Objective:to detemine the suitable method of treatment in patients with tennis elbow to improve pain and function.type of study:randommized,single blinde,study population: age between 18-64 years old؛at least 3months pain in lateral epicondyle؛failure of at least one common treatment of tennis elbow؛pain and tenderness in lateral epicondyl؛tenderness in origin of extensor carpi radialis brevis muscle in 5-10mm distal to lateral epicondyl؛pain score in visual analogue scale greater than 4.
Exclusion criteria:injection of corticosteroid in previous 6 weeks ؛ previous dextrose injection؛neck pain؛coagulopathies or anticoalants intake؛pregnancy؛concomitant pathology or previous surgery of upper limbs؛chronic use of opioids؛physiotherapy in previous 8 weeks؛diabetes؛rheumatologic disorders؛history of arthritis؛fibromyalgia
This study sample size is 30 patients who divide randomly in two groups:one with dextrose 20% injection and another with shock wave.in prolotherapy group(dextrose 20%) the patiens are injected one time and follow 1 and 2 months after injection.in shock wave group patiens have 3 shock wave therapy sessions weekly and then follow 1 and 2 month after 1st session.the patients assessment is done with Visual Analogue Scale (VAS),DASH questionnaire, gripe strength with dynamometer and pressure pain threshold with Algometer .
General information
Acronym
ESWT-Extracorporeal shock wave therapy
IRCT registration information
IRCT registration number:IRCT2014081718831N1
Registration date:2014-09-29, 1393/07/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-29, 1393/07/07
Registrant information
Name
Maryam Esmaeili jamkarani
Name of organization / entity
Firuzgar hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1600
Email address
mej3272@yahoo.com
Recruitment status
Recruitment complete
Funding source
Department of physical medicine and rehabilitation, Firoozgar hospital, Iran University of Medical Science.
Expected recruitment start date
2014-09-16, 1393/06/25
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare injection of dextrose20% and extracorporeal shock wave therapy in treatment of tennis elbow.
Public title
Comparison between injection of dexrose20% and shock wave therapy in treatment of elbow pain(tennis elbow)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:age between 18-64 years old؛at least 3months pain in lateral epicondyle؛failure of at least one common treatment of tennis elbow؛pain and tenderness in lateral epicondyl؛tenderness in origin of extensor carpi radialis brevis muscle in 5-10mm distal to lateral epicondyl؛pain score in visual analogue scale greater than 4.
Exclusion criteria:injection of corticosteroid in previous 6 weeks ؛ previous dextrose injection؛neck pain؛coagulopathies or anticoalants intake؛pregnancy؛concomitant pathology or previous surgery of upper limbs؛chronic use of opioids؛physiotherapy in previous 8 weeks؛diabetes؛rheumatologic disorders؛history of arthritis؛fibromyalgia
Age
From 18 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciance
Street address
Iran University of Medical Sciance, Hemmat high way, Tehran
City
Tehran
Postal code
Approval date
2014-09-14, 1393/06/23
Ethics committee reference number
93/د/2889/105
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 score
Timepoint
Before intervention,one month after intervention.two months after intervention
Method of measurement
Visual analogue sacle(VAS)
2
Description
The ability of patient to do daily works that need hands to doing them.
Timepoint
before intervention,one month after intervention.two month after intervention
Method of measurement
Quick DASH questionnair
3
Description
Gripp strength
Timepoint
Before intervention,one month after intervention,two months after intervention
Method of measurement
By use of Dynamometer
4
Description
Pressure pain threshold
Timepoint
Before intervention,one month after intervention,two months after intervention
Method of measurement
By use of Algometer
Secondary outcomes
empty
Intervention groups
1
Description
One Injection of Dexrose 20%,3cc with 1cc of lidocain2% in lateral epicondyle of elbow.
Category
Treatment - Other
2
Description
Three session weekly of extracorporeal shock wave therapy in 2Bar and2000pulses in lateral epicondyle of elbow
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitation department of Firoozgar Hospital
Full name of responsible person
Maryam Esmaili Jamkarani
Street address
Physical Medicine and Rehabilitation department of Firoozgar Hospital, Behafarin Ave, Vli asr Sq, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physical Medicine and Rehabilitation department of Firoozgar Hospital
Full name of responsible person
Bijan Forough MD,manager of Physical Medicine and Rehabilitation department of Firoozgar Hospital
Street address
Physical Medicine and Rehabilitation department, Firoozgar Hospital , Behafarin Ave,Valiasr Sq,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicine and Rehabilitation department of Firoozgar Hospital
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
Physical Medicine and Rehabilitation, Firoozgar Hospital
Full name of responsible person
Maryam Esmaili Jamkarani
Position
Physical Medicine and Rehabilitation assistant
Other areas of specialty/work
Street address
Firoozgar Hospital,Behafarin St, Vali asr Sq, Tehran
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
+98 218894266
Email
Mej3272@yahoo.com
Web page address
Firoozgar.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Tannaz Ahadi
Position
Assistant professor
Other areas of specialty/work
Street address
Iran University of Medical Science, Hemmat highway, beside Milad tower,Tehran
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
+98 218894266
Email
Tannaz.ahadi@yahoo.come
Web page address
Firoozgar.org
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Maryam Esmaili Jamkarani
Position
Assistant
Other areas of specialty/work
Street address
Iran University of Medical Science, Hemmat highway, beside Milad tower, Tehran
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
+98 218894266
Email
Mej3272@yahoo.com
Web page address
Firoozgar.org
Sharing plan
Deidentified Individual Participant Data Set (IPD)