Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201805003393380 Date of Approval: 18/05/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Pulsed Electromagnetic Field on nonspecific low back pain patients
Official scientific title Effect of Pulsed Electromagnetic Field on nonspecific low back pain patients: A randomized controlled trial
Brief summary describing the background and objectives of the trial Background: Further research on pulsed electromagnetic field (PEMF) effects on the different conditions of low back pain was warranted due to lack of studies in this area. Objectives:To investigate the effects of pulsed electromagnetic field therapy with50 Hz frequency, with low intensity of 20 gauss compared to conventionalnon-invasive treatment modalities in patients with chronic non-specific low back pain..Design:A prospective, randomized, single-blind, pre¿post-test, controlled trial.Setting: The study was conducted at Outpatient Physiotherapy Clinic in Cairo, Egypt. The study was conducted between May 2015 and September 2016.Participants: Fifty participants with non-specific low back pain enrolled into experimental and control groups. Interventions: The experimental group received the Conventional physical therapy Protocol as well as magnetic field, while the control group received the same Conventional physical therapy and sham electromagnetic field. Both group received 12 sessions over four weeks¿ period.Outcome measures: Primaryoutcome measureswas pain severity while the secondary outcome measure was functional disability, lumbar range of motion (flexion, extension, right side bending and left side bending).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Non specific low back pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 03/05/2015
Actual trial start date 19/05/2015
Anticipated date of last follow up 18/09/2016
Actual Last follow-up date 23/09/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known P.T.REC/012/00422
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 Anonymity was assured through coding of all data. They were randomly allocated into experimental and control treatment group by a blinded and an independent research assistant who opened sealed envelopes that contained a computer generated randomization card. Anonymity was assured through coding of all data. They were randomly allocated into experimental and control treatment group by a blinded and an independent research assistant who opened sealed envelopes that contained a computer generated randomization card. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional physical therapy Protocol 12 sessions over a four-week period received the same Conventional physical therapy and sham electromagnetic field. 25 Placebo
Experimental Group experimental group received the Conventional physical therapy Protocol as well as magnetic field 12 sessions over a four-week period TENS therapy for the low back (15 minutes 3 days/week), with a frequency of 100 Hz and fixed pulse12. Ultrasonic for 5 minutes, 1Hz, continuous mode of application 1.5w/cm213. The exercise programs were individually designed based on the patient examination and the clinical findings. ASA magnetic field device (Automatic PMT Quattro pro) with frequency of 50 Hz. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
, the participants were diagnosed clinically with chronic non-specific low back painby the neurologist. The participants' ages ranged from 20 to 40 years, had low back pain for more than 3 months ago, with a Visual analogue scale (VAS) Pain score>4. if they were Pregnant or lactating women, had history of previous back surgery, Radicular pain, Current lower extremity symptoms, Cardiopulmonary disease with decreased activity tolerance, open wound in the treated area, cauda equina symptoms or the known presence of tumor, any participation in a clinical trial or physical therapy treatmentwithin the past 30 days 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 18/01/2015 the institutional review board at Faculty of physical therapy, Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elziat Street, Bean Elsariat, El Dokki, Giza, Egypt. Giza 12625 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome subjective pain sensation was assessed by scoring in the 10-point visual analogue rating scale, zero indicates no pain while 10 represents the worst pain4 before and after one month
Secondary Outcome functional disability, lumbar range of motion (flexion, extension, right side bending and left side bending) before and after one month of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Out Clinic of Faculty of Physical Therapy, Cairo University 7 Ahmed Elziat Street, Bean Elsariat, El Dokki, Giza, Egypt. Giza 12625 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of physical therapy 7 Ahmed Elziat Street, Bean Elsariat, El Dokki, Giza, Egypt. Giza 12625 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hamada Ahmed Hamada 7 Ahmed Elziat Street, Bean Elsariat, El Dokki, Giza, Egypt. Giza 12625 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Mohamed Elshiwi 7 Ahmed Elziat Street, Bean Elsariat, El Dokki, Giza, Egypt. Giza Egypt
Dalia Mosaad 7 Ahmed Elziat Street, Bean Elsariat, El Dokki, Giza, Egypt. Giza Egypt
Ibrahim Ragab Beni-Suef Egypt
Ghada Mohamed Koura Giza Egypt
Saud Mashi Alrawaili College of Applied Medical Sciences, Prince Sattam, Bin Abdulaziz University, KSA Saudi Arabia
Hamada Ahmed Hamada 7 Ahmed Elziat Street, Bean Elsariat, El Dokki, Giza, Egypt. Giza 12625 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hamada Ahmed hamada.ahmed@pt.cu.edu.eg 00201117893697 7 Ahmed Elziat Street, Bean Elsariat, El Dokki, Giza, Egypt.
City Postal code Country Position/Affiliation
Giza 12625 Egypt lLecturer of Biomechanics, Faculty of Physical Therapy, Cairo University
Role Name Email Phone Street address
Public Enquiries hamada Ahmed hamada.ahmed@pt.cu.edu.eg 00201117893697 7 Ahmed Elziat Street, Bean Elsariat, El Dokki, Giza, Egypt.
City Postal code Country Position/Affiliation
Giza 12625 Egypt lecturer of Biomechanics, Faculty of Physical Therapy, Cairo Universit
Role Name Email Phone Street address
Scientific Enquiries hamada Ahmed hamada.ahmed@pt.cu.edu.eg 00201117893697 7 Ahmed Elziat Street, Bean Elsariat, El Dokki, Giza, Egypt.
City Postal code Country Position/Affiliation
Giza 12625 Egypt lecturer of Biomechanics, Faculty of Physical Therapy, Cairo Universit
REPORTING
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