Protocol summary

Summary
The purpose of this study is to investigation of the effect of dry needling on radiated pain of shoulder muscles trigger points in tennis elbow patients. In the present study 14 females aged 20-45 years with trigger points in mentioned muscles are selected through convenience sampling and then are assigned to control and intervention groups randomly. Treatments in control group include ultrasound, electrotherapy, icepack and exercise therapy. Dry needling on trigger points will be applied for the patients in intervention group on alternate session (maximum 6 sessions) in addition to the treatment in control group. The course of treatment will be 10 sessions in both groups. Pain intensity, pressure sensitivity threshold and grip power will be recorded at the first session before starting the treatment and at the end after 10 sessions by Visual analog scale (VAS), Algometry and Dynamometry in each group. Finally by comparison these variables the effect of dry needling on reduction of elbow pain in patients with tennis elbow will be investigated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201508291552N5
Registration date: 2015-09-11, 1394/06/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-09-11, 1394/06/20
Registrant information
Name
Maryam Ebrahimian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
ebrahimian@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for reasearch of Shiraz University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dry needling on radiated pain of shoulder muscles trigger points in tennis elbow patients.
Public title
Effect of dry needling on radiated pain of shoulder muscles trigger points in tennis elbow patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women with tennis elbow and trigger points in the supraspinatus, infraspinatus, sub scapularis and scalene muscles age range 20-45 years Exclusion criteria:History of injury to the ribs, thoracic and cervical spine, history of fracture , dislocation , trauma and surgery of the upper limb, cardiovascular disease , depression and severe anxiety, neurological signs and symptoms , rheumatic diseases , infectious diseases.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 14
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

1

Registry name
ثبت نگردیده است
Secondary trial Id
ندارد
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
In front of Felestin Street, Zand Avenue
City
Shiraz
Postal code
1433671348
Approval date
2015-08-02, 1394/05/11
Ethics committee reference number
IR.SUMS.REC.1394.84

Health conditions studied

1

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

Primary outcomes

1

Description
Pain intensity
Timepoint
Before and after intervention
Method of measurement
Visual Analog Scale(VAS)

Secondary outcomes

1

Description
Grip strength
Timepoint
Before and after intervention
Method of measurement
Dynamometry

2

Description
Pressure sensitivity threshold
Timepoint
Before and after intervention
Method of measurement
Algometry

Intervention groups

1

Description
In the intervention group:5 minutes continues ultrasound , 20 minutes burst TENS with ice pack, exercise therapy (3times a day each time 3 sets 15 times), Dry needle (maximum 6 sessions )
Category
Rehabilitation

2

Description
In the control group: 5 minutes continues ultrasound , 20 minutes burst TENS with ice pack, exercise therapy (3times a day each time 3 sets 15 times)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation Sciences School of Shiraz University of Medical Sciences
Full name of responsible person
Maryam Ebrahimian
Street address
Abiverdi No.1 St., Shahid Chamran Blvd.
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Affirs of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Sayed Basir Hashemi
Street address
7th fioor of Central Building of Shiraz University of Medi cal Sciences,In front of Felestin Street, Zand Avenue.
City
Shiraz
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 Affirs of Shiraz 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
Rehabilitation Sciences School of Shiraz University of Medical Sciences
Full name of responsible person
Maryam Ebrahimian
Position
Master of Science/ Faculty member
Other areas of specialty/work
Street address
Rehabilitation Sciences School, Abiverdi No.1 St., Shahid Chamran Blvd.
City
Shiraz
Postal code
7194733669
Phone
+98 71 3627 1552
Fax
+98 71 3627 2495
Email
ebrahimian@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rehablitation Sciences School of Shiraz Univercity of Medical Sciences
Full name of responsible person
Maryam Ebrahimian
Position
Master of science/ Faculty member
Other areas of specialty/work
Street address
Rehabilitation Sciences school, Abiverdi No.1, Shahid Chamran Blvd
City
Shiraz
Postal code
7194733669
Phone
+98 71 3627 1552
Fax
+98 71 3627 2495
Email
ebrahimian@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rehabilitation Sciences School of Shiraz University of Medical Sciences
Full name of responsible person
Maryam Ebrahimian
Position
Master of Science/ Faculty member
Other areas of specialty/work
Street address
Rehabilitation Sciences School, Abiverdi No.1 St.,Shahid Chamran Blvd
City
Shiraz
Postal code
7194733669
Phone
+98 71 3627 1552
Fax
+98 71 3627 2495
Email
ebrahimian@sums.ac.ir
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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