Protocol summary

Study aim
Determination of the effects of dry needling on pain and function of throwing athletes with scapular dyskinesis
Design
Parallel groups, double-blinded, randomized clinical trial
Settings and conduct
After completing the informed consent form and being informed about the research, participants enter the research and randomly assigned to treatment or control groups. they won't be aware of which group they would be in; also assessment and treatment would be done by two therapists
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 to 45 years; doing overhead sports; a positive indication of lateral scapular slide test or scapular dyskinesis test. Exclusion criteria: pain on both sides. recent history of injury to the ribs and cervical vertebrae; recent fracture or dislocation of the upper extremity; dry needling contraindication: using anticoagulant drugs; diabetes; immune system impairments; needle phobia; hypertension; local edema on the shoulder area; local infection or wound on the shoulder area; pregnancy
Intervention groups
In the intervention group, besides scapular mobilizations, each of the muscles upper trapezius, lower trapezius, subscapularis, pectoralis minor, and serratus anterior would be treated by using dry needling on trigger points.treatment is 3 sessions with two days in between In the control group, patients with trigger points will be treated with 4 sessions of 10 minutes scapular mobilizations including 3 sets with 30 seconds rest in between. treatment will be carried out for 2 weeks (2 sessions a week)
Main outcome variables
Pain, function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190609043846N1
Registration date: 2019-07-05, 1398/04/14
Registration timing: prospective

Last update: 2019-07-05, 1398/04/14
Update count: 0
Registration date
2019-07-05, 1398/04/14
Registrant information
Name
Alireza Kheradmandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3825 6191
Email address
alirezaa228@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-11, 1398/04/20
Expected recruitment end date
2020-01-10, 1398/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of dry needling on pain and function of throwing athletes with scapular dyskinesia
Public title
Effects of manual therapy and dry needling on shoulder pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Engaging in overhead sports Positive indication of Lateral Scapular slide test or Scapular dyskinesis test Trigger points
Exclusion criteria:
Any recent surgery & traumatic injury on shoulder Diabetics Any infections Any usage of any coagulant drugs
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants won't be aware of which group they allocated to. patient assessment and treatment will be carried out by two different therapists
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Oppsite to Felestin Street, Zand Avenue
City
Shiraz
Province
Fars
Postal code
1433671348
Approval date
2019-05-15, 1398/02/25
Ethics committee reference number
IR.SUMS.REHAB.REC.1398.010

Health conditions studied

1

Description of health condition studied
Scapular dyskinesis
ICD-10 code
M99.9
ICD-10 code description
Biomechanical lesion, unspecified

Primary outcomes

1

Description
Pain
Timepoint
Before and after treatment
Method of measurement
Numeric ration acale (NRS)

2

Description
Function
Timepoint
Before and after treatment
Method of measurement
Persian version of DASH questionnaire

3

Description
Changes of scapular dyskinesis ratio
Timepoint
Before and after treatment
Method of measurement
Scapular dyskinesis test, lateral scapular slide test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients with pain and trigger points in each of the muscles: upper trapezius, lower trapezius, subscapularis, pectoralis minor and serratus anterior will be treated with 4 sessions scapular mobilizations and 3 sessions dry needling
Category
Rehabilitation

2

Description
Control group: patients with pain and trigger points in each of the muscles: upper trapezius, lower trapezius, subscapularis, pectoralis minor, and serratus anterior will be treated with 4 sessions scapular mobilizations
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
Alireza Kheradmandi
Street address
Abiverdi No.1 St., Shahid Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
1733-71345
Phone
+98 71 3627 1552
Email
alirezaa228@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
7th floor of Central Building of Shiraz University of Medi cal Sciences,In front of Felestin Street, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Alireza Kheradmandi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 1, Abiverdi Ave., Shahid Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
alirezaa228@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Kamali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 1, Abiverdi Ave., Shahid Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
fahimehkamali@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Alireza Kheradmandi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 1, Abiverdi Ave., Shahid Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
alirezaa228@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data are shareable after samples unidentification
When the data will become available and for how long
9 months after the publication of results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
In order to compare with similar studies
From where data/document is obtainable
Alireza Kheradmandi; email: alirezaa228@gmail.com; phone number: 00989380275871
What processes are involved for a request to access data/document
Applicants can request data retrieval 9 months after the publication of results, and the data will be sent after a maximum of one month.
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