Neuract® cream versus placebo in the relief of neuropathic lower back pain

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

Dr Li Li
Scientific

Li Li, Ph.D.
Department of Kinesiology
Louisiana State University
112 Long Field House
Baton Rouge
70803
United States of America

Email	lli3@lsu.edu

Primary study design	Interventional
Study design	Double blind randomized placebo controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase II
Drug / device / biological / vaccine name(s)	Neuract® cream
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Duration of pain reduction
Completion date	31/12/2010

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Li Li, Ph.D.

Baton Rouge
70803
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes