered to patients with patches of skin and drop containing liquid paraffin, and it is recommended that patients receive 20 drop drops per day in the place where the elbow has the highest tenderness, and within 12 hours in Use patches throughout the day in a position, then change the patches the next day and repeat the procedure according to the instructions. Patients were advised to use a wound extensor tendon rehabilitation program that includes 2 seconds of contraction, 10 seconds of rest and 10 seconds of elongation of the muscles for at least 3 treatments per day. Patient follow-up was performed 2, 4, and 6 weeks after the first visit in subsequent visits, and patients were assessed for pain during nocturnal rest and during daily activities, Mandsley test (presence or absence of pain during resistance to Doris flextion of the wrists and pronation of the forearm), epicondylar tenderness in the first visit and pain and tenderness of epicondylar in subsequent visits were evaluated and the relevant results were recorded in the questionnaires.