Counterpain PXM Versus Diclofenac Versus Piroxicam
Summary
The goal of this clinical trial is to learn if a gel containing Piroxicam plus Counterirritant (warming/cooling ingredients) is as effective and safe as two other common anti-inflammatory gels for treating acute muscle, bone, and joint pain in adults aged 18-60. The main questions it aims to answer are: Does the Piroxicam plus Counterirritant gel provide a similar level of pain relief as the standard Piroxicam-only gel and the Diclofenac gel? Is the Piroxicam plus Counterirritant gel as safe to use as the other two gels? Researchers will compare three groups of participants, each using one of the gels (Piroxicam plus Counterirritant, Piroxicam-only, or Diclofenac) to see if the combination gel works equally well. Participants will: * Be randomly assigned to use one of the three gels for approximately 6 days. * Visit the clinic three times (at the start, midpoint, and end) for pain assessments, physical exams (checking movement and muscle strength), and physiotherapy sessions. * Apply their assigned gel at home three times daily (morning, afternoon, evening) and record their gel use and pain levels in a provided diary. * Receive a rescue medication (paracetamol) to use only if their pain becomes unbearable and record when they take it.
Timeline
- Start
- 2025-11-04
- Primary completion
- 2026-02-12
- Completion
- 2026-02-12
Publications
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- Background Cleland JA, Mintken PE, McDevitt A, Bieniek ML, Carpenter KJ, Kulp K, Whitman JM. Manual physical therapy and exercise versus supervised home exercise in the management of patients with inversion ankle sprain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2013;43(7):443-55. doi: 10.2519/jospt.2013.4792. Epub 2013 Apr 29.
- Background Mizner RL, Petterson SC, Snyder-Mackler L. Quadriceps strength and the time course of functional recovery after total knee arthroplasty. J Orthop Sports Phys Ther. 2005 Jul;35(7):424-36. doi: 10.2519/jospt.2005.35.7.424.
- Background McMahon SB, Dargan P, Lanas A, Wiffen P. The burden of musculoskeletal pain and the role of topical non-steroidal anti-inflammatory drugs (NSAIDs) in its treatment. Ten underpinning statements from a global pain faculty. Curr Med Res Opin. 2021 Feb;37(2):287-292. doi: 10.1080/03007995.2020.1847718. Epub 2020 Nov 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Diclofenac | Other / unclassified | 10 mg | Topical |
| Subject | Menthol | Small molecule | — | Topical |
| Subject | Methyl Salicylate | Small molecule | — | Topical |
| Comparator | Piroxicam | Unknown | 0.5 % | Topical |
| Subject | eugenol | Small molecule | — | Topical |