Protocol summary

Study aim
examining effects of upper trapezius active trigger points dry needling on postural control and clinical signs in women with chronic non-specific neck pain
Design
A blocking randomized, blinded, controlled clinical trial with a parallel group design of 30 patients.
Settings and conduct
The study is performed in rehabilitation faculty of Iran university of medical sciences. Eligible participants sign consent form and are randomly assigned in intervention or control group by blocking. Pain, pain pressure threshold, cervical side bending and rotation range of motion to both sides, center of pressure displacement and functional disability are assessed at first session before, 2 days and 2 months after intervention. Treatment and assessment is done by separate persons and assessor is blind about participants' groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range from 18-35 years, history of neck pain in the last 3 months, presence of at least 3 and not more than 6 neck pain based on visual analogue scale, presence of at last 3 active trigger points in upper Trapezius muscle. Exclusion criteria: History of surgery or trauma in cervical spine or upper limb , neurological disorders, vestibular disorders, acute cognitive disorders, acute psychopathy
Intervention groups
In intervention group, participants receive dry needling with upper trapezius passive stretch and postural correction education. In control group, stretch and education will be done.
Main outcome variables
pain; pain pressure threshold; side bending & rotation range of motion; postural control; functional rating scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191208045652N1
Registration date: 2020-03-03, 1398/12/13
Registration timing: registered_while_recruiting

Last update: 2020-03-03, 1398/12/13
Update count: 0
Registration date
2020-03-03, 1398/12/13
Registrant information
Name
marzieh Yassin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8052
Email address
m.yassin.pt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of upper trapezius active trigger points dry needling on postural control and clinical signs in women with chronic non-specific neck pain (a single blind randomized clinical trial)
Public title
Effects of upper trapezius active trigger points dry needling in women with chronic non-specific neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 18-35 years History of neck pain in the last 3 months Presence of neck pain at least 3 and not more than 6 based on visual analogue scale during last week Presence of at last 3 active trigger points in upper Trapezius muscle, based on Simons et al criteria: 1) presence of palpable taut band 2) presence of hyperirritable spots in a taut band based on participants' history 3) presence of referral pain in a specific pattern during compression or stretch 4) Patient’s recognition of current pain complaint by pressure on the tender nodule 5) jump sign during palpation of spot
Exclusion criteria:
History of cervical spine or upper limb surgery during the last year History of traumatic injuries in cervical region including fracture, wiplash during the last year Presence of radiculopathic signs Presence of pain in hip, knee & ankle during the last 3 months Presence of neurological disorders including Neuropathy, Myopathy, Parkinson & Cerebellar lesion Presence of vestibular disorders Presence of uncorrected visual & hearing disorders Presence of acute cognitive disorders ( result number < 23 from MMSE questionnaire) Presence of acute psychopathy (based on acquired number from DASS-21 questionnaire) History of rheumatic disorders History of fibromyalgia syndrome based on Rheumatology faculty of USA (1990) History of coagulopathy Pregnancy Diabetes History of any treatment or injection of trigger points during the last 3 months Visible severe postural disorders including kyphosis or scoliosis Skin infection or inflammation History of anti coagulant or immuno suppressive drugs Fear of needle
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple block random allocation method will be used. In order to balance the number of samples in each group, a blocking method with random sizes of 6 will be used and non-transparent envelopes will be used to hide the random assignment. It should be noted that steps are taken to create a randomization sequence by a person who is not involved in any other stage of the research
Blinding (investigator's opinion)
Single blinded
Blinding description
treatment and assessment will be done by separate persons. Analyzer and assessor will be blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of Iran university of medical sciences
Street address
Iran university of medical sciences, next to Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-11-05, 1398/08/14
Ethics committee reference number
IR.IUMS.REC.1398.848

Health conditions studied

1

Description of health condition studied
nonspecific neck pain
ICD-10 code
M70.9
ICD-10 code description
Unspecified soft tissue disorder related to use, overuse and pressure

Primary outcomes

1

Description
postural control
Timepoint
Before intervention, 2 days and 2 months after intervention
Method of measurement
Force plate, kistler, Germany

Secondary outcomes

1

Description
Pain
Timepoint
Before intervention, 2 days and 2 months after intervention
Method of measurement
visual analogue scale

2

Description
pain pressure threshold
Timepoint
Before intervention, 2 days and 2 months after intervention
Method of measurement
Algometer, JTECK, USA

3

Description
side bending & rotation range of motion
Timepoint
Before intervention, 2 days and 2 months after intervention
Method of measurement
iPhone 8 application, goniometer

4

Description
functional rating scale
Timepoint
Before intervention, 2 days and 2 months after intervention
Method of measurement
Persian version of functional rating scale questionnaire

Intervention groups

1

Description
Intervention group:dry needling (Dang bang South Korea, 50*0.3 millimeter) with upper trapezius passive stretch and postural correction education based on pamphlet during 5 sessions, 2 times in a week.
Category
Rehabilitation

2

Description
Control group: upper trapezius passive stretch and postural correction education based on pamphlet during 5 sessions, 2 times in a week.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
physiotherapy clinic of rehabilitation faculty of Iran university of medical sciences
Full name of responsible person
Marzieh Yassin
Street address
Faculty of rehabilitation of Iran university of medical sciences, Madadkaran St, Shah nazari St, Madar Sq, Mirdamad Blv.
City
تهران
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
rehab@iums.ac.ir

2

Recruitment center
Name of recruitment center
Golestan dormitory of Iran university of medical sciences
Full name of responsible person
Marzieh Yasin
Street address
Faculty of rehabilitation of Iran university of medical sciences, Madadkaran St, Shah nazari St, Madar Sq, Mirdamad Blv.
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
rehab@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Abbas Motevalian
Street address
Iran university of medical sciences, Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fereshteh Navaee
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No3, Niayesh St, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1443773488
Phone
+98 21 6651 8660
Email
fereshte.navaei@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marzieh Yassin
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physical therapy department, Rasoul Akram hospital, Niayesh St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 2222 8052
Email
m.yassin.pt@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marzieh Yassin
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy department, Rasoul akram hospital, Niayesh St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 2222 8052
Email
M.yassin.pt@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
Title and more details about the data/document
all data will be shared after unidentified persons
When the data will become available and for how long
accessibility will be 6 months after printing the result
To whom data/document is available
all researchers and scientists, working in academic and scientific institutions, can access to data
Under which criteria data/document could be used
Use of data is only possible by mentioning the name and organizational affiliation of the correspond and co-author of the project and the published article.
From where data/document is obtainable
connect to Fereshteh Navaee by email: fereshte.navaei@gmail.com
What processes are involved for a request to access data/document
if data is used in scientific and therapeutic activities, information will be provided as soon as possible.
Comments
Loading...