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Trial registered on ANZCTR


Registration number
ACTRN12614000192684
Ethics application status
Approved
Date submitted
12/02/2014
Date registered
21/02/2014
Date last updated
21/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison between different modes of real-time sonoelastography in visualizing myofascial trigger points in low back muscles
Scientific title
Visualization of active and latent myofascial trigger points in low back muscles by real-time sonoelastography in normal subjects and patients with low back pain
Secondary ID [1] 284086 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myofascial Trigger Points 291157 0
Low back dysfunction due to postural faults 291180 0
Condition category
Condition code
Musculoskeletal 291492 291492 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Real-Time Sonoelastography; uses the principle that tissue compression produces strain (displacement). Strain indicates stiffness and the relative deformation, where stiff tissue shows less strain compared to the softer tissue while they are both under identical force. Two modes were used; vibration sonoelastography (VSE) (E-color mode) consists of a color flow Doppler system that can image vibration patterns resulting from the low-frequency shear waves that are propagated through deep tissue. The 2-Dimensional grey scale ultrasound (2DGSUS) (B-mode), with frequency 7-14 MHz was implemented on the clinically identified myofascial trigger points (MTrPs) to assess echogenicity of MTrPs and surrounding myofasical structure.
Both modes were implemented on a single occasion, directly after clinical identification of MTrPs, and it took thirty minutes to scan all MTrPs in the quadratus lumborum, longissimus thoracis, piriformis, and gluteus medius
Intervention code [1] 288781 0
Diagnosis / Prognosis
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291469 0
Tissue strain of MTrPs and its surrounding myofasical structure as well as the strain ratio by vibration sonoelastography
Timepoint [1] 291469 0
Directly after clinical identification of MTrPs by palpation and algometric measurements
Secondary outcome [1] 306841 0
Vibration sonoelastography assessed stiffness through a colored image, where the blue color represented the stiffest tissue, while the green, yellow and red represented the softer tissue.
Timepoint [1] 306841 0
Directly after clinical identification of MTrPs by palpation and algometric measurements
Secondary outcome [2] 306842 0
2-Dimensional grey scale ultrasound (B-mode), was implemented on the clinically identified MTrPs to assess echogenicity of MTrPs and surrounding myofasical structure.
Timepoint [2] 306842 0
Directly after clinical identification of MTrPs by palpation and algometric measurements
Secondary outcome [3] 306888 0
After completion of the imaging procedure by both modes, the images were printed out and a second radiologist was asked to identify, locate and score the MTrPs on the 2-Dimensional grey scale ultrasound image; where he was blinded from the colored vibration sonoelastography image at first, then he was shown the colored E-mode image and was asked to locate and score MTrPs again. This was done to measures accuracy of both modes.
Timepoint [3] 306888 0
After completion of the imaging procedure by both modes

Eligibility
Key inclusion criteria
To be included in the study, the subjects with Active-MTrPs (A-MTrPs) must have experienced low back pain consistently over the past 3 months prior to the investigation and did not receive any physical therapy for at least 3 months. The cause of the back pain was diagnosed by an orthopedic physician to be low back dysfunction, due to postural imbalances, where an X-ray and MRI ruled out any spinal involvement. Subjects with Lantent-MTrPs (L-MTrPs) were pain-free subjects (they had no low back pain over the past 3 months), however they were referred for treatment for other conditions. Normal (20-24.9) and overweight (25-29.9) body mass index subjects were included in the study.
Minimum age
25 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusive criteria included active rheumatoid arthritis, fractures and structural deformities of trunk, hip, knee and ankle joints, neurological symptoms, disc prolapse, previous spinal surgery, pregnancy and body mass index of class II to III.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects with Active-MTrPs must have experienced low back pain consistently over the past 3 months prior to the investigation and did not receive any physical therapy for at least 3 months. The cause of the back pain was diagnosed by an orthopedic physician to be low back dysfunction, due to postural imbalances, where an X-ray and MRI ruled out any spinal involvement. Subjects with L-MTrPs were pain-free subjects (they had no low back pain over the past 3 months), however they were referred for treatment for other conditions. All subjects were asigned from the outpatient clinic of School of Physical Therapy, Cairo University.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Two Groups; an Active MTrP and Latent MTrP
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analysis was done with IBM SPSS Statistics 21.0. Descriptive statistics were used to compare the means and standard deviations of subject’s characteristics. The Independent t test and paired-samples t test were used for the comparison of within and between groups. Wilcoxon matched pairs test was used to compare echo scores. The level of significance was accepted as P<.05. Positive and negative predictive values of the ROC curve were used to measure accuracy. ICC (Intr-aclass correlation coefficient) test was used to measure intrarater reliability of the pressure algometer. A statistical power analysis suggested that sample sizes of 50 subjects were adequate to achieve more than 80% power.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/2011
Actual
10/01/2011
Date of last participant enrolment
Anticipated
20/07/2012
Actual
20/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5819 0
Egypt
State/province [1] 5819 0
Cairo

Funding & Sponsors
Funding source category [1] 288716 0
University
Name [1] 288716 0
Cairo University
Country [1] 288716 0
Egypt
Primary sponsor type
University
Name
School of Physical Therapy, Cairo University
Address
7 Ahmed Elzaiat St. Ben Elsaryat -12612- EI Dokki-Giza
Country
Egypt
Secondary sponsor category [1] 287418 0
None
Name [1] 287418 0
Address [1] 287418 0
Country [1] 287418 0
Other collaborator category [1] 277822 0
University
Name [1] 277822 0
School of Medicine, Cairo University
Address [1] 277822 0
Kasr Al Ainy St. 11562, Cairo, Egypt
Country [1] 277822 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290552 0
School of Physical Therapy, Cairo University
Ethics committee address [1] 290552 0
7 Ahmed Elzaiat St. Ben Elsaryat - 12612- EI Dokki-Giza
Ethics committee country [1] 290552 0
Egypt
Date submitted for ethics approval [1] 290552 0
Approval date [1] 290552 0
14/11/2010
Ethics approval number [1] 290552 0

Summary
Brief summary
The root of the difficulty in the diagnosis of Myofascial Pain Syndrome; that remains highly debated, lies in the difficulty to quantitate their symptoms (as pain and stiffness) and their semi-qualitative physical findings; that are localized taut bands of increased tone, enclosing even more confined MTrPs of tenderness. Physical examination and pain pressure threshold values depend on the sensitivity, discretion and skill of the clinician, as well as the inconsistencies of the patient’s feeling of pain. There lacks objective means to quantify myofascial trigger points (MTrPs) and their core features. The aim of this research was to compare (1) MTrPs and surrounding myofascial tissue by 2-dimensional grey scale ultrasound (2DGSUS) and vibration sonoelastography (VSE); (2) accuracies of both these modes in visualizing MTrPs; (3) active and latent MTrPs by VSE; and (4) accuracy to visualize deep and superficial located MTrPs.
Trial website
Trial related presentations / publications
Public notes
This was a PhD dissertation, where first the proposal was accepted on 14/11/2010 by the ethical council of School of Physical Therapy, Cairo University, then the proposal was accepted by the president of Cairo University on 15/12/2010.

The dissertation defense was held on the 31/12/2012, where the acceptance of this dissertation was achieved on 14/2/2013 by the school of physical therapy, Cairo university, then the president of Cairo University on 5/03/2013, and PhD degree was granted

Contacts
Principal investigator
Name 46230 0
Dr Mary Kamal Nassif Takla
Address 46230 0
Lecturer of Physical Therapy
School of Physical Therapy, Cairo University

Work address:7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 12612
Country 46230 0
Egypt
Phone 46230 0
+201222817512
Fax 46230 0
Email 46230 0
[email protected]
Contact person for public queries
Name 46231 0
Mary Kamal Nassif Takla
Address 46231 0
Lecturer of Physical Therapy
School of Physical Therapy, Cairo University

Work address:7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 12612
Country 46231 0
Egypt
Phone 46231 0
+201222817512
Fax 46231 0
Email 46231 0
[email protected]
Contact person for scientific queries
Name 46232 0
Mary Kamal Nassif Takla
Address 46232 0
Lecturer of Physical Therapy
School of Physical Therapy, Cairo University

Work address:7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 12612
Country 46232 0
Egypt
Phone 46232 0
+201222817512
Fax 46232 0
Email 46232 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA comparison between different modes of real-time sonoelastography in visualizing myofascial trigger points in low back muscles2016https://doi.org/10.1179/2042618614y.0000000084
N.B. These documents automatically identified may not have been verified by the study sponsor.