Management of Popeye Sign With Botulinum Toxin After Bicepstenotomy

Phase 4

• Conditions: Popeye Syndrome
• Interventions: Other: Placebo; Drug: Botulinum toxin type A

• Registration Number: NCT04750291
• Lead Sponsor: AZ Delta

Brief 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.

Detailed 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 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

Study Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-11
• Study Start: 2021-08-09
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-22
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Infiltration with placebo or sterile saline
Botulinum toxin	Botulinum toxin type A	Infiltration with botulinum toxin

Primary Outcome Measures

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

Trial Locations

Locations (1)

AZ Delta; 🇧🇪 Roeselare, Belgium