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.: PACTR202108838655474 Date of Approval: 16/08/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of extracorporeal shock wave therapy on chronic mechanical low back pain patients,randomized controlled trial.
Official scientific title Effect of extracorporeal shock wave therapy on pain intensity, pressure pain thershold, range of motion and functional disability in chronic mechanical low back pain patients
Brief summary describing the background and objectives of the trial Mechanical low back pain occurs at least once in 85 % of people younger than 40 years. MLBP is the most common and most expensive cause of work-related disability. MLBP is a serious health problem affecting people at some time in their life. It affects the mobility of the lumbar spine and adjacent joints leading to functional disability. Many types of low back pain are treated with therapeutic methods that are as diverse as the causes of low back pain. In most cases, therapeutic methods such as bed rest, assistive devices, traction treatment, hyperthermia, electric stimulation, and manual therapy are the first choice treatments. Recently, new conservative treatments have been adopted, including extracorporeal shock wave therapy (ESWT). ESWT is a therapeutic method that applies shock waves to lesions from the outside of the body to promote revascularization and to stimulate or reactivate the curing process of connective tissues including tendons and bones, thereby relieving pain and improving function. Currently, ESWT is administered for musculoskeletal system diseases, but studies of the effects of ESWT on chronic low back pain are rare. Purpose of the study: to measure the effect of extracorporeal shock wave therapy on pain intensity, pressure pain thershold, range of motion and functional disability in chronic mechanical low back pain patients. the patients of both gender with chronic mechanical low back pain will participate in the study with age ranging 20 to 40 years old. the patients will be assigned randomly into two equal groups A&B. pain intensity will be assessed by VAS. pressure pain threshold will be assessed by algometer, ROM will be assessed by inclinometer and functional disability will assessed by oswestry disability index.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ESWT ROM MLBP
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 01/04/2019
Actual trial start date 01/04/2019
Anticipated date of last follow up 01/06/2019
Actual Last follow-up date 15/06/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group conventional treatment program for chronic mechanical low back pain 12 sessions, twice session weekly. 6 weeks infrared radiation on lumbar area for 20 minutes, ultrasound waves for 5 minutes, TENS for 20 minutes and stretching and strengthening exercise for back and abdominal muscles. 30 Active-Treatment of Control Group
Experimental Group extracorporeal shock wave therapy on chronic mechanical low back pain 12 sessions, twice session weekly. 6 weeks extracorporeal shock wave therapy 2,000 shock wave impulses (5 Hz) on trigger points in back muscles , infrared radiation for 20 minutes, ultrasound waves for 5 minutes, TENS for 20 minutes and stretching and strengthening exercises for back and abdominal muscles. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients' age ranges from 20 to 40years old. • Patients are males and females. • BMI of all subjects were <30 Kg/m2. • Patients will be diagnosed as mechanical low back pain. • All patients are medically stable. • All patients should be conscious and ambulant. • Obese patients with BMI <30 Kg/m2. • Pregnant or lactating woman. • Spinal pathology that could refer pain to lower limbs. • History of spinal fracture. • Structural discrepancy as leg length discrepancy. • Cognitive impaired patients. • Patients with history of epilepsy. • Patients with cardiac pacemaker. Adult: 19 Year-44 Year 20 Year(s) 40 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 01/10/2017 faculty of physical therapy research ethics committee
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El-Zayat street Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome low back pain before treatment and after completion of sessions
Secondary Outcome pressure pain threshold before treatment and after completion of sessions
Secondary Outcome lumbar flexion range of motion before treatment and after completion of sessions
Secondary Outcome functional disability before treatment and after completion of sessions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
the clinic of Ahmed Maher Teaching Hospital 341, Portsaid St., Bab El Khalq cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal 23 Ali Hasan st. cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university 1 Gamaa Street Giza 12613 Egypt University
Primary Sponsor faculty of physical therapy 7 Ahmed El-zayat st.,Dokki Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Maher Ahmed Elkabalawy 7 Ahmed El-Zayat st.,Dokki Giza Egypt
Dr. Yasser Anis 7 Ahmed El-Zayat st.,Dokki Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maher Elkabalawy maher_ma2014@yahoo.com 01001419544 7 Ahmed El-Zayat st.,Dokki
City Postal code Country Position/Affiliation
Giza Egypt Professor of Physical Therapy for Basic Sciences
Role Name Email Phone Street address
Public Enquiries Yasser Anis dryasser_com@yahoo.com 01001743830 7 Ahmed El-Zayat st.,Dokki
City Postal code Country Position/Affiliation
Giza Egypt assisstant professor of physical therapy for basic sciences
Role Name Email Phone Street address
Scientific Enquiries Yasser Anis dryasser_com@yahoo.com 01001743830 7 Ahmed El-Zayat st.,Dokki
City Postal code Country Position/Affiliation
Giza Egypt assisstant professor of physical therapy for basic sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in chronic mechanical low back pain. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact clinicalresearchsupportcenter@ucdenver.edu.”
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