History
# Registration date Revision Id
2 2019-11-12, 1398/08/21 111087
1 2019-11-09, 1398/08/18 110515
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Comparison of the effects of two manual treatments separately and together in treating the active trigger points
Design
Clinical trial with control group, experimental-interventional, convenience sampling, random allocation.
Settings and conduct
The target community is selected from the students of the Rehabilitation School who have active trigger points in upper trapezius muscle. Sampling method is non-random and allocation of samples to groups will be random. Sampling will be done at the Biomechanics Laboratory of the Faculty of Rehabilitation.In this study data analyzer will be blind. The physiotherapist assesses the local pain intensity through (visual analog scale), active cervical contra lateral flexion using Goniometer and pressure pain threshold using algometer. Iranian version of neck disability index questionnaire will be used to determine the level of patient's ability. Variables will be assessed at the first session before and after the intervention and the third session and two weeks after the end of the treatment.
Participants/Inclusion and exclusion criteria
Subjects between 20 and 40 years, Presence of active trigger points, Pain at least 30 mm in visual analog scale, Exclusion criteria: History of whiplash injury, History of head , neck , cervical spine or shoulder surgery, History of cervical radiculopathy, Diagnosed fibromyalgia and myopathy, History of cancer, Pregnancy, History of treatment in a past month, Contraindication of dry needling technique,
Intervention groups
Intervention group 1:Dry needling , three times a week , For 1 week. Intervention group 2: Myofascial release+Dry needling+Myofascial release , three times a week , For 1 week..
Main outcome variables
Pain intensity at the visual scale of pain, Pressure pain threshold, Active cervical contra lateral flexion, Neck disability index Based on forward head posture.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191027045255N1
Registration date: 2019-11-09, 1398/08/18
Registration timing: prospective

Last update: 2019-11-09, 1398/08/18
Update count: 1
Registration date
2019-11-09, 1398/08/18
Registrant information
Name
maryam mobarakzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4466 0339
Email address
mobarakzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness combination of myofascial release technique-dry needling and dry needling on the active trigger points of the upper trapezius muscle.
Public title
Comparison of the combination of myofascial release technique-dry needling and dry needling on the active trigger points of the upper trapezius muscle.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects between 20 and 40 years Presence of active trigger points in upper trapezius musclePain at least 30 mm in visual analog scale
Exclusion criteria:
History of whiplash injury History of head , neck , cervical spine or shoulder surgery History of cervical radiculopathy Diagnosed fibromyalgia and myopathy History of cancer Pregnancy Myofascial therapy within the past month Contraindication of dry needling technique
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a sample of 60 people, 30 cards for each intervention group were considered and placed inside a sealed envelope that is non-transparent to draw then each patient takes one of the cards randomly and their group is identified and the generated sequence is recorded.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2019-05-05, 1398/02/15
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.039

Health conditions studied

1

Description of health condition studied
Myofascial Trigger Points of the Upper Trapezius Muscle
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain intensity in the visual scale of pain
Timepoint
Measure the severity of pain in the first session before and after the intervention and the third session and two weeks after the end of treatment
Method of measurement
Visual analogue scale

2

Description
Pain pressure threshold
Timepoint
Measurement at first session before and after intervention, the third session, and two weeks after the end of treatment
Method of measurement
Digital algometer (Lutron FG-5020)

3

Description
Active cervical contra lateral flexion
Timepoint
Measurement at first session before and after intervention and the third session and two weeks after the end of treatment
Method of measurement
Goniometry

4

Description
Neck disability index
Timepoint
Measurement at first session before intervention, the third session, and two weeks after the end of treatment
Method of measurement
Neck disability index- iranian version questionnaire

5

Description
Forward head postture
Timepoint
Measurement at first session before intervention, and two weeks after the end of treatment
Method of measurement
Craniovertebral Angle

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Dry needle technique is done using sterile needles and disposable Dong Bang with a length of 40 mm and a thickness of 0.25 mm.After the tight bundles are found in the upper trapezius muscle, the therapist inserts the needle at a 30-degree angle and inserts the needle out frequently and then again into another part of the trigger point, this procedure is repeated as long as no other local twitch response is felt. This technique is performed in 3 sessions and three times a week.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
The School of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farshad Okhovatian
Street address
SBMU School of Rehabilitation Sciences., Damavand Ave., Imam Hossein Square (AS).,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1407
Fax
+98 21 7759 1807
Email
Tavan2020@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Fax
+98 21 2243 3455
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
DR. Farshad Okhovatian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
SBMU School of Rehabilitation Sciences., Damavand Ave., Imam Hossein Square (AS).,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1407
Fax
+98 21 7759 1807
Email
Farshadokhovatian1965@Gmail.co

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Mobarakzadeh
Position
MSC Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
SBMU School of Rehabilitation Sciences.,Damavand Ave., Imam Hossein Square (AS).,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1407
Fax
+98 21 7759 1807
Email
m.mobarakzade@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Mobarakzadeh
Position
MSC Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
SBMU School of Rehabilitation Sciences.,Damavand Ave., Imam Hossein Square (AS).,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1407
Fax
+98 21 7759 1807
Email
m.mobarakzade@gmail.com

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
Loading...