Determining the effect of dextrose prolotherapy vs steroid in improvement of patients with chronic lateral epicondylitis
Design
In this study 36 patients with chronic lateral epicondylitis having inclusion criteria reffered to Mahdieh and Shahid modarres hospital have been chosen and randomly put in injection groups :dextrose prolotherapy or steroid with a given code
Settings and conduct
All patients with chronic lateral epicondylitis refering to mahdieh and shahid modarres hospital
Patients and Assessor are blind to the type of injection
Participants/Inclusion and exclusion criteria
All patient with chronic lateral epicondylitis by these inclusion criteria: 1- age range of 18 to 55 2- Positive Cozen test 3- No response to the conservative treatment are included to the study and patients with these exclusion criteria:1- Rheumatologic disease 2- Diabetes melitus 3- Pregnancy4- Cuagulopathy 5-History of trauma and 6- C6,C7 radiculopathy will be excluded.
Intervention groups
Steroid injection: control group;
Dextrose prolotherapy: intervention group
Main outcome variables
The pain intensity by VAS,
The physical function and symptoms by quick DASH score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170311033000N3
Registration date:2018-02-17, 1396/11/28
Registration timing:registered_while_recruiting
Last update:2018-02-17, 1396/11/28
Update count:0
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Masume Bayat
Name of organization / entity
Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
bayat.masyme@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-22, 1396/05/31
Expected recruitment end date
2018-12-20, 1397/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of steroid injection vs dextrose prolotherapy effects in improvement of patients with chronic lateral epicondylitis
Public title
Comparison of steroid injection vs dextrose prolotherapy in patients with chronic lateral epicondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patient having lateral epicondylitis for atleast 3 months
All patients having chronic lateral epicondylitis with age range 18 -55 years old
All patients having chronic lateral epicondylitis with Cozen positive test
All patients having lateral epicondylitis didnt answer to conservative treatment
Exclusion criteria:
Any kind of injection about the involved elbow during previous 3months
C6,C7 radiculopathy in the involved upper limb
Cuagulopathy or using anti cuagulants
diabetes melitus
pregnancy
surgery about the involved elbow during previous 3 months
Rhumatologic disorder
Recent trauma to the involved elbow since 3months ago
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients as participants and the responsible physician as an assessor of the out comes are blinded to the type of injection
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Ethics committe,Shahid Beheshti University of Medical Sciences, Velenjak street, Teheran, Iran
City
Teheran
Province
Tehran
Postal code
1985717443
Approval date
2017-12-24, 1396/10/03
Ethics committee reference number
IR.SBMU.MSP.REC.1396.646
Health conditions studied
1
Description of health condition studied
chronic lateral epicondylitis
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis
Primary outcomes
1
Description
The pain intensity
Timepoint
Before injection , 1month and 3 months after the injection
Method of measurement
Asking patients to rate his/her pain in range of 0 -10 based on visual analogue scale
2
Description
The patient's function score
Timepoint
Before injection , 1month and 3 months after the injection
Method of measurement
Based on Quick DASH questionarie
3
Description
The patient's symptoms score
Timepoint
Before injection , 1month and 3 months after the injection
Method of measurement
Based on Quick DASH questionarie
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One time injection of 2cc dextrose 16 % made from 4 cc dextrose 20% and 1 cc lidocaine 2% with blue needle by pepering technique in lateral epicondyle region
Category
Treatment - Other
2
Description
Control group: One time injection of solution 1 cc methylprednisolone 40 mg and 1 cc lidocaine with blue needle by pepering technique in lateral epicondyle region