Protocol summary

Summary
The aim of study is to evaluate the effects of dry needling on pressure pain threshold, pain and patients disability with active trigger points in the upper trapezius muscle. The study is quasi-experimental, a clinical trial that samples will be selected non-random of 23 people . Inclusion criteria will be the age of 50-30 “More than three months of pain and trigger points with palpation and exclusion criteria will be the patients with systemic diseases, ulceration and skin diseases and previous trauma in the neck . The patient will complete the Questionnaire Disability Index before the intervention and will determine pain intensity by the VA and pressure pain threshold will be recorded by algometry. then the patients will be needled and algometry will be done immediately after that. A week later disability, pain and pressure pain threshold will be assessed and recorded

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016061528474N1
Registration date: 2016-07-01, 1395/04/11
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Reza Ebrahimi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3227 3547
Email address
ebrahimir75@yahoo.com
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of One Session Dry Needling on Pain, Pressure Pain Threshold and Disability in patient with Active Trigger Points in the Upper Trapezius Muscle
Public title
Effect of Dry Needling on Active Trigger Points
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 50-30 , More than three months of pain and trigger points with palpation Exclusion criteria : patients with systemic diseases, Ulceration and skin diseases and previous trauma in the neck
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 23
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2015-09-16, 1394/06/25
Ethics committee reference number
94/3/491

Health conditions studied

1

Description of health condition studied
Active Trigger Points
ICD-10 code
M96.9
ICD-10 code description
Postprocedural musculoskeletal disorder, unspecified

Primary outcomes

1

Description
Pressure Pain Threshold
Timepoint
One week after intervention
Method of measurement
Algometry

2

Description
Pain
Timepoint
Before the intervention
Method of measurement
Visual analogue scale

3

Description
Disability
Timepoint
Before the intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Age
Timepoint
Before the intervention
Method of measurement
Years

2

Description
Height
Timepoint
Before the intervention
Method of measurement
Cm

3

Description
Weaight
Timepoint
Before the intervention
Method of measurement
Kg

Intervention groups

1

Description
Dry needling
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashani Medical Educational Center
Full name of responsible person
Ebrahimi Reza
Street address
Kashani St
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Navid Taheri
Street address
Isfahan
City
Isfahan
Grant name
--------------------------------------------------------------
Grant code / Reference number
------------------------------------------------------------
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Ebrahimi Reza
Position
MSc Student
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 5007
Fax
-----------------------------------------------------------------
Email
ebrahimir75@yahoo.com
Web page address
--------------------------------------------------------------

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Navid Taheri
Position
Instructor
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
--------------------
Phone
+98 31 3792 5007
Fax
Email
N_taheri@rehab.ac.ir
Web page address
-----------------------------------------------------------------------

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Reza Ebrahimi
Position
MSc Student
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
--------------------
Phone
+98 31 3792 5007
Fax
Email
ebrahimir75@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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