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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesotherapy with piroxicam and lidocaine | Active Comparator |
| |
| Mesotherapy without piroxicam and lidocaine | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piroxicam, lidocaine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vitor AS Teixeira | Contact | 918219891 | 00351 | vitor.as.teixeira@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Santa Maria | Recruiting | Lisbon | Portugal |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D010894 | Piroxicam |
| D008012 | Lidocaine |
| D057748 | Mesotherapy |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Mesotherapy without drug administration | Device | 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 |
|
| 0, 1, 2, 3 weeks and 6 months |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D006571 |
| Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D003357 | Cosmetic Techniques |
| D007279 | Injections, Subcutaneous |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |