Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain Symptoms
Condition: Pain
MeSH terms: Pain
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Neuropathic pain cream; Nociceptive pain cream; Mixed pain cream
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects will apply the cream to the painful area.; Subjects will apply the cream to the painful area.; Subjects will apply the cream to the painful area.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: topical; compound; pain