NCT00104533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for phase_3 postoperative-pain

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

March 20, 2008

Status Verified

March 1, 2005

First QC Date

March 1, 2005

Last Update Submit

March 19, 2008

Conditions

Postoperative Pain

Keywords

Static magnetic therapyPainAnalgesiaOpioids

Outcome Measures

Primary Outcomes (1)

  • Pain intensity at rest

Secondary Outcomes (2)

  • Opioid requirements

  • Opioid side effects

Interventions

MagnetsDEVICE

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Ignacio Hospital

Bogotá, DC, Colombia

Location

Related Publications (1)

  • 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.

    PMID: 17242082RESULT

MeSH Terms

Conditions

Pain, PostoperativePainAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • M. Soledad Cepeda, MD, PhD

    Javeriana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2005

First Posted

March 2, 2005

Study Start

September 1, 2004

Study Completion

September 1, 2005

Last Updated

March 20, 2008

Record last verified: 2005-03

Locations

CO(1)