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ISRCTN
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ISRCTN38072382
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ClinicalTrials.gov identifier
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Public title
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Neuract® cream versus placebo in the relief of neuropathic lower back pain
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Scientific title
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The effectiveness of Neuract® cream versus placebo in the relief of neuropathic lower back pain: a double-blind randomised placebo-controlled clinical trial
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Acronym
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N/A
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Serial number at source
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32440
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Study hypothesis
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Neuract® is more effective in relieving neuropathic lower back pain than placebo.
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Lay summary
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Ethics approval
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Institutional Review Board (IRB), Louisiana State University approved on the 22nd of March 2010 (ref: 2760)
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Study design
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Double blind randomized placebo controlled clinical trial
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Neuropathic lower back pain
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Participants - inclusion criteria
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1. At least 21 years old
2. Diagnosed with neuropathic lower back pain for at least 3 months
3. Pain at or more than level 5 but no more than 9 on a 0-10 scale
4. Score at least 6 of 10 on the modified DN4 questionnaire
5. Normal cognitive and communication skills
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Participants - exclusion criteria
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1. Pregnant, breastfeeding or planning on becoming pregnant in the next 3 months
2. Previous adverse reaction to use of topical analgesic
3. Current use of topical analgesic on lower back area
4. Evidence of other types of pain as, or more severe, than the pain under study
5. Diagnosis of psychological disorder requiring treatment
6. History of eczema/atopy/anaphylaxis or unusual skin reactions
7. Self reported sensitivity to perfumes, essential oils, odors
8. Changes to current pain management regime within the previous 30 days prior to start of study
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Anticipated start date
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14/06/2010
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Anticipated end date
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31/12/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details provided to request a patient information sheet
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Target number of participants
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60
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Interventions
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Patients will be randomised to receive a topical dose of Neuract® or placebo.
For each treatment arm, a pre-packaged single dose, approximately 1ml, will be applied. The pain reduction effects will be monitored starting 30 minutes after the application, up to 8 hours. Both the actual treatment and the placebo will be used only once and pain reduction effects compared to baseline pain measured 30 minutes before the treatment application.
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Primary outcome measure(s)
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Level of pain on a 0-10 visual scale, measured 30 minutes before and after the application of of the treatment, and every hour thereafter for 8 hours.
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Secondary outcome measure(s)
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Duration of pain reduction
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Sources of funding
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Origin Biomed, Inc, (Canada)
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Trial website
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Publications
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Contact name
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Dr
Li
Li
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Address
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Li Li, Ph.D.
Department of Kinesiology
Louisiana State University
112 Long Field House
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City/town
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Baton Rouge
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Zip/Postcode
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70803
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Country
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United States of America
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Email
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lli3@lsu.edu
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Sponsor
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Origin Biomed, Inc (Canada)
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Address
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5126 Duke Street
Suite 300
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City/town
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Halifax
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Zip/Postcode
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B3J 1N7
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Country
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Canada
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Email
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mclellan@originbiomed.com
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Date applied
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30/05/2010
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Last edited
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19/07/2010
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Date ISRCTN assigned
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14/07/2010
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