Protocol summary

Study aim
Efficacy of extracorporeal shock wave in the treatment of lateral epicondylitis in athletes using ultrasonography
Design
A randomized, double-blind randomized clinical trial with a sham group with a sample size of 25 patients.
Settings and conduct
Study Location: Sports Medicine Federation Step 1: Clinical examination Step 2: Complete the informed consent form Step 3: Complete the questionnaire including personal details Step 4: Perform ultrasonography Step 5: Complete the Visual Analogue Scale and Disabilities of the Arm, Shoulder, and Hand Questionnaire, strength hand grip Measurement Step 6: Implementation of the treatment.Two groups studied (exprimental, sham),double blind study (the evaluator and the investigator are not aware and only the operator knows the status of the groups). Step 7: Assess the effect of treatment.
Participants/Inclusion and exclusion criteria
inclusion criteria: Confirmation of lateral epicondylitis, at least 3 months of pain in the area, treatment of the affected area for up to 3 months,visual analogue Scale greater than 4. exclusion criteria: Age less than 18 years old, Contraindication of shock wave, history of lateral epicondial surgery, elbow deformity, cervical radiculopathy , History of rheumatologic diseases, history of shock wave treatment in 12 months Past or injection in the last 3 months.
Intervention groups
An experimental group: a 4 Hz frequency shock wave, an energy flux density of 0.08 j/mm ², 2000 Shock, once a week for 3 weeks The Sham group: a 4 Hz frequency shock wave, and energy flux density of 0.04 J /mm ², 1500 Shock, once a week for 3 weeks with foam in the area. Physical therapy is then performed with stretching exercise, 3 times a day and 4-5 repetitions.
Main outcome variables
Visual Analogue Scale Score, Disabilities of the Arm, Shoulder, and Hand Questionnaire Score, strength hand grip score, Check the thickness of the muscle.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190626044015N1
Registration date: 2019-08-04, 1398/05/13
Registration timing: prospective

Last update: 2019-08-04, 1398/05/13
Update count: 0
Registration date
2019-08-04, 1398/05/13
Registrant information
Name
Khadijeh Hosseinzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2211 6998
Email address
m.hosseinzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of extracorporeal shock wave therapy in the treatment of lateral epicondylitis in athletes using ultrasonography
Public title
Efficacy of shock wave therapy in the treatment of tennis elbow in athletes using sonography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed lateral epicondylitis At least 3 month of pain on lateral epicondyle Treatment to the affected area within the previous 3 month VAS above 4 Age between 2 and 4 years
Exclusion criteria:
< 18 year of age Contraindications for shockwave therapy ( malignancy, history of infected area involved, epilepsy, epilepsy, use of pacemaker, pregnancy) History of lateral epicondylitis surgery Elbow deformity Cervical radiculopathy History of rheumatology or polyarthritis The history of vasculitis The history of treatment with Shakviou in the last 12 months History of injection in the last 3 months (Corticosteroid, Autologous blood injection, PRP, Mesotherapy) Congenital or acquired deformities of the upper extremity
Age
From 18 years old to 36 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 25
More than 1 sample in each individual
Number of samples in each individual: 2
Given that lateral epicondylitis can be one-way or two-sided, if there is an Inclusion and Exclusion Criteriaon both elbows (for example, if the elbow has injected a side of less than 3 months, then this position does not participate in the research) One person can have two samples.
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by lottery means that at the beginning of the study and in the first referring patient, the group names are written in 2 pieces of paper and placed in one of two intervention or control groups by the patient operator's removal. By identifying the first patient's treatment group, the next patient will be assigned to the other group and thus the patients will be divided into groups. In this study, the researcher, evaluator, and participants are unaware of the study group allocation and only the operator is aware of the group assignment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants enter the research after completing the informed consent form and are divided into two groups. From this stage, only the operator of the device has been informed from the medical group and the participants, the resarcher and the evaluator to avoid the bias in the study from the subjects of the study groups No information is available.
Placebo
Used
Assignment
Parallel
Other design features
Examples include athletes who are brought to the attention of sports federations, who will begin treatment with the approval of the center.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shiraz university of medical science
Street address
No. 10, Payvand 21., Payam Blvd., Paknejad Bvd., Saadatabad
City
Tehran
Province
Tehran
Postal code
۱۹۸۱۹۴۴۴۱۵
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.SEMUMS.REC.1398.002

Health conditions studied

1

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

Primary outcomes

1

Description
Measurement of tendon thickness
Timepoint
Before the intervention begins and one month after the end of the intervention
Method of measurement
Ultrasonography

Secondary outcomes

1

Description
Pain score
Timepoint
At the beginning of the study (before the intervention), after the end of the intervention and one month after the end of the intervention
Method of measurement
Visual Analogue Scale

2

Description
Performance score
Timepoint
Before the intervention begins, after the intervention and one month after the end of the intervention
Method of measurement
Disabilities of the Arm, Shoulder, and Hand Questionnaire

3

Description
hand strength score
Timepoint
Before the intervention begins, after the intervention and one month after the end of the intervention
Method of measurement
Dynamometer

Intervention groups

1

Description
Intervention group: a 4 Hz frequency shock wave, an energy flux density of 0.08 j/mm ², 2000 Shock, once a week for 3 weeks. Physical therapy is then performed with stretching exercise, 3 times a day and 4-5 repetitions. Shock wave unit: ESM /SWISS DOLORCLAST/ Switzerland
Category
Rehabilitation

2

Description
Control group: Sham group, a 4 Hz frequency shock wave, an energy flux density of 0.04 j/mm ², 1500 shocks, once a week and for 3 weeks with foam mediator in the area. Also physiotherapy with stretching exercises for 3 times Performs 4-5 repetitions per day.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Sports Medicine Federation
Full name of responsible person
Dr. GholamReza Norouzi
Street address
Sports Medicine Federation, Varzandeh Ave, South Mofateh Ave, 7 Tir
City
Tehran
Province
Tehran
Postal code
1571745613
Phone
+98 21 83826
Email
ifsm.info@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminianfar
Street address
School of rehabilitation, Semnan University of Medical Sciences, 5 km of Semnan-Damghan road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
aminfar@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminianfar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of rehabilitation, Semnan University of Medical Sciences, 5 km of Semnan-Damghan road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
aminfar@semums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminianfar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of rehabilitation, Semnan University of Medical Sciences, 5 km of Semnan-Damghan road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
aminfar@semums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminianfar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of rehabilitation, Semnan University of Medical Sciences, 5 km of Semnan-Damghan road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
aminfar@semums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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