Effectiveness of Magnetic Therapy on Pain Intensity
Tracking Information | |||||
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First Received Date ICMJE | March 1, 2005 | ||||
Last Updated Date | March 19, 2008 | ||||
Start Date ICMJE | September 2004 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Pain intensity at rest | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00104533 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Effectiveness of Magnetic Therapy on Pain Intensity | ||||
Official Title ICMJE | Effectiveness of Magnetic Therapy on Pain Intensity | ||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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Condition ICMJE | Postoperative Pain | ||||
Intervention ICMJE | Device: Magnets | ||||
Study Arm (s) | |||||
Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 164 | ||||
Completion Date | September 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 8 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Colombia | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00104533 | ||||
Other Study ID Numbers ICMJE | 1753, 1203-04-16295 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Javeriana University | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Javeriana University | ||||
Verification Date | March 2005 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |