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

NCT05054023 | Completed Phase 2 DMC

• 1 other identifier: Topic analgesics
• Study Type: interventional
• Target: 1,525
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Keywords

soft tissues; trauma; topical; NSAID; herbal analgesics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pain resolution time

  at seven days post ED discharge

• The need for rescue analgesia and

  at seven days post ED discharge

• Patient Satisfaction

  at seven days post ED discharge

Study Arms (2)

Piroxicam gel

ACTIVE COMPARATOR

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®

Soulagel®; Belpharma Tunisia

ACTIVE COMPARATOR

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®

Interventions

Soulagel® DRUG

topic gel

Soulagel®; Belpharma Tunisia

Arthrosyl® DRUG

topic gel

Also known as: piroxicam

Piroxicam gel

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Nouira Samir

Monastir, Emergency Department Monastir, Tunisia 5000, 5000, Tunisia

Location

MeSH Terms

Conditions

Acute Pain; Wounds and Injuries

Interventions

Piroxicam

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Semir Nouira, Professor

  University of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomization was performed centrally according to a computer-generated random list performed by a blinded study investigator who was not involved in any other part of the trial. All protocol treatments were administered in opaque tube with identical appearances and were numbered according to the randomization sequence by an independent nurse who was not involved in monitoring or follow-up of the subjects. the outcome assessor was also blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Monastir Emergency department

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 23, 2021
• Study Start: October 21, 2021
• Primary Completion: March 21, 2022
• Study Completion: March 21, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

TU (1)