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Management of Popeye Sign With Botulinum Toxin After Bicepstenotomy

NCT ID: NCT04750291

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-09

Study Completion Date

2022-12-31

Brief Summary

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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

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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

Conditions

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Popeye Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Botulinum toxin

Infiltration with botulinum toxin

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type DRUG

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

Placebo

Infiltration with placebo or sterile saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

1 infiltration in the biceps muscle with placebo or sterile saline

Interventions

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Botulinum toxin type A

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

Intervention Type DRUG

Placebo

1 infiltration in the biceps muscle with placebo or sterile saline

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AZ Delta

OTHER

Sponsor Role lead

Responsible Party

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Bert VanMierlo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bert Vanmierlo, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopedie Roeselare AZ Delta

Locations

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AZ Delta

Roeselare, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Pieter Van Geel, MD

Role: CONTACT

[email protected]
+32474322540

Facility Contacts

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Pieter Van Geel, MD

Role: primary

Other Identifiers

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12217

Identifier Type: -

Identifier Source: org_study_id