Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104533
Status:
COMPLETED
Last Update Posted:
2008-03-20
First Post:
2005-03-01
Brief Title:
Effectiveness of Magnetic Therapy on Pain Intensity
Sponsor:
Javeriana University
Organization:
Javeriana University
Study Overview
Official Title:
Effectiveness of Magnetic Therapy on Pain Intensity
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 510 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 410 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 79 20 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
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 510 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 410 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 79 20 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1203-04-16295 | None | None | None |