Study of the Treatment of Tendinopathy Unruptured of Rotator Cuff by Intramuscular Injection of Botulinum Toxin
Overview
- Phase
- Phase 2
- Intervention
- Botox arm
- Conditions
- Tendinopathy Rotator Cuff
- Sponsor
- Versailles Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 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.
- Last Updated
- 9 years ago
Overview
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.
Investigators
Nicolas Pujol
Investigator coordinator
Versailles Hospital
Eligibility Criteria
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
Arms & Interventions
Botox arm
intramuscular injection of botulinum toxin
Intervention: Botox arm
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Significant improvement in life quality : functional clinical scores (Constant, ASES, Oxford)(24 months)