Clinical trial NCT05054023: Topical Piroxicam vs Soulagel in the Treatment of Acute Extremity Pain After Emergency Department Discharge
Official title: Randomized Clinical Trial of Topical Piroxicam Versus a New Herbal Medicine Based Gel in the Treatment of Acute Extremity Pain After Emergency Department Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Pain
Keywords: soft tissues
trauma
topical
NSAID
herbal analgesics
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 1525
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients who presented to the ED with acute non-penetrating minor soft tissues musculoskeletal limb trauma occurring within 24 hours before presentation, and who required a prescription for home use analgesic treatment upon discharge for pain-on-movement (POM) with intensity \>50 on a visual numeric scale (VNS) on a standard 11 point (0-10).
* Pain was considered traumatic if it is reported as appearing immediately after the trauma and no anterior pain was described in the same limb.

Exclusion Criteria:

* Pregnancy/Breastfeeding
* Skin lesions (excessive dryness or redness of the skin, atopic dermatitis, and eczema) in the painful region
* Presence of wound, joint dislocation, or more than one injury
* Presence of a fracture
* Severe trauma (ISS \> 16)
* Hospitalization or surgery, daily use of NSAIDs or other analgesia within 2 weeks
* Previous treatment with analgesia for the same injury
* History of previous adverse reaction or known allergy or hypersensitivity
* Physical, visual, or cognitive impairment (inability to use the VNS pain score)
* Refusal to consent or to communicate

Primary outcomes:
measure: Treatment success resolution of pain with decrease of VAS more than 50% comparing to initial value at 30 minutes following analgesia administration
timeFrame: at seven days post ED discharge
measure: Occurence of severe adverse events
timeFrame: at seven days post ED discharge
Secondary outcomes:
measure: Pain resolution time
timeFrame: at seven days post ED discharge
measure: The need for rescue analgesia and
timeFrame: at seven days post ED discharge
measure: Patient Satisfaction
timeFrame: at seven days post ED discharge
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Nouira Samir
state: Emergency Department Monastir, Tunisia 5000
Study officials:
affiliation: University of Monastir
name: Semir Nouira, Professor
role: PRINCIPAL_INVESTIGATOR
References: