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Table 1 Trial Registration Data Set
Data category
Information
Primary registry and trial identifying number
Australian New Zealand Clinical Trial Registry ACTRN 12618000921280)
Date of registration in primary registry
31/05/2018
Secondary identifying numbers
IAU-2017–308-CAMS
Source(s) of monetary or material support
King Fahd Hospital of the University
Primary sponsor
Imam Abdulrahman Bin Faisal University
Secondary sponsor(s)
None
Contact for public queries
Fuad A. Abdulla, PhD, PT +966 13 3331308 faabdullah@iau.edu.sa
Contact for scientific queries
Fuad A. Abdulla, PhD, PT +966 13 3331308 faabdullah@iau.edu.sa
Public title
Effects 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 title
Effects 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 recruitment
Saudi Arabia
Health condition(s) or problem(s) studied
Chronic 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 6weeks)
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 20min
• 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 1min rest between any two repetitions
Key inclusion and exclusion criteria
Ages eligible for study: 18–60years 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 18–60years 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 type
Interventional
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
Continued
4 Abdulla FA, et al. BMJ Open 2019;9:e024650. doi:10.1136/bmjopen-2018-024650
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