Management of Popeye Sign With Botulinum Toxin After Bicepstenotomy

Popeye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04750291
• Other study ID #: 12217
• Status: Recruiting
• Phase: Phase 4
• Start date: August 9, 2021
• Est. completion date: December 2022

Study information

• Verified date: October 2021
• Source: AZ Delta
• Contact: Pieter Van Geel, MD
• Phone: +32474322540
• Email: pivangeel[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Popeye Syndrome

Intervention

Drug:
• Botulinum toxin type A
1 infiltration in the biceps muscle with botulinum toxin (100 IU)

Other:
• Placebo
1 infiltration in the biceps muscle with placebo or sterile saline

Locations

Country	Name	City	State
Belgium	AZ Delta	Roeselare

Sponsors (1)

Lead Sponsor	Collaborator
AZ Delta

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Disability change	quick DASH: Disabilities of the Arm, Shoulder and Hand 0 (no disability) to 100 (most severe disability)	3 months