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English: Comparison of The Immediate Effects of Electroacupuncture and Laseracupuncture on Pain and Dysfunction Following Chronic Myofascial Neck Pain

Protocol summary

Study aim
Comparison of the immediate effects of two methods of electro-acupuncture and laser-acupuncture on pain reduction, increase in range of motion, increase in pain pressure threshold and disability reduction in patients with chronic myofascial neck pain before, after and one week after intervention.
Design
Randomized(Balanced block Randomization) ,Control ,Single Blind (assessor blinding)Trial
Settings and conduct
By advertisement in TUMS, female students with neck pain will be invited to come to the Physiotherapy Clinic of the Faculty of Rehabilitation. At first, the Inclusion criteria and exclusion criteria of the study will be assess in all the clients and the clients who have all inclusion criteria will participate to the research voluntarily after completing the consent form.secondly, patients will randomize with the Balance Block method. In this study, the assessor is blind.
Participants/Inclusion and exclusion criteria
Girls aged 18 to 35 years with more than 12 weeks of pain in the neck with a pain score of more than 3, based on the VAS scale, without a history of negative response to needle or vascular disease and malignancy that are acupuncture contradictions.
Intervention groups
1) Electro-acupuncture group   The intervention in this group involves electrical stimulation through the needle at the acupuncture points. 2) Laser-acupuncture group Interventions in this group include laser radiation at the acupuncture points . 3) control group The intervention in this group consists of sham laser acupuncture. The patient's condition and acupuncture points are similar to the laser-acupuncture group, with the exception that the laser probe is used off.
Main outcome variables
neck pain (based on VAS scale), cervical range of motion (based on goniometer), pain pressure threshold in cervical region (based on algometer) and disability (based on Neck disability index )

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190104042229N1
Registration date: 2019-07-14, 1398/04/23
Registration timing: registered_while_recruiting

Last update: 2019-07-14, 1398/04/23
Update count: 0
Registration date
2019-07-14, 1398/04/23
Registrant information
Name
Atefe Bahadori Bozchelooee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4420 6707
Email address
bahadori_atefe@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-20, 1398/02/30
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
English: Comparison of The Immediate Effects of Electroacupuncture and Laseracupuncture on Pain and Dysfunction Following Chronic Myofascial Neck Pain
Public title
Acupuncture in Neck Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 35 years old Having more than 12 weeks of history of Myofascial Neck Pain Having pain above 3 is based on the VAS scale, which is considered as moderate pain Satisfaction to participate in the research project "Comparison of The Immediate Effects of Electroacupuncture and Laseracupuncture on Pain and Dysfunction Following Chronic Myofascial Neck Pain"
Exclusion criteria:
History of Injection,Dry needling and Acupuncture In last month History of Muscular Disease such as Fibromyalgia and myopathy History of Neurological Disorders Neck Discopathy and Radiculopathy History of Neck Surgery History of Negative response to Acupuncture or Dry needling Needle Phobia Malignancy and Patients susceptible to infection Having vascular diseases and using anticoagulants pregnancy History of epilepsy or seizure Diabetes During menstruation
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced Block Randomizatin According to the study of three groups in this RCT, six blocks are used to randomize each group , group A, B, C Then, we write the different modes of the six blocks of the AABBCC and place it in the package and the first patient in the study will select one of the packets. For example: ABABCC In this case, the first patient enters group A and the rest of the patients entering the study will be placed in subsequent groups, respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single Blind Which assessor is blind about the type of intervention in each group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Faculty of Nursing and Midwifery, Faculty of Rehabilitation, Tehran University o
Street address
No 72 ,Sayyar Ave ,Rahimi street, 1th Sadeghie Square
City
Tehran
Province
Tehran
Postal code
1451863463
Approval date
2019-04-28, 1398/02/08
Ethics committee reference number
IR.TUMS.FNM.REC.1398.005

Health conditions studied

1

Description of health condition studied
Neck pain
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia

2

Description of health condition studied
Myofascial pain
ICD-10 code
S16
ICD-10 code description
Injury of muscle, fascia and tendon at neck level

Primary outcomes

1

Description
The pain score of people based on the Visual Analog scale
Timepoint
Before the intervention, immediately after the intervention and one week after the intervention
Method of measurement
Visual Analog scale

2

Description
Pain pressure threshold
Timepoint
Before the intervention, immediately after the intervention and one week after the intervention
Method of measurement
pressure algometer

3

Description
Disability
Timepoint
Before the intervention, immediately after the intervention and one week after the intervention
Method of measurement
Neck Disability index Questionnaire

4

Description
cervical range of motion
Timepoint
Before the intervention, immediately after the intervention and one week after the intervention
Method of measurement
Goniometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Electroacupuncture:In this group, 8 acupuncture points are introduced to reduce the myofscial neck pain. The needle is applied and the electrical current is connected to the needles with specific therapeutic parameters and exposed to electrical stimulation for 20 minutes.
Category
Treatment - Devices

2

Description
Intervention group: Laseracupuncture:In this group, low-power laser waves with specific parameters will radiate at 8 acupuncture points which is similar to the first group.
Category
Treatment - Devices

3

Description
Control group: Sham Laser-acupuncture:in This group the off laser probe will be use at the similar points of the last two groups .
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Science
Full name of responsible person
Atefe Bahadori
Street address
ُSafi Alishah,Pich-e-Shemiran,Enghelab St,Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
bahadori_atefe@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
dr Seyyed Mohsen Mir
Street address
Pich-e-Shemiran, Enghelab st, Tehran
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7763 6041
Email
rehabilitation@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Atefe Bahadori Bozchelooee
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 72 , Sayyar Ave, Rahimi Blvd, 1sth Sadeghie Square,Tehran Town
City
Tehran
Province
Tehran
Postal code
1518932555
Phone
+98 21 4420 6707
Fax
Email
bahadori_atefe@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atefe Bahadori Bozchelooee
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 72 , Sayyar Ave, Rahimi Blvd, 1sth Sadeghie Square,Tehran Town
City
Tehran
Province
Tehran
Postal code
1518932555
Phone
+98 21 4420 6707
Fax
Email
bahadori_atefe@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atefe Bahadori Bozchelooee
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 72 , Sayyar Ave, Rahimi Blvd, 1sth Sadeghie Square,Tehran Town
City
Tehran
Province
Tehran
Postal code
1518932555
Phone
+98 21 4420 6707
Fax
Email
bahadori_atefe@yahoo.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Reproducible data includes general information about patients, their medical conditions and factors measured before and after their intervention, and personal information of the patients will not be published.
When the data will become available and for how long
6 months after results publication
To whom data/document is available
academic researchers
Under which criteria data/document could be used
The data will sent to valid academic emails for only studying and reviewing the results and will not allow any analysis or printing.
From where data/document is obtainable
Applicants can request to receive information by sending an email to the following e-mail address bahadori_atefe@yahoo.com
What processes are involved for a request to access data/document
The applicant can declare an application by sending a message from a valid academic email, and the requested information will be sent within a maximum of two weeks by email.
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