Double-blind placebo-controlled trial of static magnets for the treatment of osteoarthritis of the knee: Results of a pilot study
Outpatient clinical studies of magnet therapy, a complementary therapy commonly used to treat osteoarthritis (OA), have been limited by the absence of a credible placebo control.
Our objective was to assess the feasibility and promise of studying static magnetic therapy for knee OA and determine the ability of a new placebo-magnet device to provide concealment of group assignment.
Randomized, double-blind, placebo-controlled clinical trial.
Academic teaching hospital in Boston.
We enrolled 29 subjects with idiopathic or post-traumatic OA of the knee.
Subjects received either high-strength magnetic (active) or placebo-magnetic (placebo) knee sleeve treatment for 4 hours in a monitored setting and self-treatment 6 hours daily for 6 weeks.
Primary outcomes were change in knee pain as measured by the WOMAC Osteoarthritis Index Pain Subscale at 6 weeks and extent of group concealment at study end.
At 4 hours, VAS pain scores (+/- SE) on a 5-item scale (0-500, 500 worst) decreased 79 +/- 18 mm in the active group and 10 +/- 21 mm in the placebo group (P < 0.05). There were no significant differences in any primary or secondary measure of efficacy between the treatment groups at 6 weeks. Despite widespread testing for magnetic properties, at study end, 69% of the active group and 77% of the placebo group (P > 0.2) believed that they had been assigned to the active treatment group.
Despite our small sample size, magnets showed statistically significant efficacy compared to placebo after 4 hours under rigorously controlled conditions. The sustained efficacy of magnetic therapy for knee osteoarthritis could be assessed in an adequately powered trial utilizing an appropriate control such our new placebo-magnet device.
Available from: Jane M Blazeby
- "In pharmacological trials, it is common to use a matched placebo to blind staff and patients. In the case of surgical trials, however, using a placebo or sham surgery is often difficult or impossible because it may be considered unethical to subject patients to general anaesthesia and a mock operation for solely research purposes, although such examples exist [45–51]. The complex nature of surgery can also make blinding of staff difficult because of the necessity for input from a large multidisciplinary team and it is frequently impossible for surgeons to be blinded because of their role in delivery of the intervention. "
[Show abstract] [Hide abstract]
ABSTRACT: Randomised controlled trials (RCTs) in surgery are complex to design and conduct and face unique challenges compared to trials in other specialties. The appropriate selection, measurement and reporting of outcomes are one aspect that requires attention. Outcomes in surgical RCTs are often ill-defined, inconsistent and at high risk of bias in their assessment and historically, there has been an undue focus on short-term outcomes and adverse events meaning the value of trial results for clinical practice and decision-making is limited.
This review addresses three key problems with surgical trial outcomes-choosing the right outcomes for the trial design and purpose, selecting relevant outcomes to measure from the range of possible outcomes, and measuring outcomes with minimal risk of bias. Each obstacle is discussed in turn, highlighting some suggested solutions and current initiatives working towards improvements in these areas. Some examples of good practice in this field are also discussed.
Many of the historical problems with surgical trial outcomes may be overcome with an increased understanding of the trial design and purpose and recognition that pragmatic trials require assessments of outcomes that are patient-centred in addition to measurement of short-term outcomes. The use of core outcome sets developed for specific surgical interventions and the application of novel methods to blind outcome assessors will also improve outcome measurement and reporting. It is recommended that surgeons work together with trial methodologists to integrate these approaches into RCTs in surgery. This will facilitate the appropriate evaluation of surgical interventions with informative outcomes so that results from trials can be useful for clinical practice.
Langenbeck s Archives of Surgery 11/2013; 399(3). DOI:10.1007/s00423-013-1136-8 · 2.19 Impact Factor
Available from: Sanjay Kumar
- "In fact, many medical devices used in medical therapies generate circulating currents that trigger cellular, hormonal, and behavioral responses. Wolsko et al44 demonstrated that PEMF relieves or eliminates pain through a mechanism mediated by Ca2+ ion channels. Luo et al45 found that metal ions are necessary for enzymatic activity, and, thus, pulsed electromagnetic field are able to influence the catalytic activities of enzymes. "
[Show abstract] [Hide abstract]
ABSTRACT: Environmental exposure to man-made electromagnetic fields has been steadily increasing with the growing demand for electronic items that are operational at various frequencies. Testicular function is particularly susceptible to radiation emitted by electromagnetic fields.
This study aimed to examine the therapeutic effects of a pulsed electromagnetic field (100 Hz) on the reproductive systems of male Wistar rats (70 days old).
The experiments were divided into five groups: microwave sham, microwave exposure (2.45 GHz), pulsed electromagnetic field sham, pulsed electromagnetic field (100 Hz) exposure, and microwave/pulsed electromagnetic field exposure. The animals were exposed for 2 hours/day for 60 days. After exposure, the animals were sacrificed, their sperm was used for creatine and caspase assays, and their serum was used for melatonin and testosterone assays.
The results showed significant increases in caspase and creatine kinase and significant decreases in testosterone and melatonin in the exposed groups. This finding emphasizes that reactive oxygen species (a potential inducer of cancer) are the primary cause of DNA damage. However, pulsed electromagnetic field exposure relieves the effect of microwave exposure by inducing Faraday currents.
Electromagnetic fields are recognized as hazards that affect testicular function by generating reactive oxygen species and reduce the bioavailability of androgen to maturing spermatozoa. Thus, microwave exposure adversely affects male fertility, whereas pulsed electromagnetic field therapy is a non-invasive, simple technique that can be used as a scavenger agent to combat oxidative stress.
Clinics (São Paulo, Brazil) 07/2011; 66(7):1237-45. DOI:10.1590/S1807-59322011000700020 · 1.19 Impact Factor
Available from: ncbi.nlm.nih.gov
BMJ Clinical Research 12/2004; 329(7480). DOI:10.1136/bmj.329.7480.1454 · 14.09 Impact Factor
Data provided are for informational purposes only. Although carefully collected, accuracy cannot be guaranteed. The impact factor represents a rough estimation of the journal's impact factor and does not reflect the actual current impact factor. Publisher conditions are provided by RoMEO. Differing provisions from the publisher's actual policy or licence agreement may be applicable.