Lateral EpicondylitisPhase 2/3MILESNCT04201249
Mesotherapy In Lateral Epicondylitis
A Phase 2/3 study testing Piroxicam, lidocaine and Mesotherapy without drug administration in people with Lateral Epicondylitis, run by Hospital de Santa Maria, Portugal at 1 site in Portugal.
Trial summary
Investigate the short- and long-term efficacy and safety of intradermal NSAIDs and lidocaine (delivered through mesotherapy) for the treatment of LE comparing it with empty intradermal injections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Piroxicam, lidocaine and Mesotherapy without drug administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Dec 2019to 12 Dec 2021
- 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
- clinical diagnosis defined as pain over the lateral epicondyle provoked by palpation;
- A visual analogue scale (VAS) score for pain greater than 40mm;
- symptoms duration for more than 1 month.
Who cannot join
- other diseases that can alter clinical evaluation detected through history, clinical examination, ultrasound or other exams for comorbidities such as carpal tunnel syndrome, cervical radiculopathy, elbow arthritis, intra-articular loose bodies, previous elbow surgery or clinically significant or recent trauma, fibromyalgia and major psychiatric conditions;
- VAS score for pain less than 40mm;
- any of the following treatments during the previous 4 weeks before baseline visit: physical therapy, bandage, mesotherapy and local corticosteroid injection or a combination of these: NSAIDS taken during the week previous to inclusion;
- pregnancy;
- allergy to any of the study drugs;
- severely immunosuppressed patients;
- known coagulopathies. During the study period, enrolled patients are not allowed to take oral corticosteroids, NSAIDs or receive any other medical intervention during the treatment period (physical therapy, bandage, mesotherapy and local corticosteroid injection or a combination of these).
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Hospital de Santa Maria
Lisbon
Vítor AS Teixeira, 918219891 ext. 00351, vitor.as.teixeira@gmail.com
About this study
Official title: MILES STUDY - Mesotherapy In Lateral Epicondylitis, a Prospective Randomized Controlled Study
Investigate the short- and long-term efficacy and safety of intradermal NSAIDs and lidocaine (delivered through mesotherapy) for the treatment of LE comparing it with empty intradermal injections.
- Conditions
- Lateral Epicondylitis
- Being tested
- Piroxicam, lidocaine, Mesotherapy without drug administration
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piroxicam, lidocaineDrug
Patients will be randomized to 2 groups group A - mesotherapy with piroxicam (20mg/ml, 1ml) and lidocaine (1%, 1.5ml) (treatment arm); group group B - mesotherapy without piroxicam
Mesotherapy without drug administrationDevice
Patients will be randomized to 2 groups group A - mesotherapy with piroxicam (20mg/ml, 1ml) and lidocaine (1%, 1.5ml) (treatment arm); group group B - mesotherapy without piroxicam
| Study group | Role | What they receive |
|---|---|---|
| Mesotherapy with piroxicam and lidocaine | Active comparator | Not described Receives: Drug: Piroxicam, lidocaine |
| Mesotherapy without piroxicam and lidocaine | Sham comparator | Not described Receives: Device: Mesotherapy without drug administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity: visual analogue scale score
pain intensity quantified by using a 0-100 visual analogue scale (VAS) score; a higher score means a higher pain intensity on the VAS
Measured: 3 months
Secondary outcomes (1)
Clinical and functional evaluation
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES-E) score, ranging from 0 to 5 in strenght assessment (0=no contraction; 1=flicker; 2=movement with gravity eliminated; 3=movement against gravity; 4=movement with some resistance; 5=normal power) and from 0-3 in the stability section (0=no instability; 1=mild laxity with good endpoint; 2=moderate laxity no endpoint;3=gross instability)
Measured: 0, 1, 2, 3 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Dec 2019
- Primary completion12 Dec 2021 (estimated)
- Study completion12 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Santa Maria, Portugal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vítor Teixeira, Hospital de Santa Maria, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201249
- Sponsor's protocol ID
- MILES
- Acronym
- MILES
- Status last verified
- Dec 2019
- First submitted
- 11 Dec 2019
- Last updated
- 18 Dec 2019
- 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 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MILES STUDY - Mesotherapy In Lateral Epicondylitis, a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04201249
- Acronym / sponsor ID
- MILES / MILES
- Conditions
- Lateral Epicondylitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Hospital de Santa Maria, PortugalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 12 Dec 2021 (estimated)
- Study completion
- 12 Dec 2021 (estimated)
- First posted
- 17 Dec 2019 (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.
Investigate the short- and long-term efficacy and safety of intradermal NSAIDs and lidocaine (delivered through mesotherapy) for the treatment of LE comparing it with empty intradermal injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesotherapy with piroxicam and lidocaine | Active comparator | Drug: Piroxicam, lidocaine |
| Mesotherapy without piroxicam and lidocaine | Sham comparator | Device: Mesotherapy without drug administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis defined as pain over the lateral epicondyle provoked by palpation;
- A visual analogue scale (VAS) score for pain greater than 40mm;
- symptoms duration for more than 1 month.
Key exclusion criteria (7 listed)
- other diseases that can alter clinical evaluation detected through history, clinical examination, ultrasound or other exams for comorbidities such as carpal tunnel syndrome, cervical radiculopathy, elbow arthritis, intra-articular loose bodies, previous elbow surgery or clinically significant or recent trauma, fibromyalgia and major psychiatric conditions;
- VAS score for pain less than 40mm;
- any of the following treatments during the previous 4 weeks before baseline visit: physical therapy, bandage, mesotherapy and local corticosteroid injection or a combination of these: NSAIDS taken during the week previous to inclusion;
- pregnancy;
- allergy to any of the study drugs;
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 |
|---|---|---|
| Piroxicam, lidocainePatients will be randomized to 2 groups group A - mesotherapy with piroxicam (20mg/ml, 1ml) and lidocaine (1%, 1.5ml) (treatment arm); group group B - mesotherapy without piroxicam | Drug | Mesotherapy with piroxicam and lidocaine |
| Mesotherapy without drug administrationPatients will be randomized to 2 groups group A - mesotherapy with piroxicam (20mg/ml, 1ml) and lidocaine (1%, 1.5ml) (treatment arm); group group B - mesotherapy without piroxicam | Device | Mesotherapy without piroxicam and lidocaine |
Primary outcome
Pain intensity: visual analogue scale score
Time frame: 3 months
pain intensity quantified by using a 0-100 visual analogue scale (VAS) score; a higher score means a higher pain intensity on the VAS
1 secondary outcome
Clinical and functional evaluation
Time frame: 0, 1, 2, 3 weeks and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruitingObservational study
Metabolic and Inflammatory Indices in Lateral Epicondylitis
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
Not yet recruiting
Effectiveness of Topical Chinese Medicine Ointment Therapy (TCMO) (Ng's Prescription) Eccentric Exercise for Tennis Elbow as Control: a Randomized Controlled Trial.
Lateral Epicondylitis, TCMO (Ng's Prescription)
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.
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 Piroxicam, lidocaine and Mesotherapy without drug administration in people with Lateral Epicondylitis, run by Hospital de Santa Maria, Portugal at 1 site in Portugal.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Dec 2019. 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 Portugal. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vitor AS Teixeira (918219891 ext. 00351, vitor.as.teixeira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity: visual analogue scale score (time frame: 3 months). 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 18 Dec 2019.