Topical Piroxicam vs Soulagel in the Treatment of Acute Extremity Pain After Emergency Department Discharge (TPS)

Randomized Clinical Trial of Topical Piroxicam Versus a New Herbal Medicine Based Gel in the Treatment of Acute Extremity Pain After Emergency Department Discharge

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Arthrosyl®; Drug: Soulagel®

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.

• Study Type: Interventional
• Enrollment (Actual): 1525
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Tunisia
  • Emergency Department Monastir, Tunisia 5000
    • Monastir, Emergency Department Monastir, Tunisia 5000, Tunisia, 5000
      • Nouira Samir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Piroxicam gel; 50g tubes that contained 0.5% piroxicam. the gel was gently massaged in the injured site for 1 minute, 3 times a day for 7 days.	Drug: Arthrosyl®; topic gel; Other Names: piroxicam
Active Comparator: Soulagel®; Belpharma Tunisia; 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 nitrate. the gel was gently massaged in the injured site for 1 minute, 3 times a day for 7 days.	Drug: Soulagel®; topic gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success resolution of pain with decrease of VAS more than 50% comparing to initial value at 30 minutes following analgesia administration	resolution of pain with decrease of visual numeric scale (that range from 0: no pain to 10 :severe pain) more than 50% comparing to initial value	at seven days post ED discharge
Occurence of severe adverse events	occurence of severe adverse events	at seven days post ED discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain resolution time	time between the start of the analgesic treatment and the one when VNS (that range from 0: no pain to 10 :severe pain) decreased to less than 3.	at seven days post ED discharge
The need for rescue analgesia and	doses of morphine required to reach efficient analgesia	at seven days post ED discharge
Patient Satisfaction	Satisfaction of patients evaluated with the likert score at the ED discharge. (at 120 minutes patients were asked to rate the severity of nasal irritation on a 1 to 10 ordinal scale anchored.	at seven days post ED discharge

Collaborators and Investigators

• Sponsor: University of Monastir

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): March 21, 2022
• Study Completion (Actual): March 21, 2022

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: trauma; NSAID; topical; soft tissues; herbal analgesics
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Piroxicam
• Other Study ID Numbers: Topic analgesics

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No