Topical Piroxicam vs Soulagel in the Treatment of Acute Extremity Pain After Emergency Department Discharge
Condition: Acute Pain
MeSH terms: Emergencies; Acute Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Acute soft tissues injuries are a common complaint for emergency department (ED) visit. RICE
      and Topical non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used to reduce pain
      and inflammation. Herbal therapy is commonly used to treat pain but few studies assessed its
      efficacy and tolerability.
    

Detailed description: 
      Materials and methods :

      Study design It is a randomized, prospective, double blind, controlled, multicentric trial.

      Study setting and selection of participants :

      The trial is conducted in three community teaching hospitals :

        -  Emergency department, fattouma bourgiba university hospital, monastir, tunisia.

        -  Emergency department, sahloul university hospital, sousse, tunisia.

        -  Emergency department, farhat hached university hospital, sousse, tunisia.

      The study includes patients aged 18 to 60 years who presented to the ED with acute
      soft-tissues limb trauma pain occurring within 24 hours before presentation, with a visual
      numeric scale (VNS) of 5 or more on a standard 11 point (0-10) and who required a
      prescription for home use analgesic treatment upon discharge. An informed consent is
      necessary. Pain was considered traumatic if it is reported as appearing immediately after the
      trauma.

      Protocol :

      After medical evaluation, every patient who meet the inclusion criteria, will receive
      randomly either Piroxicam gel or Soulagel tubes as detailed above according to the
      predetermined randomization.

      None of the treating physician or nurses are aware about the medication received.

      Adhesive and/or immobilizing casts, bandages, splints, and treatment by rest, ice,
      compression, or elevation were prohibited after randomization.

      Patients could not take additional medications such as oral NSAIDs, opioids, muscle
      relaxants, or supplemental topical therapies.

      Patients were phonelly contacted in order to ensure treatment adherence and evaluate VAS once
      a day until the end of the treatment. After the end of the treatment, patients' satisfaction
      with the treatment was noted and quoted as "not satisfied", "satisfied", and "very
      satisfied".

      Need for rescue analgesic treatment was noted as well as the dose and duration. All patients
      were encouraged to report all adverse events during the treatment period. S

      All data recorded on data collection sheets, including sex, demographics, medical history,
      and vital signs, were entered into SPSS (version 20.0 ; IBM corps) by the research manager.

      Patients's informed consent is obtained. The ethic commitee of our institution approved the
      study.
    

Intervention name(s): Soulagel®; Arthrosyl®
Intervention type(s): Drug; Drug
Intervention description(s): topic gel; topic gel
Other intervention name(s): piroxicam
Intervention MeSH terms: Piroxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The Soulagel was supplied in 50 ml tubes that contained rosemary essential oil (Romarinus offienalus), mint essential oil, clove essential oil (Eugenda caryophyllus), harpgophytum natural extract (Harpagophytum procumbens), meadowsweet natural extract (Filipendula ulmaria), aqua, methyl salicylate, menthol, camphre, carbomer, triethanolamine, polysorbate-20, sodium polyacrylate, trideceth-6, methylchloroisothiazolinone, methylisothiazolinone , magnesim Chloride and magnesium nitrater (Soulagel®; Belpharma Tunisia). Piroxicam gel was supplied in 50g tubes that contained 0.5% piroxicam.
Study treatments were applied on the injured site3 times per day for 7 days. The gel must be gently rubbed on the skin over the injured site for 2 minutes.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: soft tissues; trauma; topical; NSAID; herbal analgesics