Acute PainPhase 2/3TPSNCT05054023
Topical Piroxicam vs Soulagel in the Treatment of Acute Extremity Pain After Emergency Department Discharge
A Phase 2/3 study testing Soulagel® and Arthrosyl® in people with Acute Pain, run by University of Monastir at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Soulagel® and Arthrosyl®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,525 participants
- Where
- 1 siteTunisia
- Study dates
- 21 Oct 2021to 21 Mar 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Nouira Samir
Monastir, Emergency Department Monastir, Tunisia 5000, 5000
About this study
Official title: 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.
Read the 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
- Being tested
- Soulagel®, Arthrosyl®
- Keywords
- soft tissues, trauma, topical, NSAID, herbal analgesics
- Medical subject headings
- Acute Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soulagel®Drug
topic gel
Arthrosyl®Drug
Also called piroxicam
topic gel
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Soulagel® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at seven days post ED discharge
Occurence of severe adverse events
occurence of severe adverse events
Measured: at seven days post ED discharge
Secondary outcomes (3)
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.
Measured: at seven days post ED discharge
The need for rescue analgesia and
doses of morphine required to reach efficient analgesia
Measured: 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.
Measured: at seven days post ED discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start21 Oct 2021
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,525 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Semir Nouira, Professor, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054023
- Sponsor's protocol ID
- Topic analgesics
- Acronym
- TPS
- Status last verified
- Jun 2022
- First submitted
- 10 Sep 2021
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Topical Piroxicam Versus a New Herbal Medicine Based Gel in the Treatment of Acute Extremity Pain After Emergency Department Discharge
- ClinicalTrials.gov ID
- NCT05054023
- Acronym / sponsor ID
- TPS / Topic analgesics
- Conditions
- Acute Pain
- Keywords
- soft tissues, trauma, topical, NSAID, herbal analgesics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,525 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Piroxicam gel | Active comparator | Drug: Arthrosyl®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. |
| Soulagel®; Belpharma Tunisia | Active comparator | Drug: Soulagel®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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soulagel®topic gel | Drug | Soulagel®; Belpharma Tunisia |
| Arthrosyl®Also: piroxicamtopic gel | Drug | Piroxicam gel |
Primary outcome
Treatment success resolution of pain with decrease of VAS more than 50% comparing to initial value at 30 minutes following analgesia administration
Time frame: at seven days post ED discharge
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
Occurence of severe adverse events
Time frame: at seven days post ED discharge
occurence of severe adverse events
3 secondary outcomes
Pain resolution time
Time frame: at seven days post ED discharge
The need for rescue analgesia and
Time frame: at seven days post ED discharge
Patient Satisfaction
Time frame: at seven days post ED discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semir Nouira, Professor principal investigator
University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Soulagel® and Arthrosyl® in people with Acute Pain, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success resolution of pain with decrease of VAS more than 50% comparing to initial value at 30 minutes following analgesia administration (time frame: at seven days post ED discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.