Spinal Magnetic Stimulation in Neuropathic Pain

This study has been completed.

Sponsor:

Information provided by:

Singapore General Hospital

ClinicalTrials.gov Identifier:

NCT00443469

First received: March 4, 2007

Last updated: March 30, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

March 4, 2007

Last Updated Date

March 30, 2010

Start Date ^ICMJE

August 2006

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Subjective pain score measurements [ Time Frame: 4 days ] [ Designated as safety issue: No ]

NAS score

Original Primary Outcome Measures ^ICMJE

Subjective pain score measurements after SMS

Change History

Complete list of historical versions of study NCT00443469 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Spinal Magnetic Stimulation in Neuropathic Pain

Official Title ^ICMJE

A Randomized Placebo-controlled Trial on the Use of Repetitive Spinal Magnetic Stimulation as a Therapeutic Option in Patients With Intractable Neuropathic Pain of the Lower Limbs

Brief Summary

It involves delivering a train of magnetic pulses, 5 at each time, to the brain. In the present study, we are using the same method to treat severe pain due to nerve conditions. You will be given up to 1000 pulses in total over the spine in the lower back (Spinal Magnetic Stimulation or SMS). Each train will be given in 10-second intervals. You will have SMS on a single day. You will be given SMS pulses at 1 or 10 per second. No stimulation will be given over the head.

You will be assessed before and after the study for up to 1 week. Your usual medical treatment will be continued

Detailed Description

You must be aware of that this is a placebo-controlled trial. This means that you may either receive real SMS or sham SMS. The latter involves a harmless process of ineffective stimulation, designed for comparison with real SMS. Whether you receive either form of treatment will be assigned randomly, and there will be a 50% chance of being assigned to either.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Neuropathic Pain

Intervention ^ICMJE

Device: magnetic stimulation
SMS was delivered with a repetitive magnetic stimulator connected to a figure of eight coil capable of delivering a maximum output of 2 Tesla per pulse. The coil measured 90 mm in each wing and was centered over the surface landmark corresponding to the cauda equina region. SMS was performed with the patient lying comfortably in the prone position and a soft pillow supported the lower abdomen. The coil was placed flat over the back with the handle pointing cranially. Each patient on active treatment received 200 trains of 5 pulses delivered at 10 Hz, at an interval of 5 s between each train. As this was a pilot study, each only received 1000 pulses in a single session.
Device: Magnetic Stimulation with tilted coil
The placebo arm consisted of 'sham' SMS delivered with the coil angled vertically and one of the wing edges in contact with the stimulation point. As this coil type allows maximum magnetic flux at the center of the intersection, we believe minimum or no stimulation was effected at the edge of the coil in contact with the patient. Stimulation parameters and duration were unchanged in this arm.

Study Arm (s)

Experimental: Magnetic Stimulation
Intervention: Device: magnetic stimulation
Placebo Comparator: Magnetic Stimulation with tilted coil
Magnetic Stimulation with tilted coil

Intervention: Device: Magnetic Stimulation with tilted coil

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2010

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

All with neuropathic lower limb pain

Exclusion Criteria:

Contraindications to magnetic stimulation

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Singapore

Administrative Information

NCT Number ^ICMJE

NCT00443469

Other Study ID Numbers ^ICMJE

#64/2006

Has Data Monitoring Committee

Yes

Responsible Party

A/Prof Lo YL, Singapore General Hospital, NNI

Study Sponsor ^ICMJE

Singapore General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

YL Lo, MD

National Neuroscience Institute, Singapore General Hospital

Information Provided By

Singapore General Hospital

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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