Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain Symptoms

Pain Clinical Trial

Official title:

Randomized, Controlled, Double-blind, Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497066
• Other study ID #: #412770-2
• Status: Completed
• Phase: Phase 3
• Start date: August 5, 2015
• Est. completion date: February 28, 2018

Study information

• Verified date: October 2018
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Neuropathic pain cream
Subjects will apply the cream to the painful area.
• Nociceptive pain cream
Subjects will apply the cream to the painful area.
• Mixed pain cream
Subjects will apply the cream to the painful area.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Pain Rating Scale (NPRS) 0-10	The Numerical Pain Rating Scale is a unidimensional measure of pain intensity. It is an 11 point numerical scale (with 0 meaning no pain; and 10 meaning the worst possible pain imaginable) used to assess pain intensity for persons able to self-report.	1 month
Secondary	Change in Health Status via Rand Corporation SF-36	The SF-36 is a 36 item Short Form Health Survey that is used to measure changes in health status. It is a set of generic, coherent, and easily administered quality-of-life measures. It is a validated measure of 8 domains including emotional health and physical function, with lower scores translating to greater disability.	1 month
Secondary	5-point Likert Satisfaction Scale (1-5)	The 5-point Likert Satisfaction Scale is a 5 point scale that is used to measure the subjects opinion/perception of their satisfaction with the compounded product. The scale ranges from 1-5; with 1 denoting "very unsatisfied" and 5 signifying "very satisfied."	1 month
Secondary	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.	A positive composite outcome was defined as a decrease in average pain of 2 points or greater and a satisfaction score greater than 3.	1 month
Secondary	Numerical Pain Rating Scale (NPRS) 0-10	The Numerical Pain Rating Scale is a unidimensional measure of pain intensity. It is an 11 point numerical scale (with 0 meaning no pain; and 10 meaning the worst possible pain imaginable) used to assess pain intensity for persons able to self-report.	3 months
Secondary	Change in Health Status via Rand Corporation SF-36	The SF-36 is a 36 item Short Form Health Survey that is used to measure changes in health status. It is a set of generic, coherent, and easily administered quality-of-life measures. It is a validated measure of 8 domains including emotional health and physical function, with lower scores translating to greater disability.	3 Months
Secondary	5-point Likert Satisfaction Scale (1-5)	The 5-point Likert Satisfaction Scale is a 5 point scale that is used to measure the subjects opinion/perception of their satisfaction with the compounded product. The scale ranges from 1-5; with 1 denoting "very unsatisfied" and 5 signifying "very satisfied."	3 months