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

Tendinopathy Rotator Cuff Clinical Trial

— Botox shoulder  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02867787
• Other study ID #: P13/09_ Botox
• Status: Recruiting
• Phase: Phase 2
• First received: August 11, 2016
• Last updated: August 17, 2016
• Start date: March 2014
• Est. completion date: September 2016

Study information

• Verified date: August 2016
• Source: Central Hospital, Versailles
• Contact: Morisset Laure
• Email: lmorisset[@]ch-versailles.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tendinopathy
• Tendinopathy Rotator Cuff

Intervention

Drug:
• Botox arm

Locations

Country	Name	City	State
France	CH Versailles	Le CHESNAY

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Versailles

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 months	No
Secondary	Significant improvement in life quality : functional clinical scores (Constant, ASES, Oxford)		24 months	No