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.

Abstract

OBJECTIVES:

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.

SETTING:

Pain Research center in an Urban Academic Rehabilitation Facility.

DESIGN:

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.

INTERVENTIONS:

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.

OUTCOME MEASURES:

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.

• Authors: R N Harden, T A Remble, T T Houle, J F Long, M S Markov, M A Gallizzi
• Journal: Pain practice : the official journal of World Institute of Pain (Pain Pract) Vol. 7 Issue 3 Pg. 248-55 (Sep 2007) ISSN: 1533-2500 [Electronic] United States
• PMID: 17714104 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Placebos

Topics

• Adult
• Aged
• Chronic Disease
• Electromagnetic Fields (adverse effects)
• Female
• Follow-Up Studies
• Humans
• Low Back Pain (epidemiology, physiopathology, therapy)
• Male
• Middle Aged
• Pain Measurement (methods)
• Pilot Projects
• Placebos
• Prospective Studies
• Single-Blind Method