Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain Symptoms
Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain Symptoms
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.
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 greater than 3 (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
 greater than 3 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.
Inclusion Criteria:

 1. Age > 18;-90

 2. A localized pain complaint to include: the back, neck, face, groin, buttocks, abdomen,
 chest, 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.