Are ionized wrist bracelets better than placebo for musculoskeletal pain?

Journal of Family Practice, March, 2003 by Kodavayour S. Nirmal, Kendra Schwartz

Bratton R, Montero D, Adams K, et al. Effect of "ionized" wrist bracelets on musculoskeletal pain; A randomized, double-blind, placebo-controlled trial. Mayo Clin Proc 2002; 77:1164-1168.

* PRACTICE RECOMMENDATIONS

As a result of a profound placebo effect, this study showed that Q-Ray ionized wrist bracelets were not superior to placebo bracelets in self-reported pain improvement among patients with musculoskeletal pain,

Like many other studies involving the treatment of pain, the perception that the treatment would work profoundly improved its effectiveness. While the bracelet did not work better than placebo, many patients may experience less pain if they purchase and use it.

* BACKGROUND

Currently, there are advertisements claiming that this ionized bracelet relieves musculoskeletal pain. This study compared the efficacy of ionized wrist bracelets and identical placebo wrist bracelets in treating musculoskeletal pain.

* POPULATION STUDIED

The researchers studied a group of 610 adults (recruited from advertisements posted at the Jacksonville, Florida Mayo Clinic) with pain in at least 1 of 12 locations: neck, shoulders, elbows, wrists, hands, upper back, mid back, lower back, hips, knees, ankles, or feet. The mean age of the participants was 48 years; most were female (74.2%) and white (87.8%). Similar numbers of participants in both treatment groups had previously used ionized bracelets (4.5%), and about 80% believed the ionized bracelet would work.

* STUDY DESIGN AND VALIDITY

The study was a randomized, placebo-controlled trial. Patients, researchers, and the bracelet manufacturer were blinded to the identity of the bracelets. Allocation was concealed during enrollment. The patients were randomly assigned to wear the ionized wrist bracelet or an identical placebo bracelet for 4 weeks. Patients wore the bracelets according to manufacturer's instructions. All 610 patients completed the study.

The project was well designed. Identical bracelets were provided by the same manufacturer. All of those who might have been biased in their assessment of effect had they known the identity of the bracelets were blinded to treatment assignment.

There are, however, several factors limiting the generalizability of the results to primary care patients. First, study participants were mostly middle-aged, white women recruited in a tertiary care center who believed that ionized bracelets work. Second, although similar percentages in both treatment groups reported pain and injury at specific locations, the duration and cause of pain were not disclosed. Additionally, the authors did not provide a discussion of the power calculation for the sample size necessary to find a difference if one existed.

* OUTCOMES MEASURED

The authors measured 2 primary endpoints. The first was the change in pain score on a 10-point scale at 4-week follow-up at the location where baseline pain was most severe. The second endpoint was change in the sum total of pain scores for all locations after 4 weeks of bracelet use.

* RESULTS

There was no significant difference between the 2 groups for either endpoint. The baseline pain score for all body locations for both groups was between 4.2 and 5.8 out of a possible 10; at 4-week follow-up the scores had decreased 1.3 to 2.6 points. Most (77%) individuals in both groups reported improvement in their maximum pain score and a similar percentage had an improved sum of pain scores.

Kodavayour S. Nirmal, MD, and Kendra Schwartz, MD, MSPH, Department of Family Medicine, Wayne State University, Detroit, Mich. E-mail: ksnirmal@med.wayne.edu.