Lateral Epicondylitis
Conditions
Brief 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.
Interventions
DRUGPiroxicam, lidocaine
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
DEVICEMesotherapy without drug administration
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
Sponsors
Hospital de Santa Maria, Portugal
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity: visual analogue scale score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and functional evaluation | 0, 1, 2, 3 weeks and 6 months | 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) |
Countries
Portugal
Contacts
Primary ContactVitor AS Teixeira
Outcome results
None listed