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

August 17, 2016 updated by: Nicolas Pujol, Versailles Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Le CHESNAY, France, 78150
        • Recruiting
        • CH Versailles
        • Contact:
          • Pujol Nicolas, MD
        • Contact:
          • Morisset Laure

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botox arm
intramuscular injection of botulinum toxin
Drug: Botox arm

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versailles Hospital

Investigators

  • Principal Investigator: Pujol Nicolas, MD, CH Versailles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P13/09_ Botox

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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