CompletedPhase 3Other

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

Sponsored by Walter Reed National Military Medical Center

NCT ID
NCT02497066
Target Enrollment
399 participants
Start Date
2015-08-05
Est. Completion
2018-02-28

About This Study

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.

Conditions Studied

Pain

Interventions

  • Neuropathic pain cream
  • Nociceptive pain cream
  • Mixed pain cream

Eligibility

Age:18 Years - 90 Years
Healthy Volunteers:No
View full 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.

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source