Protocol summary

Summary
Objectives: Assessment and treatment of neck myofascial trigger points in female office workers that they work with computers at least for 3 hours in day. Design: Office workers of Tehran University of Medical Sciences participate in this study. 90 patients in 3 groups (ischemic compression, dry needling and control group) participate in one blinded phase 2, Randomized Clinical Trial. Setting and conduct: After referral of the subjects to In patient Rehabilitation Clinic, assessment will be done. If the subjects have trigger points, they will be assigned in 3 groups by randomly. Participants is the staff of Tehran University of Medical Sciences Inclusion & exclusion Criteria: People who experience neck pain at least once in the last week and at least 20 days during the past year; grade 2 in NRS at least ; and People with a history of trauma or surgery in the neck and shoulders are excluded. Intervention: The subjects in 3 groups get ischemic compression and exercise therapy, or dry needling and exercise therapy or only in control group receive exercise therapy Main Outcome Measures: Pain, Range of Motion and muscle strength.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201612071719N4
Registration date: 2017-05-05, 1396/02/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-05, 1396/02/15
Registrant information
Name
khadije Otadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 6134
Email address
k_otadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Tehran University of Medical Science
Expected recruitment start date
2017-01-29, 1395/11/10
Expected recruitment end date
2018-01-30, 1396/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of work related trigger points in neck and shoulder muscle in office workers and comparison of dry needling and ischemic compression in treatment of trigger points
Public title
The effect of physiotherapy on neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: People who experience neck pain at least once in the last week ; People Have neck pain at least 20 days during the past year; Have grade 2 in NRS at least ; Exclusion criteria:People with a history of trauma or surgery in the neck and shoulders are excluded.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 90
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

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittiee of Tehran University of Medical Sciences
Street address
Tehran Univercity of Medical Science. Enghlab Square,Tehran
City
Tehran
Postal code
Approval date
2016-11-20, 1395/08/30
Ethics committee reference number
IR.TUMS.FNM.REC.1395.797

Health conditions studied

1

Description of health condition studied
Neck pain
ICD-10 code
M60, M61,
ICD-10 code description
Muscle disorders

Primary outcomes

1

Description
Pain
Timepoint
Before and after treatment
Method of measurement
Visual analogue scale

2

Description
Muscle strength
Timepoint
Before and after treatment
Method of measurement
By manual dynamometer

3

Description
Range of motion
Timepoint
Before and after treatment
Method of measurement
By goniameter

4

Description
Neck disability index
Timepoint
Before and after treatment
Method of measurement
NDI questionerie

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group : Dry Needling & Exercise Therapy"
Category
Rehabilitation

2

Description
" Control group: Exercise Therapy"
Category
Rehabilitation

3

Description
" Intervention group: Ischemic Compression & Exercise therapy"
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Science, Faculty of Rehabilitation, Physiotherapy Clinic
Full name of responsible person
Khadijeh Otadi
Street address
Pich.e.Shemiran, Enqhelab, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Science
Full name of responsible person
Ms. Norooz zadeh
Street address
The Corner of Qoudes- Keshavarz Blu, Enghelab square
City
Tehran
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, Tehran University of Medical Science
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
Tehran university of Medical Science
Full name of responsible person
Khadijeh Otadi
Position
Assistant proffessor /Ph.D
Other areas of specialty/work
Street address
Piche. shemiran, Enghelab.
City
Tehran
Postal code
Phone
+98 21 7753 5132
Fax
Email
k_otadi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Khadijeh Otadi
Position
Assistant professor/ ph.D
Other areas of specialty/work
Street address
Pich.e. shemiran, Enghelab square
City
Tehran
Postal code
Phone
+98 21 7753 5132
Fax
Email
k_otadi@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran university of Medical Science
Full name of responsible person
Khadijeh Otadi
Position
Assistant professor/ Ph.D
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 7753 5132
Fax
Email
k_otadi@razi.tums.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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