Management of Popeye Sign With Botulinum Toxin After Bicepstenotomy

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04750291

Enrollment

Registered

2021-02-11

Start date

2021-08-09

Completion date

2022-12-31

Last updated

2021-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Popeye Syndrome

Keywords

tenotomy, long head of the biceps tendon, botulinum toxin

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

Interventions

DRUGBotulinum toxin type A

1 infiltration in the biceps muscle with botulinum toxin (100 IU)

OTHERPlacebo

1 infiltration in the biceps muscle with placebo or sterile saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

Belgium

Contacts

Primary ContactPieter Van Geel, MD

pivangeel@gmail.com+32474322540

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026