Effectiveness of Magnetic Therapy on Pain Intensity
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 3
Locations
Colombia
Study Type
Interventional
Intervention
Magnets
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Static magnetic therapy, Pain, Analgesia, Opioids
Eligibility 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
Sites / Locations
- San Ignacio Hospital
Outcomes
Primary Outcome Measures
Pain intensity at rest
Secondary Outcome Measures
Opioid requirements
Opioid side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00104533
Brief Title
Effectiveness of Magnetic Therapy on Pain Intensity
Official Title
Effectiveness of Magnetic Therapy on Pain Intensity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Javeriana University
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Static magnetic therapy, Pain, Analgesia, Opioids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
164 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Magnets
Primary Outcome Measure Information:
Title
Pain intensity at rest
Secondary Outcome Measure Information:
Title
Opioid requirements
Title
Opioid side effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Soledad Cepeda, MD, PhD
Organizational Affiliation
Javeriana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Ignacio Hospital
City
Bogota
State/Province
DC
Country
Colombia
12. IPD Sharing Statement
Citations:
PubMed Identifier
17242082
Citation
Cepeda MS, Carr DB, Sarquis T, Miranda N, Garcia RJ, Zarate C. Static magnetic therapy does not decrease pain or opioid requirements: a randomized double-blind trial. Anesth Analg. 2007 Feb;104(2):290-4. doi: 10.1213/01.ane.0000230613.25754.08.
Results Reference
result
Links:
URL
http://portal2.javeriana.edu.co/psp/eppro/OFI/EMPL/h/?tab=DEFAULT
Description
Information about the study in Spanish
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Effectiveness of Magnetic Therapy on Pain Intensity
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