Comparison of injection with botulinum toxine or placebo (sterile saline) in the biceps muscle for cramping pain after biceps tenotomy

Management of Popeye sign with botulinum toxin after tenotomy of the long head of the biceps tendon: a double-blinded randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005547-23-BE

Enrollment

Registered

2021-04-19

Start date

2021-07-22

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Popeye sign or cramping pain after shoulder artroscopy with biceps tenotomy

Interventions

Trade Name: Botox Product Name: Botulinum toxin type A Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Botulinum toxin type A - 100 IU CAS Number: 93384-43-1 Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - under 18 years of age - over 65 years of age - pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: Pain reduction Disability reduction;Secondary Objective: Not applicable;Primary end point(s): Pain reduction (VAS) Disability reduction (quick DASH);Timepoint(s) of evaluation of this end point: 3 months	—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactClinical Trial Center

AZ Delta

ctc@azdelta.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026