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Effects of PEMF on Pain Intensity Lower Back


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Open access
Protocol
Effects of pulsed low-frequency magnetic field therapy on pain intensity in patients with musculoskeletal chronic low back pain: study protocol for a randomised double-blind placebo- controlled trial
Fuad A Abdulla,1 Saad Alsaadi,1 MIR Sadat-Ali,2 Fahd Alkhamis,3 Hani Alkawaja,1 Serigne Lo4,5
To cite: Abdulla FA, Alsaadi S, Sadat-Ali MIR, et al. Effects of pulsed low-frequency magnetic field therapy on pain intensity in patients with musculoskeletal chronic low back pain: study protocol for a randomised double-blind placebo- controlled trial. BMJ Open 2019;9:e024650. doi:10.1136/ bmjopen-2018-024650
► Pre-publication history and additional material is published online only. To view please visit the journal online (http://dx.doi. org/10.1136/bmjopen-2018- 024650).
Received 6 June 2018 Revised 22 March 2019 Accepted 15 May 2019
AbstrACt
Introduction The aim of the present study is to investigate the effectiveness of pulsed low-frequency magnetic field (PLFMF) on the management of chronic low back pain (CLBP).
Methods and analysis A randomised double-blinded controlled clinical trial will be conducted, involving 200 patients with CLBP. Participants will be randomised in
a 1:1 ratio to receive either active PLFMF (experimental arm) or sham treatment (control arm) using a permuted- block design which will be stratified according to
three subtypes of musculoskeletal CLBP (nociceptive, peripheral neuropathic or central sanitisation). The intervention consists of three sessions/week for
6 weeks. The primary outcome is the percentage change in Numerical Rating Scale (NRS) pain at week 24 after treatment completion with respect to the baseline. Secondary outcomes include percentage NRS pain during treatment and early after treatment completion, short form 36 quality of life, Roland and Morris Disability Questionnaire; Depression Anxiety Stress Scale 21, Patient Specific Functional Scale, Global perceived effect of condition change, Pittsburgh Sleep Quality Index and Modified Fatigue Impact Scale. Measures
will be taken at baseline, 3 and 6 weeks during the intervention and 6, 12 and 24 weeks after completing the intervention. Adverse events between arms will be evaluated. Data will be analysed on an intention-to-treat basis.
Ethics and dissemination The study is funded by Imam Abdulrahman Bin Faisal University (IAU). It has been approved by the institutional review board of
IAU (IRB‐ 2017‐03–129). The study will be conducted
at King Fahd Hospital of the University and will be monitored by the Hospital monitoring office for research and research ethics. The trial is scheduled to begin in September 2018. Results obtained will be presented in international conferences and will be published in peer- reviewed journals.
trial registration number ACTRN12618000921280, prospectively.
strengths and limitations of this study
► The present study is a well-designed trial to inves- tigate the long-term efficacy and safety of pulsed low-frequency magnetic field (PLFMF) on the management of musculoskeletal chronic low back pain (LBP).
► Subgroup analysis investigating the efficacy of PLFMF on various subtypes of pain based on pain mechanism will be performed. This may help to explain controversial results reported by previous clinical trials.
► Outcome measures include various aspects of LBP problems (pain intensity as well as disabilities, func- tional limitations, sleep quality and quality of life).
► All outcome measures used in the present trial are self-report which may potentiate pain and other measured outcomes.
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
For numbered affiliations see end of article.
Correspondence to
Prof. Fuad A Abdulla; faabdullah@iau.edu.sa
IntroduCtIon
Chronic low back pain (CLBP) is a pain or discomfort localised in the lumbosacral region, with or without leg pain (sciatica) that persists for more than 3months.1 Eight out of every ten adults will experience low back pain (LBP) at least once in their life with more than 60% of such cases have a recur- rent LBP.2 Evidence suggests that LBP has a lifetime prevalence of 40%, and a mean point prevalence of 20%.3 The causes of LBP are many, they can range from simple spasm or mechanical causes to more serious causes such as herniated disc and different types of cancer.4 Symptoms of LBP may vary from one patient to another. In many patients, the symp- toms may go beyond pain to lead to severe consequences such as sleep disturbances, psychological and social problems which may
Abdulla FA, et al. BMJ Open 2019;9:e024650. doi:10.1136/bmjopen-2018-024650 1

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