Comparison of Effects of Dry needling and High Power Laser Therapy on Clinical Signs in Females with Upper Trapezoid Muscle Active Trigger Points (a Single-Blind Randomized Clinical Trial)
Comparison of Effects of Dry Needling and High Power Laser on clinical sign in Females with Upper Trapezoid Muscle Active Trigger Points
Design
A randomized (using block randomization method), single blinded, clinical trial with two parallel group design and a sample size of 30 patients
Settings and conduct
The study is performed in rehabilitation faculty of Iran University of Medical Sciences. Then eligible participants sign informed consent form and are randomly assigned to two groups of dry needling and high power laser by blocking. Treatment and assessment is done by separate persons and assessor and analyzer of data will be kept blind. The assessor is present only at the time of assessment (before and after treatment).
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-35 years old; 30 < pain score< 60 mm based on visual analogue scale; presence of maximum of 3 active trigger points in upper trapezius muscle; history of trigger point pain> 3 months in trapezius muscle
Non inclusion criteria: history of surgery; fractures and traumatic injuries to to cervical spine; History of neurological; rheumatic and cognitive disorders; presence of symptoms of radiculopathy; malignancy; pregnancy
Intervention groups
Intervention group 1: participants received dry needle, passive stretch of upper trapezius muscle and postural correction education. Intervention group 2: participants received high-power laser, passive stretch of upper trapezius muscle and postural correction education.
Main outcome variables
Pain; pain pressure threshold; cervical lateral flexion and rotation to both; neck disability index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045652N2
Registration date:2020-03-27, 1399/01/08
Registration timing:registered_while_recruiting
Last update:2020-03-27, 1399/01/08
Update count:0
Registration date
2020-03-27, 1399/01/08
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
2020-01-21, 1398/11/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effects of Dry needling and High Power Laser Therapy on Clinical Signs in Females with Upper Trapezoid Muscle Active Trigger Points (a Single-Blind Randomized Clinical Trial)
Public title
Effect of ِDry needling and High Power Laser Therapy in treatment of Trigger Points
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with age range of 18-35 years
The presence of pain score between 30-60 mm according to visual analogue scale during rest or movement
The presence of maximum of three active trigger points in the upper trapezoid muscle
The history of trigger point pain for more than three months
The presence of taut band in the upper trapezoid muscle during the touch
The presence of sensitive and painful points in the response to 25 N pressure
The presence of referred pain pattern in the response to pressure
Ability to reading and writing to Persian language
Exclusion criteria:
The history of any treatment for trigger points and steroid injections over the past 3 months
The history of fibromyalgia syndrome
The history of surgery and fractures in the neck
The presence of symptoms of cervical disc disorders such as radiculopathy
The presence of neurological diseases
The history of malignancy
Pregnancy
Severe postural disorders such as scoliosis and kyphosis
The presence of infection and skin ulcers
The history of receiving anticoagulants
Fear of Needle
The presence of communication and cognitive impairment
The history of trauma such as whiplash injuries
Patient dissatisfaction to continuing treatment and assessment
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
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
Assessment and treatment will be performed by two individuals. Assessor and analyzer the data are those who are unaware of the grouping and will be unaware of which group each subject belongs to. The assesor is present only at the time of assessment (before and after treatment).
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
2020-01-14, 1398/10/24
Ethics committee reference number
IR.IUMS.REC.1398.1044
Health conditions studied
1
Description of health condition studied
Upper trapezius muscle active trigger point
ICD-10 code
M70.9
ICD-10 code description
Unspecified soft tissue disorder related to use, overuse and pressure
Primary outcomes
1
Description
Pain
Timepoint
Pain before intervention, 2 days and 2 months after intervention
Method of measurement
pain with visual analogue scale
Secondary outcomes
1
Description
Pain pressure threshold
Timepoint
Before intervention, 2 days and 2 months after intervention
Method of measurement
Algometer J-Tech, USA
2
Description
Side bending & rotation range of motion
Timepoint
Before intervention, 2 days and 2 months after intervention
Method of measurement
iPhone 8 application, goniometer
3
Description
Neck Disability Index
Timepoint
Before intervention, 2 days and 2 months after intervention
Method of measurement
Persian version of Neck Disability Index questionnaire
Intervention groups
1
Description
Intervention group 1: dry needling (Dang bang South Korea, 50*0.3 mm) with passive stretching and posture correction education based on pamphlet during 5 sessions, 2 times a week, for 3 weeks.
Category
Rehabilitation
2
Description
Intervention group 2: High power laser (New Age, Italy) with wavelength of 1064 nm, power 14 W, frequency 100 Hz with passive stretching and posture correction education based on pamphlet during 5 sessions, 2 times a week, for 3 weeks.
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; Iran University of Medical Sciences; Madadkaran street, Shahid Shahnazari street, Madar square, Mirdamad boulevard
City
Tehran
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
Physical therapy department, Rasoul Akram hospital, Niayesh street, Sattarkhan street
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
Physical therapy department, Rasoul Akram hospital, Niayesh street, Sattarkhan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 2222 8052
Email
Azize.parande@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 can be shared after unidentified people
When the data will become available and for how long
starting accessibility 6 months after printing results
To whom data/document is available
The information is accessible to all researchers working in academic and scientific institutions.
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 Azize Parandnia by email: azize.parande@gmail.com
What processes are involved for a request to access data/document
If information is used in scientific and therapeutic activities, information is provided as soon as possible.