Protocol summary

Summary
Dry needling is a none invasive and cheap method with the effect of treatment in less time, so it seems to be a better way for treatment of athletes with chronic tennis elbow syndrome to decrease duration and costs of treatment. Type of this study is randomized clinical trial. The inclusion criteria is 44 athletes (age 18-40) with three sessions per week, each session at least six hours of practice or race that diagnosed with tennis elbow syndrome which is lasting more than 3 months. The exclusion criteria is the history of fractures or dislocations in the past year; the history of surgery in the past six months; degenerative changes and untreated infections or tumors in shoulder or elbow and needle phobia. The first group takes physical therapy treatments include ultrasound ( continuous, 1 W, 5 minutes) at origin of extensor muscles of forearm and fingers, friction massage for 5 minutes and strengthening with stretching exercises. The second group takes physical therapy along with dry needling. The duration of treatment is three week, three sessions per week. At the beginning of treatment, second and third week and also at the end of third week athletes should fill out the evaluation form for elbow area and grip strength test will be performed. These steps repeat at the end of fourth week as follow up. It seems both methods of treatments will change the amount of pain, function and grip strength of athletes with but our hypothesis is that using dry needling along with physical therapy will be more effective.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016040827284N1
Registration date: 2016-06-16, 1395/03/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-06-16, 1395/03/27
Registrant information
Name
Zahra Etminan
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 387 4299
Email address
stud127043464@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research of Shiraz University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dry needling in tendons of forearm extensors to examine the amount of force grip, pain and functional ability in athletes with chronic tennis elbow
Public title
The effect of dry needling for chronic tennis elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: athletes diagnosed with tennis elbow syndrome, who have 3 sessions per week, each session at least 6 hours of practice or race, with compliance of symptoms more than 3 months. The athletes should have pain at lateral epicondyle area that increases during or after movements and the diagnostic test is positive too; age of participants should be 18-40. exclusion criteria: history of fracture or dislocation at shoulder or elbow in the past year; the history of surgery in the past 6 months; degenerative changes at elbow or shoulder; untreated infection or tumors at elbow or shoulder; Pressure on the cervical nerve roots; person with radial tunnel syndrome; impingement of nerves at arm and forearm
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz Univercity of Medical Siences
Street address
Zand Ave.
City
Shiraz
Postal code
Approval date
2016-02-17, 1394/11/28
Ethics committee reference number
IR.SUMS.REC.1394.202

Health conditions studied

1

Description of health condition studied
choronic tennis elbow syndrome
ICD-10 code
M65-M68
ICD-10 code description
Disorders of synovium and tendon

Primary outcomes

1

Description
pain
Timepoint
beginning of first,second,third and also at the end of third and forth week
Method of measurement
patient rate elbow evaluation questionnaire

2

Description
function
Timepoint
beginning of first,second,third and also at the end of third and forth week
Method of measurement
patient rate elbow evaluation questionnaire

3

Description
grip strenght
Timepoint
beginning of first,second,third and also at the end of third and forth week
Method of measurement
hand dynamometer

Secondary outcomes

1

Description
none
Timepoint
none
Method of measurement
none

Intervention groups

1

Description
The control group take physical therapy treatments include ultrasound ( continuous, 1 W, 5 minutes) at origine of extensore muscles of forearm and fingers, friction massage for 5 minutes and strengthening and stretching exercises 3 sessions per week foe 3 weeks.
Category
Rehabilitation

2

Description
The intervention group take physical therapy along with dry needling 3 sessions per week for 3 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
sport clubs
Full name of responsible person
Zahra Etminan
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
none
Full name of responsible person
none
Street address
none
City
none
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
none
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
Shiraz University of Rehabilitation Sciences
Full name of responsible person
Zahra Etminan
Position
student
Other areas of specialty/work
Street address
Shiraz University of Rehabilitation Sciences, Abiverdi Ave., Chamran Blved.
City
Shiraz
Postal code
Phone
+98 71 3843 9859
Fax
Email
z.espt92@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Rehabilitation Sciences
Full name of responsible person
Dr. Mohsen Razeghi
Position
Associate Professor
Other areas of specialty/work
Street address
Shiraz University of Rehabilitation Sciences, Abiverdi Ave., Chamran Blved.
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
razeghm@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Rehabilitation Sciences
Full name of responsible person
Zahra Etminan
Position
student
Other areas of specialty/work
Street address
Shiraz University of Rehabilitation Sciences, Abiverdi Ave., Chamran Blved.
City
Shiraz
Postal code
Phone
+98 71 3843 9859
Fax
Email
z.espt92@gmail.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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