PainPhase 3NCT02497066
Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain Symptoms
A Phase 3 study testing Neuropathic pain cream, Nociceptive pain cream and Mixed pain cream in people with Pain, run by Walter Reed National Military Medical Center.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain
- What is being tested?
- Neuropathic pain cream, Nociceptive pain cream and Mixed pain cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 399 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2015to 28 Feb 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18;-90
- A localized pain complaint to include: the back, neck, face, groin, buttocks, abdomen, chest, or up to two extremities
- Average pain score ≥ 4/10 over the past week;
- Pain duration > 6 weeks
- DEERS eligibility.
Who cannot join
- Previous prescription for a compounded pain cream.
- Cannot read or understand English.
- Allergic reaction to Ketamine, Gabapentin, Diclofenac, Baclofen, Cyclobenzaprine, Ketoprofen, Clonidine or lidocaine.
- 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.
About this study
Official title: Randomized, Controlled, Double-blind, 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
- 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.
- 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.
Read the 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.
- Conditions
- Pain
- Being tested
- Neuropathic pain cream, Nociceptive pain cream, Mixed pain cream
- Keywords
- topical, compound, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropathic pain creamOther
Subjects will apply the cream to the painful area.
Nociceptive pain creamOther
Subjects will apply the cream to the painful area.
Mixed pain creamOther
Subjects will apply the cream to the painful area.
| Study group | Role | What they receive |
|---|---|---|
| Neuropathic Pain | Placebo comparator | Subjects with neuropathic pain will receive a neuropathic pain cream combined of Ketamine 10%/Gabapentin 6%/Clonidine 0.2% and Lidocaine 2% or placebo. They will be told to use the pain cream 3 times per day. Each will receive cream in identical dispensers. Cream is dispensed by rotating the base of the device and each rotation also produces a clicking sound. The number of clicks will be standardized so that all doctors utilize the same prescription depending on the size of the patient's pain location. Receives: Other: Neuropathic pain cream |
| Nociceptive pain | Placebo comparator | Subjects with nociceptive pain will receive a nociceptive pain cream combined of Ketoprofen 10%/Baclofen 2%/Cyclobenzaprine 2% and Lidocaine 2% or placebo. They will be told to use the pain cream 3 times per day. Each will receive cream in identical dispensers. Cream is dispensed by rotating the base of the device and each rotation also produces a clicking sound. The number of clicks will be standardized so that all doctors utilize the same prescription depending on the size of the patient's pain location. Receives: Other: Nociceptive pain cream |
| Mixed pain | Placebo comparator | Subjects who have a mixed (nociceptive and neuropathic) pain conditions will receive a mixed pain cream combined of Ketamine 10%/Gabapentin 6%/Diclofenac 3%/baclofen 2%/Cyclobenzaprine 2% and Lidocaine 2% or placebo. They will be told to use the pain cream 3 times per day. Each will receive cream in identical dispensers. Cream is dispensed by rotating the base of the device and each rotation also produces a clicking sound. The number of clicks will be standardized so that all doctors utilize the same prescription depending on the size of the patient's pain location. Receives: Other: Mixed pain cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (6)
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.
Measured: 1 month
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."
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 3 months
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.
Measured: 3 Months
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."
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study start5 Aug 2015
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Robert E Brutcher, PharmD,Ph.D., Principal investigator, WRNMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497066
- Sponsor's protocol ID
- #412770-2
- Status last verified
- Oct 2018
- First submitted
- 30 Jun 2015
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30716769
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Double-blind, Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain Symptoms
- ClinicalTrials.gov ID
- NCT02497066
- Acronym / sponsor ID
- #412770-2
- Conditions
- Pain
- Keywords
- topical, compound, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- 5 Aug 2015 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neuropathic Pain | Placebo comparator | Other: Neuropathic pain creamSubjects with neuropathic pain will receive a neuropathic pain cream combined of Ketamine 10%/Gabapentin 6%/Clonidine 0.2% and Lidocaine 2% or placebo. They will be told to use the pain cream 3 times per day. Each will receive cream in identical dispensers. Cream is dispensed by rotating the base of the device and each rotation also produces a clicking sound. The number of clicks will be standardized so that all doctors utilize the same prescription depending on the size of the patient's pain location. |
| Nociceptive pain | Placebo comparator | Other: Nociceptive pain creamSubjects with nociceptive pain will receive a nociceptive pain cream combined of Ketoprofen 10%/Baclofen 2%/Cyclobenzaprine 2% and Lidocaine 2% or placebo. They will be told to use the pain cream 3 times per day. Each will receive cream in identical dispensers. Cream is dispensed by rotating the base of the device and each rotation also produces a clicking sound. The number of clicks will be standardized so that all doctors utilize the same prescription depending on the size of the patient's pain location. |
| Mixed pain | Placebo comparator | Other: Mixed pain creamSubjects who have a mixed (nociceptive and neuropathic) pain conditions will receive a mixed pain cream combined of Ketamine 10%/Gabapentin 6%/Diclofenac 3%/baclofen 2%/Cyclobenzaprine 2% and Lidocaine 2% or placebo. They will be told to use the pain cream 3 times per day. Each will receive cream in identical dispensers. Cream is dispensed by rotating the base of the device and each rotation also produces a clicking sound. The number of clicks will be standardized so that all doctors utilize the same prescription depending on the size of the patient's pain location. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18;-90
- A localized pain complaint to include: the back, neck, face, groin, buttocks, abdomen, chest, or up to two extremities
- Average pain score ≥ 4/10 over the past week;
- Pain duration > 6 weeks
- DEERS eligibility.
Key exclusion criteria (4 listed)
- Previous prescription for a compounded pain cream.
- Cannot read or understand English.
- Allergic reaction to Ketamine, Gabapentin, Diclofenac, Baclofen, Cyclobenzaprine, Ketoprofen, Clonidine or lidocaine.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropathic pain creamSubjects will apply the cream to the painful area. | Other | Neuropathic Pain |
| Nociceptive pain creamSubjects will apply the cream to the painful area. | Other | Nociceptive pain |
| Mixed pain creamSubjects will apply the cream to the painful area. | Other | Mixed pain |
Primary outcome
Numerical Pain Rating Scale (NPRS) 0-10
Time frame: 1 month
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.
6 secondary outcomes
Change in Health Status via Rand Corporation SF-36
Time frame: 1 month
5-point Likert Satisfaction Scale (1-5)
Time frame: 1 month
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.
Time frame: 1 month
Numerical Pain Rating Scale (NPRS) 0-10
Time frame: 3 months
Change in Health Status via Rand Corporation SF-36
Time frame: 3 Months
5-point Likert Satisfaction Scale (1-5)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Derived from this study: PubMed 30716769Brutcher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert E Brutcher, PharmD,Ph.D. principal investigator
WRNMMC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neuropathic pain cream, Nociceptive pain cream and Mixed pain cream in people with Pain, run by Walter Reed National Military Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (NPRS) 0-10 (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02497066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.