Study of the Treatment of Tendinopathy Unruptured of Rotator Cuff by Intramuscular Injection of Botulinum Toxin

NCT ID: NCT02867787

Last Updated: 2016-08-18

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

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-09-30

Brief Summary

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Botulinum toxin is used in musculoskeletal therapy routinely for 15 years. This is one of the most potent neurotoxins. It comes in 7 serotypes (A to G).Therapeutic application of botulinum toxin are mainly based on its ability to block the neuromuscular transmission by preventing the release of acetylcholine, creating paralysis muscle relative and reversible.

It has been used in the treatment of cervical dystonia, migraine headaches, and an antinociceptive effect. The analgesic effect occurred even prior to the release muscular. Several randomized studies have been published about it. The investigators assume that intramuscular injection of botulinum toxin is effective in the treatment of tendinopathy rotator cuff.

Detailed Description

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Conditions

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Tendinopathy Rotator Cuff

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Botox arm

intramuscular injection of botulinum toxin

Group Type EXPERIMENTAL

Botox arm

Intervention Type DRUG

Interventions

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Botox arm

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed consent
* Active social care
* Compliant patient with protocol
* Patient more than 18 years
* Positive Neer Test

Exclusion Criteria

* Prior study exclusion period
* Protected patient
* Study refusal
* Deficient patient
* Rheumatoid arthritis, osteoarthritis, chondrocalcinosis.
* Microcrystalline arthritis.
* Active infection .
* History of hypersensitivity reaction during a previous injection of botulinum toxin
* Bilateral involvement
* Neurological deficit
* Depression
* History of shoulder surgery
* Pregnant or breast feeding women
* Systemic disease (diabeta, vascularitis)
* Known neurological disease
* Intraarticular associate disease
* Acromioclavicular associate disease
* Myasthenia
* Botulinum toxin is not recommended in combination with aminoglycosides
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Versailles Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nicolas Pujol

Investigator coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pujol Nicolas, MD

Role: PRINCIPAL_INVESTIGATOR

CH Versailles

Locations

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CH Versailles

Le Chesnay, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Morisset Laure

Role: CONTACT

Facility Contacts

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Pujol Nicolas, MD

Role: primary

Morisset Laure

Role: backup

Other Identifiers

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P13/09_ Botox

Identifier Type: -

Identifier Source: org_study_id

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