Tendinopathy Rotator CuffPhase 2Botox shoulderNCT02867787
Study of the Treatment of Tendinopathy Unruptured of Rotator Cuff by Intramuscular Injection of Botulinum Toxin
A Phase 2 study testing Botox arm in people with Tendinopathy Rotator Cuff, run by Versailles Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tendinopathy Rotator Cuff
- What is being tested?
- Botox arm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed consent
- Active social care
- Compliant patient with protocol
- Patient more than 18 years
- Positive Neer Test
Who cannot join
- Prior study exclusion period
- Protected patient
- Study refusal
- Deficient patient
- Rheumatoid arthritis, osteoarthritis, chondrocalcinosis.
- Microcrystalline arthritis.
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country.
Morisset Laure contact
France1 site, 1 recruiting
- Recruiting
CH Versailles
Le Chesnay, 78150
Pujol Nicolas, MD
Morisset Laure
About this study
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.
- Conditions
- Tendinopathy Rotator Cuff
- Being tested
- Botox arm
- Keywords
- Shoulder Joint, A02.835.583.748
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox armDrug
| Study group | Role | What they receive |
|---|---|---|
| Botox arm | Experimental | intramuscular injection of botulinum toxin Receives: Drug: Botox arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Significant improvement in life quality : functional clinical scores (Constant, ASES, Oxford)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startMar 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendinopathy Rotator CuffStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Pujol, Versailles Hospital
- Investigators
- Pujol Nicolas, MD, Principal investigator, CH Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867787
- Sponsor's protocol ID
- P13/09_ Botox
- Acronym
- Botox shoulder
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Treatment of Tendinopathy Unruptured of Rotator Cuff by Intramuscular Injection of Botulinum Toxin
- ClinicalTrials.gov ID
- NCT02867787
- Acronym / sponsor ID
- Botox shoulder / P13/09_ Botox
- Conditions
- Tendinopathy Rotator Cuff
- Keywords
- Shoulder Joint, A02.835.583.748
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botox arm | Experimental | Drug: Botox armintramuscular injection of botulinum toxin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed consent
- Active social care
- Compliant patient with protocol
- Patient more than 18 years
- Positive Neer Test
Key exclusion criteria (19 listed)
- Prior study exclusion period
- Protected patient
- Study refusal
- Deficient patient
- Rheumatoid arthritis, osteoarthritis, chondrocalcinosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botox arm | Drug | Botox arm |
Primary outcome
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
1 secondary outcome
Significant improvement in life quality : functional clinical scores (Constant, ASES, Oxford)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
Related trials for Tendinopathy Rotator Cuff
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Active, not recruiting
Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
Latissimus Dorsi Strengthening Exercises in Rotator Cuff Tendinopathy
Rotator Cuff Related Shoulder Pain, Rotator Cuff Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morisset Laure contact
Pujol Nicolas, MD principal investigator
CH Versailles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botox arm in people with Tendinopathy Rotator Cuff, run by Versailles Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morisset Laure (lmorisset@ch-versailles.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2016.