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Study of the Treatment of Tendinopathy Unruptured of Rotator Cuff by Intramuscular Injection of Botulinum Toxin (Botox shoulder)

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ClinicalTrials.gov Identifier: NCT02867787
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Nicolas Pujol, Versailles Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Tendinopathy Rotator Cuff Drug: Botox arm Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Tendinitis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Botox arm
intramuscular injection of botulinum toxin
Drug: Botox arm



Primary Outcome Measures :
  1. Significant improvement in shoulder pain objectified by analogy Visual Scale (VAS) in patients with unruptured tendinopathy of the rotator cuff impingement, debilitating, lasting for more than 3 months and resistant to usual medical treatment. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Significant improvement in life quality : functional clinical scores (Constant, ASES, Oxford) [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867787


Contacts
Contact: Morisset Laure lmorisset@ch-versailles.fr

Locations
France
CH Versailles Recruiting
Le CHESNAY, France, 78150
Contact: Pujol Nicolas, MD         
Contact: Morisset Laure         
Sponsors and Collaborators
Versailles Hospital
Investigators
Principal Investigator: Pujol Nicolas, MD CH Versailles

Responsible Party: Nicolas Pujol, Investigator coordinator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT02867787     History of Changes
Other Study ID Numbers: P13/09_ Botox
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016

Keywords provided by Nicolas Pujol, Versailles Hospital:
Shoulder Joint
A02.835.583.748

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs