Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201402000761317 Date of Approval: 03/02/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A COMPARSION BETWEEN DIFFERENT MODES OF REAL-TIME SONOELASTOGRAPHY IN VISUALIZING MYOFASCIAL TRIGGER POINTS IN LOW BACK MUSCLES
Official scientific title A COMPARSION BETWEEN DIFFERENT MODES OF REAL-TIME SONOELASTOGRAPHY IN VISUALIZING MYOFASCIAL TRIGGER POINTS IN LOW BACK MUSCLES
Brief summary describing the background and objectives of the trial Myofascial pain syndrome (MPS) is a major myalgic progenitor, affecting every age group. It constitutes one of the most important chronic problems encountered in clinical practice, with a prevalence as high as 85% to 93% of patients presenting to pain management centers. The core of this syndrome is the myofascial trigger points (MTrPs), which are hyperirritable nodules found within skeletal muscles, located in taut bands of muscle fibers. MTrPs can be either active or latent; an active MTrP (A-MTrP) refers pain either locally to a large area and/or to other remote location, initiating the peripheral pain found in generalized musculoskeletal pain disorders. The root of the difficulty in the diagnosis of MPS; that remains highly debated, despite the presence of criteria, lies in their difficult-to-quantitate 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.Purpose: To compare (1) MTrPs and surrounding myofascial tissue by real-time 2-dimensional grey scale ultrasound and vibration sonoelastography (VSE); (2) the 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.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Myofasical trigger points
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 03/01/2011
Actual trial start date 16/06/2011
Anticipated date of last follow up 04/07/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
2013/03/05 Cairo University president approval
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Non-randomised Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Real-time sonoelastography on active myofascial trigger points Once One time Diagnostic imaging procedure 25
Experimental Group Real-time sonoelastography on latent myofascial trigger points Once One time diagnostic imaging procedure 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be included in the study, the 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. Subjects with Latent-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 as cervical pain and tennis elbow. Normal (20-24.9) and overweight (25-29.9) body mass index subjects were included in the study. active rheumatoid arthritis fractures and structural deformities of trunk, hip, knee and ankle joints neurological symptoms disc prolapse previous spinal surgery pregnancy body mass index of class II to III. 25 Year(s) 45 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/01/2011 Faculty of Physical Therapy Council
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza Giza 12612 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/03/2013 Ministry of Higher Education: Higher education council of Cairo University
Ethics Committee Address
Street address City Postal code Country
Cairo University Rd, Oula, Giza Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Vibration sonoelastography tissue strain Only once, after the assessment and clinical identification of myofascial trigger points by palpation
Primary Outcome 2-Dimensional grey scale ultrasound to assess echogenicity of myofascial trigger points Only once, after the assessment and clinical identification of myofascial trigger points by palpation
Secondary Outcome Vibration sonoelastography colored image Only once, after the assessment and clinical identification of myofascial trigger points by palpation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy, Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University, Faculty of Pysical therapy 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza Giza 12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy, Cairo University 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mary Kamal Nassif Takla 7 nabil el wakad street, el marwa building, naser city Cairo 11341 Egypt
Omaima Kattabei 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza GIZA 12612 Egypt
. Naglaa Mohamed Abdel Razek Kasr Al Ainy St. Cairo, Giza 11562 Egypt
Marzouk Abdel Fattah El-Lythy 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza Giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mary Takla marytakla@hotmail.com 00201222817512 7 Nabil el wakad street, El marwa buildings, Naser city
City Postal code Country Position/Affiliation
Cairo 11341 Egypt Lecturer of Physical Therapy, Cairo University
Role Name Email Phone Street address
Public Enquiries Mary Takla marytakla@hotmail.com 00201222817512 7 Nabil el wakad street, el marwa buildings, Naser city
City Postal code Country Position/Affiliation
Egypt
Role Name Email Phone Street address
Scientific Enquiries Mary Takla marytakla@hotmail.com 00201222817512
City Postal code Country Position/Affiliation
Egypt
REPORTING
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