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Effectiveness of Magnetic Therapy on Pain Intensity

This study has been completed.
Sponsor:
Information provided by:
Javeriana University
ClinicalTrials.gov Identifier:
NCT00104533
First received: March 1, 2005
Last updated: March 19, 2008
Last verified: March 2005
History of Changes
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
 Device: Magnets
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effectiveness of Magnetic Therapy on Pain Intensity

Further study details as provided by Javeriana University:

Primary Outcome Measures:
  • Pain intensity at rest

Secondary Outcome Measures:
  • Opioid requirements
  • Opioid side effects

Estimated Enrollment: 164
Study Start Date: September 2004
Study Completion Date: September 2005
Detailed 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.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects with surgeries longer than 3 hours
  • Multiple surgical wounds
  • Back or craniofacial surgeries, or surgeries which required cast placement, bulky dressing or the implantation of metallic devices.
  • Subjects who did not understand the pain scales employed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104533

Locations
Colombia
San Ignacio Hospital
Bogota, DC, Colombia
Sponsors and Collaborators
Javeriana University
Investigators
Principal Investigator: M. Soledad Cepeda, MD, PhD Javeriana University School of Medicine
  More Information

Additional Information:
Information about the study in Spanish  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00104533     History of Changes
Other Study ID Numbers: 1753, 1203-04-16295
Study First Received: March 1, 2005
Last Updated: March 19, 2008
Health Authority: Colombia: Institutional Review Board

Keywords provided by Javeriana University:
Static magnetic therapy
Pain
Analgesia
Opioids

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013