Management of Popeye Sign With Botulinum Toxin After Bicepstenotomy
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- STATUS
- Recruiting
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- End date
- Dec 30, 2022
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- participants needed
- 20
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- sponsor
- AZ Delta
Summary
Double-blinded randomized controlled trial with 20 people of whom 10 will receive a placebo infiltration and 10 an infiltration with botulinum toxin type A for cramping pain after arthroscopic tenotomy of the long head of the biceps tendon.
Description
Title: Management of Popeye sign with botulinum toxin after tenotomy of the long head of the biceps tendon: a double-blinded randomized controlled trial Prcis: Double-blinded randomized controlled trial with 20 people. Randomization in 2 arms of 10 people. 3 visits will be planned with a meantime of 3 months after the infiltration with botulinum toxin type A (BTX-A) or placebo that will be administered at the 2nd visit.
Objective: The primary objective is to assess the effectiveness of an infiltration with botulinum toxin in the biceps muscle after tenotomy of the long head of the biceps tendon for pain and disability reduction.
Endpoint: The primary endpoint is a pain reduction as measured by the Visual Analogue pain scale (VAS) and a reduced disability as measured by the quick DASH (Disabilities of the Arm, Shoulder and Hand).
Population: 20 people who underwent an arthroscopic tenotomy of the long head of the biceps tendon and are having post-operative pain in the biceps muscle.
Phase: 4
Number of Sites enrolling participants: single center study in AZ Delta Roeselare
Description of Study Agent: botulinum toxin type A (Botox) 100 International Units by intramuscular injection
Study Duration: From March 2021 till December 2022
Participant Duration: 3 months
Details
| Condition | Popeye Syndrome |
|---|---|
| Treatment | Placebo, Botulinum Toxin Type A |
| Clinical Study Identifier | NCT04750291 |
| Sponsor | AZ Delta |
| Last Modified on | 30 October 2021 |
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