Clinical trial NCT05647681: Analgesic Effect of a New Analgesic Based Gel(Douloff) Versus Oral Paracetamol in Acute Soft Injuries
Official title: Analgesic Effect of a New Analgesic Based Gel(Douloff) Versus Oral Paracetamol in Acute Soft Injuries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Analgesia
Keywords: analgesia,topic analgesic,herbal medicine
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 1100
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: multi-centre, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: at seven days ED discharge
Secondary outcomes:
measure: delta VNS, which is the change in VNS score from ED discharge (VNS D0) to 7 days later (VNS D7).
timeFrame: at seven days ED discharge
measure: Time to achieve pain resolution
timeFrame: at seven days ED discharge
measure: need for rescue analgesia
timeFrame: at seven days ED discharge
measure: patient satisfaction
timeFrame: at seven days ED discharge
measure: adverse events rate
timeFrame: at seven days ED discharge
Other outcomes:
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