COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02867787
Recruitment Status : Unknown
Verified August 2016 by Nicolas Pujol, Versailles Hospital.
Recruitment status was:  Recruiting
First Posted : August 16, 2016
Last Update Posted : August 18, 2016
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT02867787

Layout table for location contacts
Contact: Morisset Laure

Layout table for location information
CH Versailles Recruiting
Le CHESNAY, France, 78150
Contact: Pujol Nicolas, MD         
Contact: Morisset Laure         
Sponsors and Collaborators
Versailles Hospital
Layout table for investigator information
Principal Investigator: Pujol Nicolas, MD CH Versailles
Layout table for additonal information
Responsible Party: Nicolas Pujol, Investigator coordinator, Versailles Hospital Identifier: NCT02867787    
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries