Contact information
Type
Scientific
Contact name
Dr Li Li
ORCID ID
Contact details
Li Li
Ph.D.
Department of Kinesiology
Louisiana State University
112 Long Field House
Baton Rouge
70803
United States of America
lli3@lsu.edu
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
32440
Study information
Scientific title
The effectiveness of Neuract® cream versus placebo in the relief of neuropathic lower back pain: a double-blind randomised placebo-controlled clinical trial
Acronym
Study hypothesis
Neuract® is more effective in relieving neuropathic lower back pain than placebo.
Ethics approval(s)
Institutional Review Board (IRB), Louisiana State University approved on the 22nd of March 2010 (ref: 2760)
Study design
Double blind randomized placebo controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details provided to request a patient information sheet
Condition
Neuropathic lower back pain
Intervention
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.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase II
Drug/device/biological/vaccine name(s)
Neuract® cream
Primary outcome measure
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.
Secondary outcome measures
Duration of pain reduction
Overall study start date
14/06/2010
Overall study end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
60
Participant exclusion criteria
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
Recruitment start date
14/06/2010
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United States of America
Study participating centre
Li Li, Ph.D.
Baton Rouge
70803
United States of America
Sponsor information
Organisation
Origin Biomed, Inc (Canada)
Sponsor details
5126 Duke Street
Suite 300
Halifax
B3J 1N7
Canada
mclellan@originbiomed.com
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Origin Biomed, Inc, (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|