Phase
Condition
N/ATreatment
AbobotulinumtoxinA
Placebo
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Baseline Comparator Group:
Inclusion Criteria:
Adult male and female runners aged 18-65 years
Group providing normative values for SWE and needle manometry - ICP assessments
Exclusion
Exclusion Criteria:
- History of Neuromuscular disease, serious soft-tissue injury, fractures, and surgeryto the lower limb(s).
Treatment Groups:
Inclusion Criteria:
Confirmatory pressure values at diagnosis: Pre-exercise > 15mmHg; 1-min. post > 30mmHg; or, 5-min. post > 20mmHg
Ages 18-65 years inclusive at study onset.
Ability to adhere to protocol.
Pain level on the VAS of >=6/10 during baseline visit assessed immediately after atreadmill run
An established physiotherapy and/or orthotic regimen will be permitted provided thatit began > 4 weeks before the study start and is maintained throughout the study.
Botulinum toxin naïve (lower extremity). Others previously treated, > than 6 mos.prior to study entry.
Exclusion Criteria:
Diagnosis of comorbid pain conditions including claudication and/or popliteal arteryentrapment syndrome.
Serious soft tissue injury, fractures, or surgery in the lower limb(s) < than12months prior to study entry.
Current need for surgery at any level of the lower extremity.Without a history ofNeuromuscular disease, serious soft-tissue injury, fractures, and surgery to thelower limb(s).
Treatment with any drug known to interfere with neuromuscular function (e.g.:aminoglycoside antibiotics or neuromuscular blocking agents).
Any other medical condition, laboratory, or diagnostic procedure finding that mightpreclude the administration of aboBoNTA (Dysport®).
Ongoing infection at the injection sites.
Diagnosed as either resistant or sensitive to botulinum toxin treatment of any typeor to any components of Dysport®
Cow milk protein allergy.
Vulnerable patient populations such as adults unable to consent, pregnant women,prisoners, persons who have not obtained the legal age for consent to treatment orprocedures
Study Design
Study Description
Connect with a study center
Emory Sports Medicine-Dunwoody
Atlanta, Georgia 30338
United StatesActive - Recruiting
Emory Hawks Sports Medicine Center
Brookhaven, Georgia 30329
United StatesActive - Recruiting
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