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

NCT ID: NCT05054023

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1525 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-21
• Study Completion Date: 2022-03-21

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.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Arthrosyl®

Intervention Type: DRUG

topic gel

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.

Group Type: ACTIVE_COMPARATOR

Soulagel®

Intervention Type: DRUG

topic gel

Interventions

Soulagel®

topic gel

Intervention Type: DRUG

Arthrosyl®

topic gel

Intervention Type: DRUG

Other Intervention Names

piroxicam

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

Monastir Emergency department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Semir Nouira, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Monastir

Locations

Nouira Samir

Monastir, Emergency Department Monastir, Tunisia 5000, Tunisia

Countries

Tunisia

Other Identifiers

Topic analgesics

Identifier Type: -

Identifier Source: org_study_id