Clinical trial NCT02497066: Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain Symptoms
Official title: Randomized, Controlled, Double-blind, Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: topical
compound
pain
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2015-07-14
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numerical Pain Rating Scale (NPRS) 0-10
timeFrame: 1 month
Secondary outcomes:
measure: Change in Health Status via Rand Corporation SF-36
timeFrame: 1 month
measure: 5-point Likert Satisfaction Scale (1-5)
timeFrame: 1 month
measure: Composite outcome determined by combining the subjects average change in pain score measured by the Numerical Pain Rating Scale and their score on the 5-point Likert Satisfaction Scale.
timeFrame: 1 month
measure: Numerical Pain Rating Scale (NPRS) 0-10
timeFrame: 3 months
measure: Change in Health Status via Rand Corporation SF-36
timeFrame: 3 Months
measure: 5-point Likert Satisfaction Scale (1-5)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: WRNMMC
name: Robert E Brutcher, PharmD,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brutcher RE, Kurihara C, Bicket MC, Moussavian-Yousefi P, Reece DE, Solomon LM, Griffith SR, Jamison DE, Cohen SP. Compounded Topical Pain Creams to Treat Localized Chronic Pain: A Randomized Controlled Trial. Ann Intern Med. 2019 Mar 5;170(5):309-318. doi: 10.7326/M18-2736. Epub 2019 Feb 5.