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Spinal Magnetic Stimulation in Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT00443469
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : March 31, 2010
Sponsor:
Information provided by:
Singapore General Hospital

Study Description
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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


Condition or disease Intervention/treatment Phase
Neuropathic Pain Device: magnetic stimulation Device: Magnetic Stimulation with tilted coil Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2006
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: Magnetic Stimulation 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.
Placebo Comparator: Magnetic Stimulation with tilted coil
Magnetic Stimulation with tilted coil
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Subjective pain score measurements [ Time Frame: 4 days ]
    NAS score


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All with neuropathic lower limb pain

Exclusion Criteria:

  • Contraindications to magnetic stimulation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443469


Locations
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Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Investigators
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Principal Investigator: YL Lo, MD National Neuroscience Institute, Singapore General Hospital
More Information
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Responsible Party: A/Prof Lo YL, Singapore General Hospital, NNI
ClinicalTrials.gov Identifier: NCT00443469    
Other Study ID Numbers: #64/2006
First Posted: March 6, 2007    Key Record Dates
Last Update Posted: March 31, 2010
Last Verified: March 2010
Keywords provided by Singapore General Hospital:
magnetic stimulation
neuropathic pain
spinal
lower limb
clinical trial
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Pain
Neurologic Manifestations