None listed
Conditions
Brief summary
Chronic low back pain (CLBP) is a major reason for disability world-wide. Available interventions for CLBP are short lived for the majority of the cases. The search for safe, non-invasive and cost-effective approaches is under way. The aim of the present study is to investigate the effectiveness of pulsed low frequency magnetic field (PLFMF) on the management of CLBP. A randomized double blinded control trial will be conducted, involving two hundred patients with various subtypes of musculoskeletal CLBP. Patients will be recruited from King Fahd Hospital of the University. Participants will be will be divided randomly in a 1:1 ratio to receive either active PLFMF (experimental arm, participants will receive pulsed low frequency magnetic field and the conventional physical therapy program) or sham treatment (control arm, participants will not receive pulsed low frequency magnetic field but will receive the conventional physical therapy program) using a permuted-block design which will be stratified according to three subtypes of musculoskeletal CLBP (nociceptive, peripheral neuropathic or central sanitization). The study treatment consists of 3 sessions/week for over 6 weeks in both the intervention and the control arms. The primary outcome is defined as the percentage reduction in Numeric Rating Scale (NRS, measure pain intensity) pain at week-24 after treatment completion with respect to baseline score. Secondary outcomes includes percentage NRS pain during treatment and early after treatment completion, short form 36 of quality of life (measure quality of life), disability measurement using the Roland and Morris Disability Questionnaire; Depression Anxiety Stress Scale 21 (to measure depression, anxiety and stress), function measurement using Patient Specific Functional Scale, Global perceived effect of condition change, Pittsburgh Sleep Quality Index to measure sleep quality and Modified Fatigue Impact scale to assess the fatigue level. Measures will be taken at baseline, 3 and 6 weeks after the beginning of intervention and 6, 12 and 24 weeks after trial completion. Adverse events between arms will be evaluated. This randomized trial is powered to assess the effectiveness of long-term efficacy and safety of PLFMF on the management of CLBP.
Interventions
This is a two-arm randomized, double blind, placebo controlled clinical trial. The trial will be conducted at the department of physical therapy of King Fahd Hospital of the University. King Fahd Hospital of the University is an 800 beds teaching hospital located at the Eastern Province of the Kingdom of Saudi Arabia. All researchers are clinicians at the departments of physical therapy and orthopedics. All participants will be recruited from the Hospital. All screening, interventions and evalu
This is a two-arm randomized, double blind, placebo controlled clinical trial. The trial will be conducted at the department of physical therapy of King Fahd Hospital of the University. King Fahd Hospital of the University is an 800 beds teaching hospital located at the Eastern Province of the Kingdom of Saudi Arabia. All researchers are clinicians at the departments of physical therapy and orthopedics. All participants will be recruited from the Hospital. All screening, interventions and evaluation will be done by qualified musculoskeletal physical therapists who have 5 or more years of clinical experience. Each participant will be assigned randomly to either the experimental group which will receive Pulsed Low Frequency Magnetic Field Therapy (PLFMF) and the conventional physical therapy program or the control group which will receive sham PLFMF and the conventional physical therapy program. Patients will be asked to lie down on the magnetic mattress for 20 minutes/session, three sessions a week for a total of 18 sessions (6 weeks). Each session (intervention or placebo) will last for 60 minutes as follows: 20 minutes for active PLFMF or placebo followed by 20 minutes for hot packs covering the lower back area and 20 minutes for exercises respectively. In the treatment group, the BEMER mattress will be activated whereas in the control group (placebo), no magnetic field will be generated. The conventional physical therapy program consists of: • Hot packs for 20 minutes; • Back, hamstring and calf muscles stretching (performed from long setting 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 seconds. Each exercise will be done 5 times per session with 1 minute rest between any two repetitions. The BEMER 3000 (BEMER Int. AG) will be used to deliver PLFMF (the machine will be pre-programmed with an average intensity of 14 µT). The signal comprises of a series of half-wave-shaped sinusoidal intensity variations. The signal which starts with low values slowly increases and then decreases but it does not go back to the initial value (i.e. stay above zero). The intensity will gradually get denser with the repetition of the sequence leading to an increase in the ups and downs with repetition. Every second this procedure will be repeated 33.3 times with a reversal of polarity every 2 minutes. Trial staff will monitor adherence to the either treatment sessions through session attendance.
Sponsors
Deanship of Research, Imam Abdulrahman Bin Faisal University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
• Clinical evidence of musculoskeletal chronic low back pain including subtype classification (nociceptive versus peripheral neuropathic versus central sanitization); • Age 18-60 years old; • Primary complaint of pain (at least a score of 5 out of 10 on a 0- 10 numerical rating scale) 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 (e.g. spinal fracture, cauda equina syndrome, spinal infective or inflammatory diseases, , metastatic); • Spinal surgery within the preceding 6 months; • Recent organ transplants. • Heart pace maker. • Cardiac arrhythmia, tachycardia conditions or large aneurysm. • Heavy psychosis. • Epileptic episodes.
Outcome results
None listed