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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02867787
Other study ID # P13/09_ Botox
Secondary ID
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


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
See also
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