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Comparative evaluation of conservative treatment effects on humeral lateral epicondylitis

Protocol summary

Summary
Objectives: Comparative evaluation of using tennis elbow strap and physical therapy in conservative treatment of lateral humeral epicondylitis. Design: In this single blinded clinical trial 30 patients with lateral humeral epicondylitis will participate. Patients will be randomly assigned to one of the two treatment or control groups. The present study will be conducted in two patient recruiting centers at two phases with 2 weeks interval. Setting and conduct: The amount of pain, functional ability, grip force, pain threshold, and elbow range of motion will be evaluated by visual analog scale, PRTEE questionnaire, dynamometer, algometer, and goniometer, respectively. Two weeks after physical therapy or physical therapy with fastening tennis elbow strap, the amount of these variables will be evaluated again. Participants: Using judgmental non probability sampling method, those patients who met main inclusion criteria of age range between 35-50 years, lateral epicondyle pain history more than 6 weeks and lesser than 6 months,and no use of pain killer medications will be selected. Moreover, the main exclusion criteria are elbow joint movement limitation and bilateral lateral epicondylitis. Intervention: In intervention group tennis elbow strap will be used besides to physical therapy while in the control group just physical therapy will be used. Main outcome measures: Pain, functional ability, grip force, pain threshold, and elbow range of motion

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015110224596N2
Registration date: 2015-12-12, 1394/09/21
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-12-12, 1394/09/21
Registrant information
Name
Kamiar Ghoseiri
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1571
Email address
k.ghoseiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of the Hamadan University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of conservative treatment effects on humeral lateral epicondylitis
Public title
Treatment of Tennis Elbow
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion Criteria:Age range from 35 - 50 years; Existence of tennis elbow and pain in lateral epicondyle of the humerus based on Moudsley and Mills tests during clinical examination by specialty physician; Existence of pain at lateral epicondyle for more than 6 weeks and less than 6 months; Signing the consent form to agree participating in study; No use of pain killer medications and Corticosteroid injection Exclusion Criteria: Limited elbow joint range of motion based on clinical examination; Bilateral tennis elbow; Neck and shoulder pain referrals; No ability to filling out questionnaires; Any fracture or history of surgery at arm and forearm; Any type of arthritis in upper extremities
Age
From 35 years old to 50 years old
Gender
Both
Phase
1
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
Randomization will be done by selecting a paper piece that contain a type of treatment.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Mahdiyeh Ave, In front of Mellat park
City
Hamadan
Postal code
Approval date
2015-10-31, 1394/08/09
Ethics committee reference number
IR.UMSHA.REC.1394.349

Health conditions studied

1

Description of health condition studied
Lateral Epicondylitis
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis

Primary outcomes

1

Description
Pain
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Visual Analog Scale

2

Description
Function
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
PRTEE Questionnaire

3

Description
Grip Force
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Jamar Dynamometer

4

Description
Pain Threshold of lateral Epicondyle
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Algometer

5

Description
Elbow range of Motion
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Electrical Goniometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 14 sessions of physical therapy by manipulation, muscle stretching, muscle strengthening, and ultrasound with using prefabricated neoprene Tennis Elbow Strap for two weeks
Category
Treatment - Other

2

Description
Control group: 14 sessions of physical therapy by manipulation, muscle stretching, muscle strengthening, and ultrasound
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Kamiar Ghoseiri
Street address
Shahid Beheshti Blvd, Besat Hospital
City
Hamadan

2

Recruitment center
Name of recruitment center
Shahid Mobasher Kashani Hospital
Full name of responsible person
Kamiar Ghoseiri
Street address
Mahdiyeh Ave, Shahid Mobasher Kashani Hospital
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of the Hamadan University of Medical Sciences
Full name of responsible person
Dr. Bashirian
Street address
Mahdiyeh Ave, In front of Mellat Park
City
Hamadan
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 the Hamadan University of Medical Sciences
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
Hamadan University of Medical Sciences
Full name of responsible person
Kamiar Ghoseiri
Position
Assistant Professor
Other areas of specialty/work
Street address
Mahdiyeh Ave, In front of Mellat Park
City
Hamadan
Postal code
Phone
+98 81 3838 1571
Fax
Email
k.ghoseiri@umsha.ac.ir; kamiar_g@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Kamiar Ghoseiri
Position
Assistant Professor
Other areas of specialty/work
Street address
Mahdiyeh Ave, In front of Mellat Park
City
Hamadan
Postal code
Phone
+98 81 3838 1571
Fax
Email
K.ghoseiri@umsha.ac.ir; kamiar_g@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Kamiar Ghoseiri
Position
Assistant Professor
Other areas of specialty/work
Street address
Mahdiyeh Ave, In front of Mellat Park
City
Hamadan
Postal code
Phone
+98 81383811571
Fax
Email
K.ghoseiri@umsha.ac.ir; kamiar_g@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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