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.: PACTR201907878425407 Date of Approval: 12/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of extracorporeal shock wave therapy on electromyographic activity of trunk muscles in non specific chronic low back pain
Official scientific title Effect of extracorporeal shock wave therapy on electromyographic activity of trunk muscles in non specific chronic low back pain
Brief summary describing the background and objectives of the trial It is found that low back pain one of a major medical and socioeconomic problem among working populations in industrialized countries negatively affecting worker’s quality of life and productivity. Extracorporeal shock wave therapy (ESWT) can be used for pain relief as well as improving muscle strength through appropriate motor simulation of the muscles and tendons with extracorporeal shockwaves .so in this study there is need to to evaluate the effect of ESWT on electromyographic activity of trunk muscles in non specific chronic low back pain patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 20/09/2019
Actual trial start date 01/10/2019
Anticipated date of last follow up 01/02/2020
Actual Last follow-up date 01/04/2020
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group shock wave treatment pgrogram Fifteen patients will receive conventional treatment program plus ESWT for patients twice per week for six weeks twice \ week for two months With the patients in a prone position, 2,000 (7 times per sec) shockwave impulses (5 Hz) at an energy flux density of 0.10 mJ/mm2 will be delivered using a 17-mm head. After determining the regions of low back pain through physical examinations. the treated regions will be mainly the quadratus lumborum muscle, the gluteus maximus muscle, the gluteus medius muscle, the gluteus minimus muscle, and the piriform muscle that will be determined by palpation 15
Control Group conventional treatment pfrogram twice \ week two months15 Manual passive stretching exercises for hamstrings, iliopsoas, and back extensors will be performed from supine, prone, and cross-sitting positions, respectively. Each stretching position will be maintained for 30 seconds and will be repeated 3 times per session . Progressive strengthening exercises will be applied for the abdominal and back extensors from crook lying and prone positions, respectively. The conventional program will be applied twice per week for six weeks 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients with age range from 20-30 years old from both genders • • Patients with BMI normal values (18.5 - 24.9) • Patients with CLBP without specific pathology. • Patients with pain symptoms lasting more than 3 months. • Patients who are pregnant. • Patients have previous surgery for lumber region. • Patients with history of pathology of spine as Spondylosis, spondylolisthesis, spine tumours, cauda equine syndrome or spinal infection. • Patients with inflammatory diseases such as rheumatism Adult: 19 Year-44 Year 20 Year(s) 33 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 02/12/2018 Cairo University Faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
cairo University Faculty of physical therapy eldoky street cairo 20002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome will be measured before applying intervention for two months before intervention which will be applied for two months
Secondary Outcome EMG activity of trunk muscles - pain level and functional activity will be measured after applying intervention for two months after two months after applying intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Cairo University cairo cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hussieny mohamed Cairo Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hussieny Mohamed Ali El-sharkia -Faqous Zagazig Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mohamed Elgendy Cairo Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed elgendy Prof.mgendy@hotmail.com +201005747169 cairo
City Postal code Country Position/Affiliation
cairo Egypt professor and Head of the Basics science department in physical therapy faculty
Role Name Email Phone Street address
Scientific Enquiries Hisham Mohamed Hussien Drhisham3000@cu.edu.eg +201020936303 cairo
City Postal code Country Position/Affiliation
cairo Egypt lecturer of Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries mai hussieny drmdm66@yahoo.com +201023334897 cairo
City Postal code Country Position/Affiliation
cairo Egypt lecturer assistant faculty of physical therapy HUE unveristy in Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes age -body weight - height- BMI (body mass index)- clinilcal condition functioal level by Oswestery Disability index (ODI) - pain level by visual analogue sclae (VAS) and electromyographic activity will be measured by Surface EMG will be reported for all participants Clinical Study Report,Informed Consent Form,Study Protocol at 1 april 2020 controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information