Management of Popeye Sign With Botulinum Toxin After Bicepstenotomy

• Sponsor: AZ Delta (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04750291
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.7
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Popeye Syndrome	Drug: Botulinum toxin type A; Other: Placebo	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 9, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botulinum toxin Infiltration with botulinum toxin	Drug: Botulinum toxin type A; 1 infiltration in the biceps muscle with botulinum toxin (100 IU)
Placebo Comparator: Placebo Infiltration with placebo or sterile saline	Other: Placebo; 1 infiltration in the biceps muscle with placebo or sterile saline

Outcome Measures

Primary Outcome Measures

1. 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

2. Disability change [3 months]

   quick DASH: Disabilities of the Arm, Shoulder and Hand 0 (no disability) to 100 (most severe disability)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AZ Delta	Roeselare		Belgium	8800

Sponsors and Collaborators

• AZ Delta

Investigators

• Principal Investigator: Bert Vanmierlo, MD, Orthopedie Roeselare AZ Delta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bert VanMierlo, Principal Investigator, AZ Delta
• ClinicalTrials.gov Identifier: NCT04750291
• Other Study ID Numbers: 12217
• First Posted: Feb 11, 2021
• Last Update Posted: Oct 22, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Bert VanMierlo, Principal Investigator, AZ Delta: tenotomy; long head of the biceps tendon; botulinum toxin
• Additional relevant MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

No Results Posted as of Oct 22, 2021