Postoperative PainPhase 3NCT00104533
Effectiveness of Magnetic Therapy on Pain Intensity
A Phase 3 study testing Magnets in people with Postoperative Pain, run by Javeriana University at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Magnets
- Type of treatment
- Medical device
- How many people
- 164 participants
- Where
- 1 siteColombia
- Study dates
- Sep 2004to Sep 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospitalized or ambulatory patients 8 years old or older subjected to surgical procedures under general anesthesia, who reported at least moderate pain.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Magnets
- Keywords
- Static magnetic therapy, Pain, Analgesia, Opioids
- Medical subject headings
- Pain, Postoperative, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity at rest
Secondary outcomes (2)
Opioid requirements
Opioid side effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2005 (estimated)
- Study startSep 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 164 participants
Sponsor and investigators
- Lead sponsor
- Javeriana University
- Sponsor type
- University, hospital or other
- Investigators
- M. Soledad Cepeda, MD, PhD, Principal investigator, Javeriana University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104533
- Sponsor's protocol ID
- 1753
- Other IDs
- 1203-04-16295
- Status last verified
- Mar 2005
- First submitted
- 1 Mar 2005
- Last updated
- 20 Mar 2008
- Results posted
- No
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. doi: 10.1213/01.ane.0000230613.25754.08.
PubMed 17242082
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Magnetic Therapy on Pain Intensity
- ClinicalTrials.gov ID
- NCT00104533
- Acronym / sponsor ID
- 1753
- Conditions
- Postoperative Pain
- Keywords
- Static magnetic therapy, Pain, Analgesia, Opioids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants
- Lead sponsor
- Javeriana UniversityUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Sep 2005 (actual)
- First posted
- 2 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized or ambulatory patients 8 years old or older subjected to surgical procedures under general anesthesia, who reported at least moderate pain.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnets | Device | – |
Primary outcome
Pain intensity at rest
2 secondary outcomes
Opioid requirements
Opioid side effects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2008.
- Results publication: PubMed 17242082Cepeda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Soledad Cepeda, MD, PhD principal investigator
Javeriana University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnets in people with Postoperative Pain, run by Javeriana University at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity at rest. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00104533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2008.