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 : Unknown
Verified August 2016 by Nicolas Pujol, Versailles Hospital.
Recruitment status was: Recruiting
First Posted : August 16, 2016
Last Update Posted : August 18, 2016
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)|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2016|
Experimental: Botox arm
intramuscular injection of botulinum toxin
Drug: Botox arm
- 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 ]
- Significant improvement in life quality : functional clinical scores (Constant, ASES, Oxford) [ Time Frame: 24 months ]
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
|Contact: Morisset Laurefirstname.lastname@example.org|
|Le CHESNAY, France, 78150|
|Contact: Pujol Nicolas, MD|
|Contact: Morisset Laure|
|Principal Investigator:||Pujol Nicolas, MD||CH Versailles|