Comparison of the effect of Manual pressure release and Algometer pressure release on morphological characteristics in latent upper trapezius muscle trigger points
A Comparative Study of the Effects of manual pressure release and pressure release with algometer on latent trigger points of upper trapezius muscle
Design
clinical trial of manual pressure release intervention group and intervention group pressure release with algometer؛on 40 samples؛with paralles groups؛randomized
Settings and conduct
Therapeutic interventions on patients with latent upper trapezius trigger points in two separate groups and 5 sessions of treatment in the physiotherapy clinic of the Faculty of Rehabilitation of Shahid Beheshti University of Medical Sciences is underway؛the study variables included pain;pressure pain threshold;neck lateral flexion range of motion;thicknes;histogram;pennation angle of upper trapezius muscle;measurement of variables is done before and after intervention and after fifth session;the study variables is followed after two weeks.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: women aged 20 to 40 years; presence of latent trigger points in the muscle according to criteria:presence of palpable taut bundles in the skeletal muscle؛presence of a painful spot in the tight bundle؛presence of at least 1 tender point in palpable taut band in response to a pressure of 25 newtons per square meter by the therapist؛creation of pain at least 3 of 10 in visual scale of pain in initial assessment
Intervention groups
manual pressure release group:manually enter the pressure on latent trigger points of upper trapezius(LTOUT)؛pressure release with algometer group:enter the pressure with algometer on LTOUT
Main outcome variables
pain;prassure pain threshold;neck lateral flexion range of motion;thickness;histogram; muscle fiber pennation angle;quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180602039945N1
Registration date:2019-03-17, 1397/12/26
Registration timing:retrospective
Last update:2019-03-17, 1397/12/26
Update count:0
Registration date
2019-03-17, 1397/12/26
Registrant information
Name
Rahimeh Fazeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7631 6820
Email address
rahimehfazeli@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-04, 1397/03/14
Expected recruitment end date
2018-11-20, 1397/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Manual pressure release and Algometer pressure release on morphological characteristics in latent upper trapezius muscle trigger points
Public title
effect of Manual pressure release and Algometer pressure release on morphological characteristics in upper trapezius muscle with latent trigger points
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with age ranges from 20 to 40 years
presence of latent trigger points in the muscle based on the therapist's assessment
presence of palpable taut bundles in skeletal muscle
presence of at least 1 tender point in taut bundle in response to the pressure of 25 Newtons per square meter by the therapist
Creation of pain at least 3 of 10 in visual scale of pain in Initial assessment
Exclusion criteria:
Diagnosis of fibromyalgia syndrome
History of severe head and neck injury and whiplash injury
History of cervical spine surgery and fracture and hypermobility or instability
Diagnosis of radiculopathy, myelopathy and malignancy
Treating the trigger points in a past month
If patients are not willing to continue to work for any reason
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random randomization method with random number table is performed
Blinding (investigator's opinion)
Single blinded
Blinding description
After fully explaining the study process to the participants and informed consent by the patient ، no information was given on the type of treatment and the specificities of intervention groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Kianshahr
City
Tehran
Province
Tehran
Postal code
1858777796
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.715
Health conditions studied
1
Description of health condition studied
latent trigger points
ICD-10 code
M79.9
ICD-10 code description
Soft tissue disorder, unspecified
Primary outcomes
1
Description
Pain intensity based on the visual analogue scale
Timepoint
Before intervention; immediately after intervention; fifth session; 15 days after the last session
Method of measurement
Visual analogue pain
2
Description
Pressure pain threshold
Timepoint
Before intervention; immediately after intervention; fifth session; 15 days after the last session
Method of measurement
With algometer device
3
Description
Neck lateral flexion range of motion
Timepoint
Before intervention; immediately after intervention; fifth session; 15 days after the last session
Method of measurement
With goniometer device
4
Description
Thickness of upper trapezius muscle
Timepoint
Before intervention;fifth session; 15 days after the last session
Method of measurement
With the help of ultrasonography and measuring the vertical distance between two fascias
5
Description
Histogram of upper trapezius muscle
Timepoint
Before intervention;fifth session; 15 days after the last session
Method of measurement
With the help of ultrasonography and measure the mean light
6
Description
P angle in upper trapezius muscle fibers
Timepoint
Before intervention;fifth session; 15 days after the last session
Method of measurement
With the help of ultrasonography and measuring the angle of the fibers
7
Description
quality of life
Timepoint
Before the intervention; fifth session
Method of measurement
Quality of life questionnaire with 36 items
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group:manual pressure release.It is a popular, safe and effective treatment method that is carried out by a skilled physiotherapist.It is continuous manual pressure with tolerable pain that is apply with fingertip or thumb over the tissue barrier at the trigger point.
Category
Rehabilitation
2
Description
Second intervention group: pressure release with algometer.It is continuous pressure with tolerable pain that is carried out by the therapist that mechanical therapeutic algometer is used for apply continuous and effective pressure and maintain pressure by therapist.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences
Full name of responsible person
Farideh Dehghan Monshadi
Street address
Damavand Avenue, facing Bu-Ali Hospital, Faculty of Rehabilitation Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
manshadi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Akbarzade Baghban
Street address
Damavand Avenue, opposite Bouali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
akbarzad@smbu.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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rahimeh Fazeli
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Kayanshahr, Salimi St., No. 11
City
Tehran
Province
Tehran
Postal code
1858777796
Phone
+98 21 7631 6820
Email
rahimehfazeli@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedighe Sadat Naimi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Damavand Avenue, Opposite of Bouali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
Naimi_Se@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rahimeh Fazeli
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Kayanshahr, Salimi St., No. 11
City
Tehran
Province
Tehran
Postal code
1858777796
Phone
+98 21 7631 6820
Email
rahimehfazeli@yahoo.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
Only part of the data, such as the information on the main outcome or the like, can be shared
When the data will become available and for how long
Start the access period immediately after printing the results
To whom data/document is available
Researchers working in academic and academic institutions
Under which criteria data/document could be used
No bets
From where data/document is obtainable
To the e-mail address:Rahimehfazeli@smbu.ac.ir
What processes are involved for a request to access data/document