NCT04750291

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

August 9, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

1.3 years

First QC Date

February 8, 2021

Last Update Submit

October 15, 2021

Conditions

Popeye Syndrome

Keywords

tenotomylong head of the biceps tendonbotulinum toxin

Outcome Measures

Primary Outcomes (2)

  • 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

  • Disability change

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

    3 months

Study Arms (2)

Botulinum toxin

EXPERIMENTAL

Infiltration with botulinum toxin

Drug: Botulinum toxin type A

Placebo

PLACEBO COMPARATOR

Infiltration with placebo or sterile saline

Other: Placebo

Interventions

Botulinum toxin type ADRUG

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

Botulinum toxin
PlaceboOTHER

1 infiltration in the biceps muscle with placebo or sterile saline

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • under 18 years of age
  • over 65 years of age
  • pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Delta

Roeselare, 8800, Belgium

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Bert Vanmierlo, MD

    Orthopedie Roeselare AZ Delta

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pieter Van Geel, MD

CONTACT

+32474322540pivangeel@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 11, 2021

Study Start

August 9, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)