Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain Symptoms
Information source: Walter Reed National Military Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Neuropathic pain cream (Other); Nociceptive pain cream (Other); Mixed pain cream (Other)
Phase: Phase 3
Status: Enrolling by invitation
Sponsored by: Walter Reed National Military Medical Center Official(s) and/or principal investigator(s): Robert E Brutcher, PharmD,Ph.D., Principal Investigator, Affiliation: WRNMMC
Summary
The main objective of this protocol is to determine the effectiveness of using compounded
topical pain creams for treating neuropathic, nociceptive, or mixed-pain syndromes. Since
these compounded pain creams may be associated with burning or irritation at the application
site, and possible systemic effects may present, the secondary objective is to determine the
relative satisfaction with the creams. The investigators hypothesis is that the active pain
creams may provide significant benefit compared to placebo cream.
3. 1 Specific Aims
1. Specific Aim 1 will determine pain relief following treatment with the appropriate
(based on specified pain) compounded topical pain cream or a placebo cream. The
investigators hypothesis is that the compounded topical pain creams will provide
greater pain relief than placebo creams.
2. Specific Aim 2 will measure the patient satisfaction with the cream (compound or
placebo). The investigators hypothesis is that the compounded topical pain creams will
improve patient satisfaction, while the placebo cream will not result in a change in
patient satisfaction with their pain treatment.
Clinical Details
Official title: Randomized, Controlled, Double-blind, Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain Symptoms
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Numerical Rating Pain Score (NRS) 0-10Numerical Rating Pain Score (NRS) 0-10
Secondary outcome: Change in Health Status via Rand Corporation SF-36Change in Health Status via Rand Corporation SF-36 Likert Satisfaction Scale (1-5) Likert Satisfaction Scale (1-5)
Detailed description:
In this study, the investigators are attempting to determine whether compounded topical pain
creams are more effective than placebo; as well as measuring the subjects' satisfaction with
the compounded pain creams. Three different compounded pain creams (specific to the type of
pain being treated) will be used to examine effectiveness and satisfaction in treating
neuropathic, nociceptive, or mixed pain syndromes. Up to 399 subjects will be randomized to
receive a compounded pain cream or placebo. The type of pain cream to be used will be based
on the subjects' pain diagnosis. Pain relief will be measured by a 0-10 Numeric Rating Scale
and satisfaction by a 1-5 Likert Satisfaction Scale. The outcome measures will include a
'positive outcome' defined as a two point or greater reduction in average pain (as measured
by a NRS) and a score of 4 or 5 (on a 1-5 Likert scale measuring satisfaction) at 1-month.
The investigators will use the Rand Corporation SF-36 to measure changes in health status
during enrollment. Subjects who obtain benefit at 1-month will be followed at 3-months,
while those who fail to obtain benefit (i. e., ≥ 2 point reduction in NRS with a 4 or 5
Likert satisfaction score) will exit the study to receive alternative care. Patients will be
given a pain diary so that their NRS can be calculated at follow up visits.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age > 18;-90
2. A localized pain complaint to include: the low back, neck, groin, buttocks or up to
two extremities
3. Average pain score ≥ 4/10 over the past week;
4. Pain duration > 6 weeks
5. DEERS eligibility.
Exclusion Criteria:
1. Previous prescription for a compounded pain cream.
2. Cannot read or understand English.
3. Allergic reaction to Ketamine, Gabapentin, Diclofenac, Baclofen, Cyclobenzaprine,
Ketoprofen, Clonidine or lidocaine.
4. Pregnancy. Ruling out pregnancy will be done in accordance with our standard
procedures, which is to obtain a urine HCG in any female of child-bearing age who may
be pregnant prior to starting any new medications.
Locations and Contacts
Additional Information
Starting date: June 2015
Last updated: July 10, 2015
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