Effectiveness of Magnetic Therapy on Pain Intensity

Phase

Condition

Post-surgical Pain

Pain

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT00104533

1753

1203-04-16295

Ages > 8
All Genders

Study Summary

Static magnetic therapy is increasingly used to alleviate pain; however, its efficacy has not been determined yet.

The aims of this proposal are to evaluate the effect of magnetic therapy on pain intensity levels, opioid requirements, and opioid side effects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Hospitalized or ambulatory patients 8 years old or older subjected to surgicalprocedures under general anesthesia, who reported at least moderate pain.

Exclusion

Exclusion Criteria:

Subjects with surgeries longer than 3 hours
Multiple surgical wounds
Back or craniofacial surgeries, or surgeries which required cast placement, bulkydressing or the implantation of metallic devices.
Subjects who did not understand the pain scales employed

Study Design

September 01, 2004

September 30, 2005

Study Description

Static magnetic therapy is increasingly used to alleviate pain; however, its efficacy has not been determined yet. The aims of this proposal are to evaluate the effect of magnetic therapy on pain intensity levels, opioid requirements, and opioid side effects.

A randomized, double blind, controlled trial is proposed. Patients from 8 years old and older subjected to a variety of surgical procedures with pain of intensity at least 5/10 will be randomized into two groups: Magnetic therapy or Placebo.

The devices will be placed around the surgical wound for 2 hours. Every ten minutes, patients will rate their pain intensity on a 0-10 numerical rating scale, and morphine will be administered until pain intensity is ≤ 4/10. Pain intensity will be the primary outcome. Opioid requirements and opioid side effects will be secondary outcomes.

To detect a difference of 1 unit (from 0 to 10) between the groups with 80% power, assuming that the baseline pain intensity is 7.9 ± 2.0, we estimated the need for 70 patients per group.

We will use an intention-to-treat analysis. To analyze the effect of the treatment on pain intensity, an analysis of repeated measures using generalized estimating equations will be used. The proportion of subjects in each group who exhibit 50% or more pain relief one hour after application of the magnetic devices and the number needed to treat will also be calculated. To analyze the effect of the treatment on opioid requirements, a difference in morphine requirements between groups two hours after placement of the magnets will be estimated. To analyze the effect of the treatment on opioid side effects, a variable that summarizes the presence of any side effect two hours after the placement of the magnets will be created, and the absolute risk difference for developing any side effect will be estimated. Ninety five percent confidence intervals will be reported.

This proposal would contribute substantially to the complementary medicine field, not only because of its scientific rigor, but also because the pain model that it evaluates strengthens the validity of the results.

Connect with a study center

San Ignacio Hospital
Bogota, DC
Colombia
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.