A Comparative Study of Sonographic and Clinical Parameters of Trigger Point of the Upper Fiber of the Trapezius Muscle Following " Dry Needling " and " Intramuscular Electrical Stimulation " (IMES) through Needle.
The aim of this study is to comprehensively evaluate the effectiveness and comparison of each of the two interventions in needling and intramuscular electrical stimulation using objective tools such as sonographic parameters as well as clinical parameters on the symptoms of the upper trapezius muscle trigger points.
Design
Clinical trial with control group, parallel groups, single-blind, randomized, on 30 patients. Balanced blocks randomization are used.
Settings and conduct
School of Rehabilitation, Shahid Beheshti University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.Active trigger points in the upper trapezius muscle
2. Pain associated with the trigger point of the upper trapezius muscle above 3 on the VAS scale
3. Age: 18-30 years.
Exclusion criteria:
1. Injections or other treatments for trigger points since one month before the research.
2. History of muscle diseases such as fibromyalgia and myopathy.
3. Malignancy or exposed to infection.
4. Central and peripheral neurological disorders.
5. Skin damage in the trigger point area.
6. Taking sedatives before and during treatment.
7. Radicular pain and history of neck and shoulder surgery.
8. History of bad response to acupuncture or dry needling.
9. Pregnancy.
10. Taking anticoagulants.
11. Significant fear of dry needling.
12. Vascular disease.
13. Diabetes.
14. History of migraine.
15. History of accident or trauma in the relevant areas.
Pain; Pain pressure threshold; Neck range of motion, Disability rate; Ultrasonic parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170616034567N2
Registration date:2020-09-11, 1399/06/21
Registration timing:registered_while_recruiting
Last update:2020-09-11, 1399/06/21
Update count:0
Registration date
2020-09-11, 1399/06/21
Registrant information
Name
monavar hadizdeh
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7754 2057
Email address
hadizadeh-m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2020-12-05, 1399/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of Sonographic and Clinical Parameters of Trigger Point of the Upper Fiber of the Trapezius Muscle Following " Dry Needling " and " Intramuscular Electrical Stimulation " (IMES) through Needle.
Public title
Investigation of the effects of intramuscular electrical stimulation on trigger points
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Active trigger points in the upper trapezius muscle
Pain associated with the upper trapezius muscle trigger point above 3 based on the VAS scale which is considered as moderate pain.
Age: 18-35 years.
Exclusion criteria:
Perform injections or other treatments for trigger points in the period of one month before the research.
Previous history of muscle diseases such as fibromyalgia and myopathy.
Malignancy or patients prone to infection.
Central and peripheral neurological disorders.
Skin damage in the trigger point area.
Taking sedatives before and during treatment.
Radicular pain and history of neck and shoulder surgery.
Previous history of bad response to acupuncture or dry needling.
Pregnancy.
Taking anticoagulants.
Significant fear of dry needling.
Vascular disease.
Diabetes.
History of migraine.
History of accident or trauma in the relevant areas.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random method: balanced block randomization
Allocation concealment: sealed envelope
How to do randomization:
To randomize by balanced block randomization method, we do the following:
Intervention group code: A
Control group code: B
1. Due to having two groups, the designated blocks are four (AABB). The group codes in these blocks can be designed in six ways.
1(AABB), 2(BBAA), 3(ABAB), 4(BABA), 5(ABBA), 6(BAAB)
۲. Depending on the size of the sample of thirty, 8 of these blocks, which are 32 codes in total, are randomly placed next to each other.
3. Then, each of these codes, which represents the treatment group of each patient, is placed in a sealed envelope, and these envelopes are placed next to each other.
These steps will be performed by another person and the lead researcher does not know each person's group until the moment of intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the data analyzer is blinded because they do not known each patient belongs to which intervention group.
To do this, the names of the groups are coded (intervention group: A and control group: B) and data analyzer will not know the code of each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Shahid Beheshti University of Medical Sciences
Street address
No. 2, Shahid Beheshti University of Medical Sciences, Evin Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-08-09, 1399/05/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.480
Health conditions studied
1
Description of health condition studied
Upper trapezius muscle trigger point
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
Before, after and one month after treatment
Method of measurement
by Visual Analogue Scale
2
Description
Pain pressure threshold
Timepoint
Before, after and one month after treatment
Method of measurement
by algometer
3
Description
Neck range of motion
Timepoint
Before, after and one month after treatment
Method of measurement
lateral flexion and rotation by goniometer
4
Description
Disability
Timepoint
Before, after and one month after treatment
Method of measurement
by Neck Disability Index
5
Description
Ultrasonic parameters
Timepoint
Before, after and one month after treatment
Method of measurement
by sonography device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intramuscular electrical stimulation, The intervention in this group was intramuscular electrical stimulation in which the patient was placed lying on his stomach. The muscle is then touched and the needle is inserted into the trigger point and the therapist's fingers. In the next step, the cathode electrode is connected to the needle and the other pole is placed on the spinous process of the seventh vertebra of the neck by a circular electrode. This will apply the current to the trigger point for 10 minutes. At the end of the mentioned period, first the current intensity is zero and then the device is removed from the patient's body and the needle is removed.
Category
Treatment - Other
2
Description
Control group: Dry Needling Group, In this group of patients, needling will be performed for the patient as in the previous group. In this way, after the needle enters the trigger point, the needle will move in and out. This process will continue until the insertion and removal of the twitch needle is no longer seen at the trigger point 10 times, then the needle will leave the individual muscle.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of rehabilitation, Shahid Beheshti University of medical sciences
Full name of responsible person
Mohammad mohsen Roostaee
Street address
Faculty of rehabilitations, Damavand Ave
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
hadizade.mahsa1992@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
SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
20
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
Monavar Hadizadeh
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation, Shahid Beheshti University of Medical Sciences, Damavand Ave
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
Hadizadeh.mahsa1992@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Rahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation, Shahid Beheshti University of Medical Sciences, Damavand Ave
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
arahimiuk@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Monavar Hadizadeh
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation, Shahid Beheshti University of Medical Sciences, Damavand Ave
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
hadizade.mahsa1992@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
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