A Phase 4 interventional study of Botulinum toxin type A and Placebo in Popeye Syndrome, sponsored by AZ Delta. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-22.
Sponsored by AZ Delta · Phase 4, Interventional, and Treatment
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.
Title: Management of Popeye sign with botulinum toxin after tenotomy of the long head of the biceps tendon: a double-blinded randomized controlled trial Précis: 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
AZ Delta is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infiltration with botulinum toxin
Drug: Botulinum toxin type A
Infiltration with placebo or sterile saline
Other: Placebo
1 infiltration in the biceps muscle with botulinum toxin (100 IU)
1 infiltration in the biceps muscle with placebo or sterile saline
Pain change
VAS score: Visual Analogue Scale score of 0 to 10 with 0 indicating no pain and 10 the worst pain imaginable
Time frame: 3 months
Disability change
quick DASH: Disabilities of the Arm, Shoulder and Hand 0 (no disability) to 100 (most severe disability)
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2021 (actual). Primary completion is estimated for Dec 2022, 16 months after the start.
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This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A
AZ Delta