Neuract® cream versus placebo in the relief of neuropathic lower back pain
| ISRCTN | ISRCTN38072382 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38072382 |
| Secondary identifying numbers | 32440 |
- Submission date
- 30/05/2010
- Registration date
- 14/07/2010
- Last edited
- 19/07/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Li Li
Scientific
Scientific
Li Li, Ph.D.
Department of Kinesiology
Louisiana State University
112 Long Field House
Baton Rouge
70803
United States of America
| lli3@lsu.edu |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details provided to request a patient information sheet |
| 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 |
| Study objectives | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 14/06/2010 |
| Date of final enrolment | 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
70803
United States of America
Sponsor information
Origin Biomed, Inc (Canada)
Industry
Industry
5126 Duke Street
Suite 300
Halifax
B3J 1N7
Canada
| mclellan@originbiomed.com | |
"ROR" |
https://ror.org/008mcnd42 |
Funders
Funder type
Industry
Origin Biomed, Inc, (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
