Neuropathic PainPhase 2/3MESO-SDRCNCT04650074
Effectiveness of Ketamine Administered by Mesotherapy in Complex Regional Pain Syndrome Type 1 (CRPS1)
A Phase 2/3 study testing LIDOCAINE 20 mg, LIDOCAINE 20 mg + KETAMINE 20 mg and LIDOCAINE 20 mg + KETAMINE 40 mg in people with Neuropathic Pain and Complex Regional Pain Syndrome Type 1, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Complex Regional Pain Syndrome type 1 (CRPS1) is a disabling pain syndrome. Its definitive treatment has not been established and the results of current treatments are often unsatisfactory. The prognosis is difficult to establish because the vast majority of CRPS regresses within a few weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Complex Regional Pain Syndrome Type 1
- What is being tested?
- LIDOCAINE 20 mg, LIDOCAINE 20 mg + KETAMINE 20 mg and LIDOCAINE 20 mg + KETAMINE 40 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2021to 12 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male / female aged ≥18 years,
- Patient suffering from Complex Regional Pain Syndrome Type 1 (CRPS1), according to the Budapest criteria, with a neuropathic component limited to the lower or upper limbs diagnosed by the Neuropathic pain DN4 Questionnaire
- Patient having undergone a three-stage dynamic bone scan less than 3 months old : vascular, tissue, bone, showing diffuse and extensive hyperfixation in the area suspected of CRPS1,
- Negative urinary pregnancy test in women of childbearing age,
- VAS (Visual Analogue Scale) > 50mm (on a scale of 0 to 100 mm) at inclusion,
- Patients affiliated to the French social security system,
- Writing informed consent obtained.
Who cannot join
- Patient with the following medical history or ongoing pathologies: epilepsy, hypertension (> 180mm / 100mm Hg), unbalanced coronary artery disease, recent myocardial infarction (MDI) (less than 12 months), porphyria, hyperthyroidism, known Behçet's disease, known blood crass disorder or PT (Prothrombin Time) <20%, known psychiatric disorders, known septic osteoarticular disease,
- Patient with HIV ((Human Immunodeficiency Viruses) infection, immunosuppression and / or immunosuppressive treatment
- Severe heart failure,
- History of severe allergy (angioedema),
- Known allergies to Cr and Zn,
- Current skin infection,
Show all 12Show fewer
- Skin lesion next to the injection area
- Phobia of injections,
- Known hypersensitivity to ketamine hydrochloride or chlorobutanol,
- Known hypersensitivity to lidocaine hydrochloride or to amide-linked local anesthetics,
- Pregnant or breastfeeding woman
- Patient under protective measure (safeguard measure, curatorship, guardianship) or deprived of liberty.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of orthopedic surgery and trauma emergencies of the lower limb, Edouard Herriot Hospital, Hospices Civils de Lyon
Lyon, 69437
About this study
Official title: Pilot Study to Evaluate the Effectiveness of a Mixture of Ketamine / Lidocaine Administered by Mesotherapy in the Management of Neuropathic Pain in Complex Regional Pain Syndrome Type 1 (CRPS1). A Monocentric Randomized and Controlled Clinical Study
Complex Regional Pain Syndrome type 1 (CRPS1) is a disabling pain syndrome. Its definitive treatment has not been established and the results of current treatments are often unsatisfactory.
The prognosis is difficult to establish because the vast majority of CRPS regresses within a few weeks. However, some forms are hyperalgesic with a major chronic painful picture, very debilitating and responding poorly to treatments with possible permanent sequelae.
Read more
The management of CRPS remains difficult and unsatisfactory and is symptomatic, multidimensional and multidisciplinary involving medical, paramedical and socio-professional workers. The priority therapeutic objectives are analgesia, maintenance or gain of joint range and maintenance or restoration of motor functions. This treatment is not the subject of a consensus and its implementation is sometimes the responsibility of specialized centers such as "pain relief" centers or even Physical Medicine and Rehabilitation (MPR) structures.
Previous studies using ketamine as a treatment for CRPS1 show encouraging results with a decrease in neuropathic pain. Ketamine is a low dose pain reliever. Ketamine has been studied as an adjuvant for the treatment of chronic pain, particularly neuropathic pain. The results suggest that ketamine decreases pain intensity and reduces opioid reliance when used as an adjunct to chronic and acute pain. Ketamine is believed to have a greater analgesic effect in patients with CRPS1 compared to other chronic pain syndromes. In these studies, ketamine was used intravenously, subcutaneously, orally, intranasally, or topically.
Mesotherapy allows microdose local treatment to be carried out limiting side effects, ensuring compliance and easy to implement. The injected solutions often contain a local anesthetic (procaine or lidocaine). It allows better local tolerance from the start of treatment. In addition, through its vasodilator effect on the microcirculation, it increases the effectiveness and tolerance of other injected products.
There are no studies using ketamine administrated by mesotherapy. Based on the scientific literature, there are good reasons to believe that this treatment could be effective on the neuropathic pain of CRPS1 and well tolerated.
- Being tested
- LIDOCAINE 20 mg, LIDOCAINE 20 mg + KETAMINE 20 mg, LIDOCAINE 20 mg + KETAMINE 40 mg
- Keywords
- Complex Regional Pain Syndrome Type 1, Mesotherapy, Lidocaïne, Ketamine, Randomized clinical trial
- Medical subject headings
- Neuralgia, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIDOCAINE 20 mgDrug
4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine (qsp 6 ml NaCl 0.9%).
Each mesotherapy session includes 2 steps performed chronologically. It will be done within 2 or 3 minutes each one:
- 1st sequence: intra-epidermal injections of 3 ml by manual technique in crossed lines with a 13 mm x 0.30 needle,
- 2nd sequence : superficial intradermal injections of 3 ml (between 1 and 2 mm) using a technique assisted by a Pistor Eliance injector at a frequency of 200 punctures per minute.
LIDOCAINE 20 mg + KETAMINE 20 mgDrug
4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine + 20 mg Ketamine (qsp 6 ml NaCl 0.9%).
Each mesotherapy session includes 2 steps performed chronologically. It will be done within 2 or 3 minutes each one:
- 1st sequence: intra-epidermal injections of 3 ml by manual technique in crossed lines with a 13 mm x 0.30 needle,
- 2nd sequence : superficial intradermal injections of 3 ml (between 1 and 2 mm) using a technique assisted by a Pistor Eliance injector at a frequency of 200 punctures per minute.
LIDOCAINE 20 mg + KETAMINE 40 mgDrug
4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine + 40 mg Ketamine (qsp 6 ml NaCl 0.9%).
Each mesotherapy session includes 2 steps performed chronologically. It will be done within 2 or 3 minutes each one:
- 1st sequence: intra-epidermal injections of 3 ml by manual technique in crossed lines with a 13 mm x 0.30 needle,
- 2nd sequence : superficial intradermal injections of 3 ml (between 1 and 2 mm) using a technique assisted by a Pistor Eliance injector at a frequency of 200 punctures per minute
| Study group | Role | What they receive |
|---|---|---|
| LIDOCAINE 20 mg | Active comparator | 4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine (qsp 6 ml NaCl 0.9%). Receives: Drug: LIDOCAINE 20 mg |
| LIDOCAINE 20 mg + KETAMINE 20 mg | Experimental | 4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine + 20 mg Ketamine (qsp 6 ml NaCl 0.9%). Receives: Drug: LIDOCAINE 20 mg + KETAMINE 20 mg |
| LIDOCAINE 20 mg + KETAMINE 40 mg | Experimental | 4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine + 40 mg Ketamine (qsp 6 ml NaCl 0.9%). Receives: Drug: LIDOCAINE 20 mg + KETAMINE 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) score
Pain measured by VAS (Visual Analogue Scale)
Measured: On day 0 (inclusion) and day 56 (end of patient follow-up)
Secondary outcomes (7)
Evolution of the Visual Analogue Scale score
The VAS (Visual Analogue Scale) score will be assessed at inclusion, before each mesotherapy session, and at the end of the patient follow-up
Measured: On day 0 (inclusion), on day 1, day 7, day 14 and day 28 (mesotherapy sessions), and on day 56 (end of patient follow-up)
Neuropathic Pain Symptom Inventory (NPSI) self-questionnaire score
The Neuropathic pain will be assessed using the NPSI (Neuropathic Pain Symptom Inventory self-questionnaire) at inclusion, before each mesotherapy session, and at the patients withdrawal.
Measured: On day 0 (inclusion), on day 1, day 7, day 14 and day 28 (mesotherapy sessions), and on day 56 (end of the patient follow-up)
Brief Pain Inventory (BPI) self-questionnaire score
The main dimensions of pain (i.e. intensity, functional disability, social and family repercussions as well as the level of psychological distress) will be assessed using the BPI (Brief Pain Inventory self-questionnaire) at inclusion and at the patients withdrawal.
Measured: On day 0 (inclusion) and on day 56 (end of patient follouw-up)
Relevant adverse events
The relevant adverse events (AEs), as well as the average of the highest grades of the relevant adverse events, will be collected during the patient follow-up, in particular after each mesotherapy session. The physician will ask the patient at each of the visits and will report any adverse event (AE). The nature and intensity of the AE will be assessed according to the Common Terminology Criteria for Adverse Events grid (CTCAE version 5.0). Relevant adverse events (AEs at least possibly related to treatment or mesotherapy) will be considered.
Measured: Until day 56 (end of patient follow-up)
Concomitant consumption of analgesics
The consumption of other analgesics concomitant with the treatment will be recorded
Measured: Until day 56 (end of patient follow-up)
EQ-5D-5L (EuroQol health states) questionnaire score
The quality of life will be assessed using the EQ-5D-5L questionnaire (EuroQol health states)
Measured: On day 1 (inclusion) and on day 56 (end of patient follow-up)
Visual Analogue Scale and Adverse Events grades (Benefit / risk balance)
To simultaneously compare the VAS (Visual Analogue Scale) and the relevant adverse events (AE) grades between groups.
This benefit-risk balance will be estimate in a hierarchical fashion using the method of pairwise comparisons. The VAS will be used as the first endpoint (benefit) and the highest grade of AE in a given patient as the second endpoint (risk). No clinical relevance threshold will be specified for the two criteria for the primary analysis, but they will then be added as a sensitivity analysis.
Measured: Until day 56 (end of patient follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start5 Nov 2021
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650074
- Sponsor's protocol ID
- 69HCL18_0996
- Acronym
- MESO-SDRC
- Status last verified
- May 2024
- First submitted
- 25 Nov 2020
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lafuma P, Magaud L, Abichou-Klich A, Rabilloud M, Wegrzyn J, Baude C, Rippert P, Kaou M, Haesebaert J, Rongieras F, Marchand C, Dhelens C, Febvey-Combes O. Mesotherapy With Lidocaine and Ketamine in Complex Regional Pain Syndrome Type 1: A Randomized Double-Blind Trial. Pain Pract. 2026 Sep;26(7):e70187. doi: 10.1111/papr.70187.
PubMed 42421175
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Effectiveness of a Mixture of Ketamine / Lidocaine Administered by Mesotherapy in the Management of Neuropathic Pain in Complex Regional Pain Syndrome Type 1 (CRPS1). A Monocentric Randomized and Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04650074
- Acronym / sponsor ID
- MESO-SDRC / 69HCL18_0996
- Keywords
- Complex Regional Pain Syndrome Type 1, Mesotherapy, Lidocaïne, Ketamine, Randomized clinical trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 2 Dec 2020 (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.
Complex Regional Pain Syndrome type 1 (CRPS1) is a disabling pain syndrome. Its definitive treatment has not been established and the results of current treatments are often unsatisfactory.
The prognosis is difficult to establish because the vast majority of CRPS regresses within a few weeks. However, some forms are hyperalgesic with a major chronic painful picture, very debilitating and responding poorly to treatments with possible permanent sequelae.
The management of CRPS remains difficult and unsatisfactory and is symptomatic, multidimensional and multidisciplinary involving medical, paramedical and socio-professional workers. The priority therapeutic objectives are analgesia, maintenance or gain of joint range and maintenance or restoration of motor functions. This treatment is not the subject of a consensus and its implementation is sometimes the responsibility of specialized centers such as "pain relief" centers or even Physical Medicine and Rehabilitation (MPR) structures.
Previous studies using ketamine as a treatment for CRPS1 show encouraging results with a decrease in neuropathic pain. Ketamine is a low dose pain reliever. Ketamine has been studied as an adjuvant for the treatment of chronic pain, particularly neuropathic pain. The results suggest that ketamine decreases pain intensity and reduces opioid reliance when used as an adjunct to chronic and acute pain. Ketamine is believed to have a greater analgesic effect in patients with CRPS1 compared to other chronic pain syndromes. In these studies, ketamine was used intravenously, subcutaneously, orally, intranasally, or topically.
Mesotherapy allows microdose local treatment to be carried out limiting side effects, ensuring compliance and easy to implement. The injected solutions often contain a local anesthetic (procaine or lidocaine). It allows better local tolerance from the start of treatment. In addition, through its vasodilator effect on the microcirculation, it increases the effectiveness and tolerance of other injected products.
There are no studies using ketamine administrated by mesotherapy. Based on the scientific literature, there are good reasons to believe that this treatment could be effective on the neuropathic pain of CRPS1 and well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LIDOCAINE 20 mg | Active comparator | Drug: LIDOCAINE 20 mg4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine (qsp 6 ml NaCl 0.9%). |
| LIDOCAINE 20 mg + KETAMINE 20 mg | Experimental | Drug: LIDOCAINE 20 mg + KETAMINE 20 mg4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine + 20 mg Ketamine (qsp 6 ml NaCl 0.9%). |
| LIDOCAINE 20 mg + KETAMINE 40 mg | Experimental | Drug: LIDOCAINE 20 mg + KETAMINE 40 mg4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine + 40 mg Ketamine (qsp 6 ml NaCl 0.9%). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male / female aged ≥18 years,
- Patient suffering from Complex Regional Pain Syndrome Type 1 (CRPS1), according to the Budapest criteria, with a neuropathic component limited to the lower or upper limbs diagnosed by the Neuropathic pain DN4 Questionnaire
- Patient having undergone a three-stage dynamic bone scan less than 3 months old : vascular, tissue, bone, showing diffuse and extensive hyperfixation in the area suspected of CRPS1,
- Negative urinary pregnancy test in women of childbearing age,
- VAS (Visual Analogue Scale) > 50mm (on a scale of 0 to 100 mm) at inclusion,
Key exclusion criteria (12 listed)
- Patient with the following medical history or ongoing pathologies: epilepsy, hypertension (> 180mm / 100mm Hg), unbalanced coronary artery disease, recent myocardial infarction (MDI) (less than 12 months), porphyria, hyperthyroidism, known Behçet's disease, known blood crass disorder or PT (Prothrombin Time) <20%, known psychiatric disorders, known septic osteoarticular disease,
- Patient with HIV ((Human Immunodeficiency Viruses) infection, immunosuppression and / or immunosuppressive treatment
- Severe heart failure,
- History of severe allergy (angioedema),
- Known allergies to Cr and Zn,
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 |
|---|---|---|
| LIDOCAINE 20 mg4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine (qsp 6 ml NaCl 0.9%). Each mesotherapy session includes 2 steps performed chronologically. It will be done within 2 or 3 minutes each one: * 1st sequence: intra-epidermal injections of 3 ml by manual technique in crossed lines with a 13 mm x 0.30 needle, * 2nd sequence : superficial intradermal injections of 3 ml (between 1 and 2 mm) using a technique assisted by a Pistor Eliance injector at a frequency of 200 punctures per minute. | Drug | LIDOCAINE 20 mg |
| LIDOCAINE 20 mg + KETAMINE 20 mg4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine + 20 mg Ketamine (qsp 6 ml NaCl 0.9%). Each mesotherapy session includes 2 steps performed chronologically. It will be done within 2 or 3 minutes each one: * 1st sequence: intra-epidermal injections of 3 ml by manual technique in crossed lines with a 13 mm x 0.30 needle, * 2nd sequence : superficial intradermal injections of 3 ml (between 1 and 2 mm) using a technique assisted by a Pistor Eliance injector at a frequency of 200 punctures per minute. | Drug | LIDOCAINE 20 mg + KETAMINE 20 mg |
| LIDOCAINE 20 mg + KETAMINE 40 mg4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine + 40 mg Ketamine (qsp 6 ml NaCl 0.9%). Each mesotherapy session includes 2 steps performed chronologically. It will be done within 2 or 3 minutes each one: * 1st sequence: intra-epidermal injections of 3 ml by manual technique in crossed lines with a 13 mm x 0.30 needle, * 2nd sequence : superficial intradermal injections of 3 ml (between 1 and 2 mm) using a technique assisted by a Pistor Eliance injector at a frequency of 200 punctures per minute | Drug | LIDOCAINE 20 mg + KETAMINE 40 mg |
Primary outcome
Visual Analogue Scale (VAS) score
Time frame: On day 0 (inclusion) and day 56 (end of patient follow-up)
Pain measured by VAS (Visual Analogue Scale)
7 secondary outcomes
Evolution of the Visual Analogue Scale score
Time frame: On day 0 (inclusion), on day 1, day 7, day 14 and day 28 (mesotherapy sessions), and on day 56 (end of patient follow-up)
Neuropathic Pain Symptom Inventory (NPSI) self-questionnaire score
Time frame: On day 0 (inclusion), on day 1, day 7, day 14 and day 28 (mesotherapy sessions), and on day 56 (end of the patient follow-up)
Brief Pain Inventory (BPI) self-questionnaire score
Time frame: On day 0 (inclusion) and on day 56 (end of patient follouw-up)
Relevant adverse events
Time frame: Until day 56 (end of patient follow-up)
Concomitant consumption of analgesics
Time frame: Until day 56 (end of patient follow-up)
EQ-5D-5L (EuroQol health states) questionnaire score
Time frame: On day 1 (inclusion) and on day 56 (end of patient follow-up)
Visual Analogue Scale and Adverse Events grades (Benefit / risk balance)
Time frame: Until day 56 (end of patient follow-up)
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 10 Aug 2026.
- Results publication: PubMed 42421175Lafuma P, Magaud L, Abichou-Klich A, Rabilloud M, Wegrzyn J, Baude C, Rippert P, Kaou M, Haesebaert J, Rongieras F, Marchand C, Dhelens C, Febvey-Combes O. Mesotherapy With Lidocaine and Ketamine in Complex Regional Pain Syndrome Type 1: A Randomized Double-Blind Trial. Pain Pract. 2026 Sep;26(7):e70187. doi: 10.1111/papr.70187.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 LIDOCAINE 20 mg, LIDOCAINE 20 mg + KETAMINE 20 mg and LIDOCAINE 20 mg + KETAMINE 40 mg in people with Neuropathic Pain and Complex Regional Pain Syndrome Type 1, run by Hospices Civils de Lyon at 1 site in France.
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 7 inclusion and 12 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 10 Aug 2026. 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 France. 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?
Visual Analogue Scale (VAS) score (time frame: On day 0 (inclusion) and day 56 (end of patient follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04650074, which also lists 1 linked publication.
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 10 Aug 2026.