Condition category
Musculoskeletal Diseases
Date applied
30/05/2010
Date assigned
14/07/2010
Last edited
19/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Other

Trial 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

Phase

Phase II

Drug names

Neuract® cream

Primary outcome measures

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 trial start date

14/06/2010

Overall trial end date

31/12/2010

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes