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

V

Versailles Hospital

Status and phase

Unknown
Phase 2

Conditions

Tendinopathy Rotator Cuff

Treatments

Drug: Botox arm

Study type

Interventional

Funder types

Other

Identifiers

NCT02867787
P13/09_ Botox

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Botox arm
Experimental group
Description:
intramuscular injection of botulinum toxin
Treatment:
Drug: Botox arm

Trial contacts and locations

1

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Central trial contact

Morisset Laure

Data sourced from clinicaltrials.gov

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