Comparison of immediate effect of whole body vibration, high power pain threshold ultrasound and deep transverse friction massage on treatment of males upper trapezius active myofascial trigger points
Determining the immediate effect of whole body vibration, high power pain threshold ultrasound and deep transverse friction massage and their comparison with each other in the treatment of males upper trapezius active myofascial trigger points
Design
Clinical trial, with parallel groups, double-blind, randomized, phase 3 on 66 patients.
Settings and conduct
patients with trigger point of the upper trapezius muscle referred to the clinic of the Faculty of Rehabilitation of Tehran University of Medical Sciences with age 18 to 45 years are examined. After finding the trigger point based on the findings of travel and simones, the location of the trigger point is marked At the beginning of the session. the active range of motion of the lateral flexion of the neck to the opposite side, the visual analog scale and the pain pressure threshold are recorded by another Therapist.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Age 18 to 45 years
full range of abduction and scaption and internal rotation of the shoulder.
only one trigger point in the upper trapezius muscle based on clinical findings:1- Touching the taut band inside the muscle2- Existence of a very sensitive point inside the taut band3. The presence of pain at least three based on the VAS scale in the initial evaluation4- The occurrence of a refferal and familiar pain pattern when stimulating a taut band.
exclusion criteria
Any neurological disease, fractures, posterior disorders, and any disease or use of substances that impair consciousness
Intervention groups
hole body vibration, high power pain threshold ultrasound ,deep transverse friction massage
Main outcome variables
Measuring pain through visual analog scale
The active range of motion of the lateral flexion of the neck to the opposite side by the goniometer
Pressure threshold pain through the algometer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200518047498N1
Registration date:2020-06-12, 1399/03/23
Registration timing:prospective
Last update:2020-06-12, 1399/03/23
Update count:0
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
Iran Mehrdad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4426 3075
Email address
dpttehran@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-20, 1399/03/31
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of immediate effect of whole body vibration, high power pain threshold ultrasound and deep transverse friction massage on treatment of males upper trapezius active myofascial trigger points
Public title
Comparison of immediate effect of whole body vibration, high power pain threshold ultrasound and deep transverse friction massage on treatment of males upper trapezius active myofascial trigger points
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 45 years
The dominance of the right hand
Ability to perform active movement in the full range of abduction and scaption and internal rotation of the shoulder
There is only one trigger point in the upper trapezius muscle based on clinical findings that have the following characteristics:1- Touching the taut band inside the muscle2- Existence of a very sensitive point inside the taut band3. The presence of pain at least three based on the VAS scale in the initial evaluation4- The occurrence of a refferal and familiar pain pattern when stimulating a taut band.
Exclusion criteria:
History of shoulder surgery or trauma (dislocation, replacement, joint sprain) in the last 6 months
History of chronic or acute diseases such as neurological, cardiac and metabolic diseases
Pregnancy during the test
Skin lesions, infections or inflammation in the trigger point area
Take sedatives before or during treatment
History of neck trauma injuries (Wiplash injury)
History of neck surgery
Any malignancy and bad posture
Fibromyalgia syndrome
Drug abuse
Consumption of corticosteroids
reatment of trigger points in the past month
evere hearing problems - vision and color blindness
Epilepsy
Taking any medication or any specific illness that affects a person's cognitive symptoms
Drink any stimulant drink (such as tea, alcohol, coffee and cocoa) before the test session.
People with lower education than diplomas
Age
From 18 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to www.randomization.com in three groups: WBV, HPPT US, and DTFM. Each participant is assigned a number, and then the numbers Through this site are randomly divided into three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Recording of initial evaluation information and marking of triggerpoint location and reassessment after treatment is performed by one therapist and treatment is performed by another therapist.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs- Tehran University of Medical Sciences
Street address
Floor 13th ,Block A,Central Headquarters of the Ministry of Health, Treatment and Medical Education ,Sima Iran St.Between Flamak South and Zarafshan,
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
IR.TUMS.VCR.REC.1398.903
Health conditions studied
1
Description of health condition studied
myofascial trigger points
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The range of motion of the sideflexion of the neck that is 25 to 45 degrees.
Timepoint
Three times before and immediately after treatment
Method of measurement
The patient is placed in a flat position with a 90-degree flexion of the knee and thigh while the hands are resting on the thighs. The method of measurement is that the Goniameter axis is placed on the spinous process of seventh cervical vertebra. the fixed arm of the Goniameter perpendicular to the ground and its movable arm is placed parallel to the hypothetical vertical line of the head. To measure range of motion, the movement of the head is placed in an anatomical position and the end of the movement of the ear is close to the shoulder.
2
Description
pain Pressure threshold that the pressure sensation becomes a sensation of pain or discomfort
Timepoint
Three times before and immediately after treatment
Method of measurement
The algorithmic device has a disc with a cross-sectional area of 1 cm2, which is pressed perpendicular to the desired point, to start the patient's pain.This test is performed 3 times for each point with a time interval of 30 seconds and an average of three data is recorded.
3
Description
Pain measured by the visual scale of pain, which is between zero and ten
Timepoint
before and immediately after treatment
Method of measurement
The visual scale of the pain is a 100 mm unmarked ruler, with the number zero in the painless position and the number 100 in the most painful position. After acquainting the person with this diagram, we ask him to mark the amount of pain on the ruler. We then measure the distance from the zero point to the mark.
4
Description
age
Timepoint
Before treatment, which should be between 18 and 45 years
Method of measurement
Through a questionnaire and by year
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (WBV Whole Body Vibration): Preliminary explanations about WBV (the vibrating machine to be used in this study will be Power plate, USA, which transmits energy simultaneously and based on the Mass spring system) and how The placement on the vibration surface is given to the person, so that the person is asked to place his hands with the full extension of the elbow so that the joint is not locked, in the middle of the Platform, so that the shoulders are in the flexion position at 90 and There is no internal or external rotation in the upper limb. The head is placed in the direction of the trunk and spine and the person is asked to look at the ground so that it has no rotation or flexion and extension in the neck . The lower limb is kneeling (for safety on the ground). The person is asked to stick his hands firmly to the vibration plate and try to keep his position steady during the vibration. During the time the vibration is applied; If the person expresses discomfort, we will discontinue it. (39) WBV with a frequency of 30 Hz and a range of 5 mm, which includes 5 sets of one minute and one minute of rest between each set, is applied to the person .
Category
Rehabilitation
2
Description
Intervention group2(high power pain threshold ultrasound ): After an introductory explanation of the HPPT US technique, the patient lies in a prone position while the head is in the neutral position and the hands are placed next to the body. the ultrasound probe is placed permanently on the trigger point. The frequency is set to one MHz, and the intensity is increased from 0.5 w / 〖cm〗 ^ 2 to allow the patient to feel the unpleasant sensation. then the probe is hold for 4 seconds and then reduce the intensity by 50% and move the probe over and around the trigger point. This process is done several times over three minutes.
Category
Rehabilitation
3
Description
Intervention group3(deep transverse friction massage ): After an introductory explanation of the DTFM technique, the patient lies supine while the head is in the neutral position and the hands are on the side of the body. The application of force is done by using four fingers, which are reinforced by the middle finger. The force is applied slowly and with a little pain on the trigger point of the upper trapezius muscle for three minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
MohamadReza Hadian
Street address
Faculty of Rehabilitation, Tehran University of Medical SciencesPich Shemiran,Enghelab
City
tehran
Province
Tehran
Postal code
114895611
Phone
+98 21 7753 5132
Email
Rehabilitation@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Faculty of Rehabilitation, Tehran University of Medical SciencesPich Shemiran,Enghelab
City
Tehran
Province
Tehran
Postal code
114895611
Phone
+98 21 7753 5132
Email
dpttehran@gmail.com
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
Iran Mehrdad
Position
Master's degree student in physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No179,infront of drug store ,near moosavi st, somaye Ave
City
Tehran
Province
Tehran
Postal code
1581749711-4
Phone
+98 51 4426 3075
Fax
Email
dpttehran@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Iran Mehrdad
Position
Master's degree student in physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No179,infront of drug store ,near moosavi st, somaye Ave
City
Tehran
Province
Tehran
Postal code
1581749711-4
Phone
+98 51 4426 3075
Fax
Email
dpttehran@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Iran Mehrdad
Position
Master's degree student in physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No179,infront of drug store ,near moosavi st, somaye Ave
City
Tehran
Province
Tehran
Postal code
1581749711-4
Phone
+98 51 4426 3075
Fax
Email
dpttehran@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