Back to resultsStudy of the Treatment of Tendinopathy Unruptured of Rotator Cuff by Intramuscular Injection of Botulinum Toxin (Botox shoulder)
Primary Purpose
Tendinopathy Rotator Cuff
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Botox arm
Sponsored by
About this trial
This is an interventional treatment trial for Tendinopathy Rotator Cuff focused on measuring Shoulder Joint, A02.835.583.748
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
- 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
Sites / Locations
- CH VersaillesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Botox arm
Arm Description
intramuscular injection of botulinum toxin
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Significant improvement in life quality : functional clinical scores (Constant, ASES, Oxford)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02867787
Brief Title
Study of the Treatment of Tendinopathy Unruptured of Rotator Cuff by Intramuscular Injection of Botulinum Toxin
Acronym
Botox shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy Rotator Cuff
Keywords
Shoulder Joint, A02.835.583.748
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botox arm
Arm Type
Experimental
Arm Description
intramuscular injection of botulinum toxin
Intervention Type
Drug
Intervention Name(s)
Botox arm
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Significant improvement in life quality : functional clinical scores (Constant, ASES, Oxford)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morisset Laure
Email
lmorisset@ch-versailles.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pujol Nicolas, MD
Organizational Affiliation
CH Versailles
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Versailles
City
Le CHESNAY
ZIP/Postal Code
78150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pujol Nicolas, MD
First Name & Middle Initial & Last Name & Degree
Morisset Laure
12. IPD Sharing Statement
Learn more about this trial
Study of the Treatment of Tendinopathy Unruptured of Rotator Cuff by Intramuscular Injection of Botulinum Toxin
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