A Phase 2/3 interventional study of Piroxicam, lidocaine and Mesotherapy without drug administration in Lateral Epicondylitis, sponsored by Hospital de Santa Maria, Portugal. Status unknown at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-18.
Sponsored by Hospital de Santa Maria, Portugal · Phase 2/3, Interventional, and Treatment
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.
296 studies on the registry are indexed under Tennis Elbow; 64 are open to participants now.
This study's planned enrollment of 82 is above the median of 50 across 262 interventional studies indexed under Tennis Elbow.
Browse Tennis Elbow studies →Hospital de Santa Maria, Portugal is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Clinically significant
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Immunosuppression
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Drug: Piroxicam, lidocaine
Device: Mesotherapy without drug administration
Drug pages: Piroxicam · 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
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
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
Time frame: 3 months
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)
Time frame: 0, 1, 2, 3 weeks and 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2019 (actual). Primary completion is estimated for Dec 2021, 24 months after the start.
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This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Piroxicam · Lidocaine
Hospital de Santa Maria, Portugal