Table 1

Trial Registration Data Set

Data categoryInformation
Primary registry and trial identifying numberAustralian New Zealand Clinical Trial Registry ACTRN 12618000921280)
Date of registration in primary registry31/05/2018
Secondary identifying numbersIAU-2017–308-CAMS
Source(s) of monetary or material supportKing Fahd Hospital of the University
Primary sponsorImam Abdulrahman Bin Faisal University
Secondary sponsor(s)None
Contact for public queriesFuad A. Abdulla, PhD, PT
+966 13 3331308
faabdullah@iau.edu.sa
Contact for scientific queriesFuad A. Abdulla, PhD, PT
+966 13 3331308
faabdullah@iau.edu.sa
Public titleEffects of Pulsed Low Frequency Magnetic Field Therapy on Pain Intensity in Patients with Musculoskeletal Chronic Low Back Pain: A Randomised Double-Blind Placebo Controlled Trial
Scientific titleEffects of Pulsed Low Frequency Magnetic Field Therapy on Pain Intensity in Patients with Musculoskeletal Chronic Low Back Pain: A Randomised Double-Blind Placebo Controlled Trial
Countries of recruitmentSaudi Arabia
Health condition(s) or problem(s) studiedChronic Low Back Pain
Intervention(s)Active comparator: PLFMF, an average of 14 μT for 20 min) and the conventional physical therapy programme (three times per week for 6 weeks)
Placebo comparator: sham PLFMF (the machine will not be activated, ie, no magnetic field will be generated, for 20 min) and the conventional physical therapy programme (three times per week for 6 weeks)
The conventional physical therapy programme consists of:
· Hot packs for 20 min
· Back, hamstring and calf muscles stretching (performed from the long sitting position)
· Lumbar erector spinae muscles self-stretching
· Back muscles strengthening (back extension and bridging)
· Abdominal muscles strengthening (posterior pelvic tilt and sit-ups)
Participants will be asked to hold the above positions for 5 s. Each exercise will be done five times per session with 1 min rest between any two repetitions
Key inclusion and exclusion criteriaAges eligible for study: 18–60 years
Sexes eligible for study: both
Accepts healthy volunteers: no
Inclusion criteria:
· Clinical evidence of musculoskeletal chronic low back pain including subtype classification (nociceptive vs peripheral neuropathic vs central sanitization)
· Age 18–60 years old
· Primary complaint of pain (at least a score of 5 out of 10 on a 0–10 NRS) in the area between the 12th rib and buttock crease, with or without leg pain for 3 months or more
Exclusion criteria:
· Pregnant or lactating
· Significant spinal pathology (eg, spinal fracture, cauda equina syndrome, spinal infective or inflammatory diseases, metastatic)
· Spinal surgery within the preceding 6 months
· Recent organ transplants
· Heart pacemaker
· Cardiac arrhythmia, tachycardia conditions or large aneurysm
· Heavy psychosis
· Epileptic episodes
Study typeInterventional
Allocation: randomised
Allocation concealment: sealed opaque envelopes
Sequence generation: permuted-block randomization
Intervention model: parallel assignment
Masking: double-blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose: treatment
Date of first enrolmentSeptember 2018
Target sample size200
Recruitment statusWill begin Recruiting in July
Primary outcome(s)The percentage change in pain intensity by calculating the percentage change in NRS of pain.
The percentage change in pain will be calculated at each post-baseline assessment as:
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All patients will be evaluated at baseline, end of the third and the sixth week from the beginning of the intervention. To assess for effects persistence, participants will be also evaluated at 6 weeks, 12 weeks and 24 weeks after the end of the intervention sessions
Key secondary outcomesa. Quality of life assessed using Short Form 36 quality of life questionnaire. Time points: baseline, end of the third and the sixth week from the beginning of the intervention. 6 weeks, 12 weeks and 24 weeks after the end of the intervention sessions
b. Disability assessed by the Roland and Morris Disability Questionnaire. Time points: baseline, end of the third and the sixth week from the beginning of intervention. 6 weeks, 12 weeks and 24 weeks after the end of the intervention sessions
c. Depression, anxiety and stress assessed by Depression Anxiety Stress Scale 21 questionnaire. Time points: baseline, end of the third and the sixth week from the beginning of the intervention. 6 weeks, 12 weeks and 24 weeks after the end of the intervention sessions
d. Function measurement assessed by the Patient Specific Functional Scale. Time points: baseline, end of the third and the sixth week from the beginning of the intervention. 6 weeks, 12 weeks and 24 weeks after the end of the intervention sessions
e. Change in condition assessed by Global perceived effect of condition change. Time points: baseline, end of the third and the sixth week from the beginning of the intervention. 6 weeks, 12 weeks and 24 weeks after the end of the intervention sessions
f. Quality of sleep assessed by the Pittsburgh Sleep Quality Index. Time points: baseline, end of the third and the sixth week from the beginning of the intervention. 6 weeks, 12 weeks and 24 weeks after the end of the intervention sessions
g. Fatigue assessed by Modified Fatigue Impact Scale. Time points: baseline, end of the third and the sixth week from the beginning of the intervention. 6 weeks, 12 weeks and 24 weeks after the end of the intervention sessions
  • NRS, Numerical Rating Scale; PLFMF, pulsed low frequency  magnetic field.