Management of Popeye Sign With Botulinum Toxin After Bicepstenotomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Management of Popeye Sign With Botulinum Toxin After Tenotomy of the Long Head of the Biceps Tendon: a Double-blinded Randomized Controlled Trial

Conditions
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Popeye Syndrome

Intervention / Treatment
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* Drug: Botulinum toxin type A
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Have had arthroscopic tenotomy of the long head of the biceps tendon without rotator cuff repair, acromioclavicular joint resection or glenoid labrum repair Having bicipital pain that started after the tenotomy Exclusion Criteria: under 18 years of age over 65 years of age pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin<br>Infiltration with botulinum toxin | Drug: Botulinum toxin type A<br>* 1 infiltration in the biceps muscle with botulinum toxin (100 IU)<br>|
| Placebo Comparator: Placebo<br>Infiltration with placebo or sterile saline | Other: Placebo<br>* 1 infiltration in the biceps muscle with placebo or sterile saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain change | VAS score: Visual Analogue Scale score of 0 to 10 with 0 indicating no pain and 10 the worst pain imaginable | 3 months | 
| Disability change | quick DASH: Disabilities of the Arm, Shoulder and Hand 0 (no disability) to 100 (most severe disability) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tenotomy, long head of the biceps tendon, botulinum toxin