Study of the Treatment of Tendinopathy Unruptured of Rotator Cuff by Intramuscular Injection of Botulinum Toxin
Botox shoulder
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 11, 2016
CompletedFirst Posted
Study publicly available on registry
August 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedAugust 18, 2016
August 1, 2016
2.5 years
August 11, 2016
August 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Significant improvement in life quality : functional clinical scores (Constant, ASES, Oxford)
24 months
Study Arms (1)
Botox arm
EXPERIMENTALintramuscular injection of botulinum toxin
Interventions
Eligibility Criteria
You may qualify if:
- Signed consent
- Active social care
- Compliant patient with protocol
- Patient more than 18 years
- Positive Neer Test
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CH Versailles
Le Chesnay, 78150, France
Study Officials
- PRINCIPAL INVESTIGATOR
Pujol Nicolas, MD
CH Versailles
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator coordinator
Study Record Dates
First Submitted
August 11, 2016
First Posted
August 16, 2016
Study Start
March 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
August 18, 2016
Record last verified: 2016-08