Analgesic Effect of a New Analgesic Based Gel(Douloff) Versus Oral Paracetamol in Acute Soft Injuries (DOULOFF)

Herbal medicine is commonly used to treat pain, but little is known about its effectiveness and its place in the common arsenal of analgesics .The question of whether such herbal combinations could have similar efficacy to oral analgesics in the treatment of post-traumatic soft tissue pain has not yet been investigated. Thus, we conducted this multi-center randomized controlled trial to determine the efficacy and tolerability of a new topical herbal preparation (Douloff®) compared to oral paracetamol in the treatment of acute pain secondary to soft tissue injury.

Study Overview

• Status: Not yet recruiting
• Conditions: Analgesia
• Intervention / Treatment: Drug: Douloff; Drug: paracetamol

Detailed Description

Patients are eligible for enrollment if they are over 60 years of age, present to the emergency department with minor non-penetrating musculoskeletal soft tissue trauma occurring within 24 hours prior to admission to the emergency department, and require a prescription for home analgesic treatment at discharge: pain on movement (POM) with an intensity> 50 on a visual numeric scale (VNS) ranging from 0 to 10 (0 = no pain, 10 = maximum pain) Exclusion criteria are: skin lesions (dryness or excessive redness of the skin, atopic dermatitis and eczema) in the painful area, presence of a wound, joint dislocation or multiple injuries, fracture , patients with severe trauma (Injury Severity Score > 16), the need for hospitalization or surgery, daily use of NSAIDs or other analgesics in the 2 weeks before presentation, and previous treatment with analgesia for the same injury, Pregnant or lactating women , inability to use the VNS pain score, refusal to consent, or refusal to communicate Patients are ineligible if they have contraindications to any of the drugs in the protocol, including a history of previous adverse events or a known allergy or hypersensitivity.

Patients are randomly assigned (1:1) to receive Douloff or oral paracetamol.Randomization is performed centrally according to a computer-generated random list by a blinded research associate not involved in any other part of the trial. The subjects included are divided into two groups: the new gel (Douloff® group) or oral paracetamol (paracetamol group). All treatments in the protocol are numbered according to the randomization sequence by an independent research associate who is not involved in the monitoring or follow-up of the subjects. The topical study treatment is applied to the injured site 3 times daily for 7 days. The gel should be applied gently to the skin of the injured site for 1 minute. To minimize additional sources of response variability, adhesive and/or immobilizing casts, bandages, splints, and ice application are prohibited after randomization. Patients should be instructed to prevent water or moisture from contacting the affected area after application of topical therapy. Paracetamol is administered orally (1g three times daily).

The primary endpoint is the frequency of pain resolution defined as at least a 50% reduction in pain level (VNS) at day 7 compared with the ED discharge VNS (VNS D0) during movement (DAM).

Secondary end points included delta VNS, which is the change in VNS score from ED discharge (VNS D0) to 7 days later (VNS D7). The delta VNS is calculated as [(VNS D0 - VNS D7 / VNS D0) x 100]. Time to achieve pain resolution criteria, need for rescue analgesia, patient satisfaction, and rate of adverse events are also considered secondary endpoints. Failure to apply the gel more than three times during a treatment period constituted poor adherence.

• Study Type: Interventional
• Enrollment (Anticipated): 1100
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients are eligible for enrollment if they are over 60 years of age, present to the emergency department with minor non-penetrating musculoskeletal soft tissue trauma occurring within 24 hours prior to admission to the emergency department, and require a prescription for home analgesic treatment at discharge: pain on movement (POM) with an intensity> 50 on a visual numeric scale (VNS) ranging from 0 to 10 (0 = no pain, 10 = maximum pain)

Exclusion Criteria:

• Patients were excluded from the study:

If they had skin lesions (dryness or excessive redness of the skin, atopic dermatitis and eczema) in the painful area The presence of a wound, joint dislocation or multiple injuries. The presence of a fracture Patients with severe trauma (Injury Severity Score > 16) The need for hospitalization or surgery Daily use of NSAIDs or other analgesics in the 2 weeks before presentation, and previous treatment with analgesia for the same injury Contraindications to any of the drugs in the protocol, including a history of previous adverse events or a known allergy or hypersensitivity.

Pregnant or lactating women Inability to use the VNS pain score refusal to consent or communicate

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: topic analgesic "Douloff"; Patients receive a tpic analgesic "douloff" in association with an oral treatment "placebo"	Drug: Douloff; topic gel
Active Comparator: oral paracetamol; Patients receive oral paracetamol in association with a topic placebo	Drug: paracetamol; tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the frequency of pain resolution defined as at least a 50% reduction in pain level (VNS) at Day 7 compared with the ED discharge VNS (VNS Day 0) during movement (DAM)	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 ED discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
delta VNS, which is the change in VNS score from ED discharge (VNS D0) to 7 days later (VNS D7).	The delta VNS is calculated as [(VNS D0 - VNS D7 / VNS D0) x 100]	at seven days ED discharge
Time to achieve pain resolution	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 ED discharge
need for rescue analgesia	need for rescue analgesia	at seven days ED discharge
patient satisfaction	Satisfaction of patients evaluated with the likert score at the ED discharge.	at seven days ED discharge
adverse events rate	occurence of adverse events	at seven days ED discharge

Collaborators and Investigators

• Sponsor: University of Monastir

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: December 3, 2022
• First Submitted That Met QC Criteria: December 3, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 13, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: analgesia,topic analgesic,herbal medicine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: Urgence Monastir

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No