Prospective, randomized, single-blind, sham treatment-controlled study of the safety and efficacy of an electromagnetic field device for the treatment of chronic low back pain: a pilot study.
OBJECTIVE
To evaluate the efficacy and safety of therapeutic electromagnetic fields (TEMF) on chronic low back pain. Secondary objectives included the investigation of the effects of TEMF on psychometric measures.


METHODS
Pain Research center in an Urban Academic Rehabilitation Facility.


METHODS
Prospective, randomized, single-blind, placebo (sham) treatment-controlled design in which participants were evaluated over a 6-week period. A total of 40 subjects were randomly assigned: 20 subjects to 15 milliTESLA (mT) treatment using a prototype electromagnetic field device and 20 to sham treatment.


METHODS
After a 2-week baseline period, eligible individuals were randomized to one of the treatment groups (sham or 15 mT) for six 30-minute treatments over 2 weeks, then a 2-week follow-up period.


METHODS
The primary outcome measure was the self-report of pain severity using a 100 mm visual analog scale collected using a twice daily McGill Pain Questionnaire-Short Form. Several secondary measures were assessed.


RESULTS
Both groups (15 mT and sham) improved over time (P < 0.05). Although groups were similar during the treatment period, treated subjects (TEMF of 15 mT) improved significantly over sham treatment during the 2-week follow-up period (20.5% reduction in pain; F(1,34) = 10.62, P = 0.003). There were no reported serious adverse events.


CONCLUSIONS
This study demonstrates that TEMF may be an effective and safe modality for the treatment of chronic low back pain disorders. More studies are needed to test this hypothesis.
Harden
R N
RN
Center for Pain Studies, Chicago, Illinois 60611, USA. nharden@ric.org
Remble
T A
TA
Houle
T T
TT
Long
J F
JF
Markov
M S
MS
Gallizzi
M A
MA
D000328:Adult; D000368:Aged; D002908:Chronic Disease; D004574:Electromagnetic Fields / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017116:Low Back Pain / Q000453:epidemiology / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000379:methods; D010865:Pilot Projects; D010919:Placebos; D011446:Prospective Studies; D016037:Single-Blind Method
D010919:Placebos