Protocol summary

Study aim
Comparison between immediate effect of Superficial and Deep Dry Needling on Surface Electromyography in women with Upper Trapezius Active Myofascial Trigger Points
Design
Quasi-experimental and double-blinded randomized clinical trials
Settings and conduct
A study is conducted at the Physiotherapy Clinic of the Faculty of Rehabilitation, Isfahan University of Medical Sciences. In this study, participants select from women with unilateral neck or shoulder pain with at least one active myofascial trigger point in the upper trapezius muscle and then randomly divided into superficial and deep dry needling group. After completing the consent form and the initial assessment, the participants based on their group, will receive one session dry needling.It should be noted that both the evaluator and participants are blind to the therapeutic groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: literate women 18 to 50 years, unilateral neck or shoulder pain with at least one active myofascial trigger point in the upper trapezius muscle for at least 3 months, not receiving analgesic therapy by patients. Exclusion criteria: fear of dry needling, local and systematic infection, people with fibromyalgia and neck osteoarthritis, people who used anticoagulant drugs, acute muscle trauma, history of neck or shoulder surgery, history of receiving dry needling at last 6 months, receiving physical therapy in the past month, dry needling contraindications like pregnancy, allergy, existence of implants and pacemakers
Intervention groups
For first group, deep needle inserted into myofascial trigger point with 10 times in and out movement and for second group the superficial needle inserted into superficial tissue above the myofascial trigger point and kept in for 2 to 3 minutes.
Main outcome variables
Surface Electromyography activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180918041059N1
Registration date: 2018-10-02, 1397/07/10
Registration timing: registered_while_recruiting

Last update: 2018-10-02, 1397/07/10
Update count: 0
Registration date
2018-10-02, 1397/07/10
Registrant information
Name
Zahra Hosseyninejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3271 5289
Email address
z.hosseninejad69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-21, 1396/08/30
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between immediate effect of Superficial and Deep Dry Needling on Surface Electromyography in women with Upper Trapezius Active Myofascial Trigger Point
Public title
Comparison between Superficial and Deep Dry Needling on Surface Electromyography of Myofascial Trigger Point
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Literate women 18 to 50 years Unilateral neck or shoulder pain with at least one active Myofascial Trigger Point in the upper trapezius muscle for at least 3 months Not receiving analgesic therapy by patients
Exclusion criteria:
Fear of dry needling Local and systematic infection People with fibromyalgia and neck osteoarthritis People who used anticoagulant drugs Acute muscle trauma History of neck or shoulder surgery History of receiving dry needling at last 6 months Receiving physical therapy in the past month Dry needling contraindications like pregnancy, allergy, existence of implants and pacemakers
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization through random - number table
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, a double blinded method is used in which both the participants and the evaluator are unaware about the type and group of treatment .
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Room 209, 2nd Floor, Building number 4, Isfahan University of Medical Sciences, Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-07-25, 1396/05/03
Ethics committee reference number
IR.MUI.REC.1396.3.308

Health conditions studied

1

Description of health condition studied
upper trapezius myofascial trigger point
ICD-10 code
M62
ICD-10 code description
Other disorders of muscle

Primary outcomes

1

Description
Surface electromyography activity
Timepoint
Before, immediately and one week after the intervention
Method of measurement
Surface electromyography device

Secondary outcomes

1

Description
Neck disability
Timepoint
Before and one week after the intervention
Method of measurement
Neck disability index questionnaire

Intervention groups

1

Description
Intervention group: For first group, deep needle (height: 40 millimeter, diameter: 0.2 millimeter) inserted into myofascial trigger point with 10 times in and out movement.
Category
Rehabilitation

2

Description
Intervention group: for second group the superficial needle (height: 13 millimeter, diameter: 0.2 millimeter) inserted into superficial tissue above the myofascial trigger point and kept in for 2 to 3 minutes
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic, Faculty of Rehabilitation, Isfahan University of Medical Sciences
Full name of responsible person
Navid Taheri
Street address
Isfahan University Of Medical Sciences, Hezarjerib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5222
Email
n_taheri@rehab.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Isfahan University Of Medical Sciences, Hezarjerib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81745-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Navid Taheri
Position
Ph.D., Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Isfahan University Of Medical Sciences, Hezarjerib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
87746-73461
Phone
+98 31 3792 5043
Email
n_taheri@rehab.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Navid Taheri
Position
Ph.D., Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Isfahan University Of Medical Sciences, Hezarjerib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5043
Email
n_taheri@rehab.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Navid Taheri
Position
Ph.D., Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Isfahan University Of Medical Sciences, Hezarjerib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5043
Email
n_taheri@rehab.mui.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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