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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02867787

Acronym

Botox shoulder

Enrollment

Registered

2016-08-16

Start date

2014-03-31

Completion date

2016-09-30

Last updated

2016-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendinopathy Rotator Cuff

Keywords

Shoulder Joint, A02.835.583.748

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.

Interventions

DRUGBotox arm

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Significant improvement in life quality : functional clinical scores (Constant, ASES, Oxford)	24 months

Countries

France

Contacts

Primary ContactMorisset Laure

lmorisset@ch-versailles.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026