Rotator Cuff Tear ArthropathyPhase 2NCT02512536
Does Botulinum A Toxin Help With Pain From Rotator Cuff Arthropathy?
A Phase 2 study testing Botulinum Toxin Type A in people with Rotator Cuff Tear Arthropathy, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Rotator cuff arthropathy is a cause of shoulder arthritis which is a common condition seen both in primary and secondary care. It is a painful condition, with significant disability. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear Arthropathy
- What is being tested?
- Botulinum Toxin Type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to 22 Nov 2017
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria The only eligibility criterion for participation in this study is that the patient is medically fit for an operation and diagnosed with symptomatic rotator cuff arthropathy. They must be able to give informed consent and have evidence of cuff arthropathy on plain radiographs of the affected shoulder.
Who cannot join
- Exclusion criteria Contra-indications to surgery (defined as severe cardiac impairment, e.g. heart or valve replacement, arrhythmia, previous myocardial infarction; severe respiratory impairment, e.g. chronic obstructive pulmonary disease, asthma that has required hospital admission; any other systemic medical condition that would produce a specific contraindication to a general anaesthetic).
- Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires, such as dementia or intravenous drug abuse Note: If a recruited patient requires a contra-lateral shoulder botox injection during the trial period, this second shoulder cannot be included in the study since the result of this intervention would not be independent from the first intervention.
- Other exclusion criteria include:
- Previous fractures or dislocations of the shoulder. Previous surgery on the affected shoulder. Any neurological or medical condition resulting in spasticity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Ultrasound Guided Botulinum A Injections Relieve Pain in Rotator Cuff Arthropathy?
Rotator cuff arthropathy is a cause of shoulder arthritis which is a common condition seen both in primary and secondary care. It is a painful condition, with significant disability. Specialist shoulder replacements have found acceptance within the trust, nationally and internationally although there are high complication rates. There is however a significant cost difference (fifty fold) between a reverse total shoulder replacement and a botox injection, and to date there have been no randomised control trials, or any registered, comparing the use of a botox injection for pain relief in cuff arthropathy versus no treatment. If there is a significant clinical difference in the pain outcomes between the two, this could result in significant savings to the NHS and the taxpayer as a whole. If high levels of pain relief could be predictably obtained using Botulinum A toxin injections then potentially patients could avoid the need for surgery.
Read the detailed description
Null Hypothesis This is a pilot / feasability study. The null hypothesis is that there is no effect on the pain or oxford shoulder scores reported by patients receiving a targeted botulinum A toxin injection in the presence of cuff arthropathy at 6 weeks, 3 months or 6 months compared with the baseline values.
Objectives The aim of this feasability study is to provide the necessary information for the planning of a future trial. It will test the feasibility of running such a trial and provide estimates of the differences in outcome measures and information on resource data.
All potential participants for this study will be identified by an Orthopaedic Shoulder Consultant in the shoulder clinics run at the Royal Devon and Exeter NHS Trust. The patients will be screened for eligibility by a research associate (SG). The eligibility criteria will be that the patient is medically fit for an operation, and has painful rotator cuff arthropathy, that is deemed suitable for intervention by the consultant surgeon. The patients will be informed verbally and in writing about the trial by the research associate and informed consent will be taken.
The participating patients will be allocated to an USS guided botox injection. All patients will be asked to complete a number of questionnaires prior to the injection: the Oxford Shoulder Score (OSS), a Visual Analogue Score (VAS) and the EQ-5D. The range of movement of the shoulder joint will be documented in the usual fashion.
The injections will all be done by Dr Anaspure (Consultant Radiologist) under USS guidance in a standard manner.
After the injection, patients will be reviewed using the range of movement, OSS, a patient satisfaction score and EQ-5D at 6 weeks, 3 months and 6 months post injection. A record will be kept of any complications associated with the treatment. This data will be collected by the research associate, who is independent of either intervention.
- Conditions
- Rotator Cuff Tear Arthropathy
- Being tested
- Botulinum Toxin Type A
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type ADrug
Also called Dysport
Ultrasound scan guided injection into supraspinatus muscle belly with Botulinum Toxin Type A
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Intervention:
Subjects receiving a single ultrasound scan guided injection of Botulinum Toxin type A into the supraspinatus muscle belly.
Drug: Dysport 300 units im. One single injection over course of study. Receives: Drug: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post injection Oxford Shoulder Scores
PROM
Measured: At 6 weeks, 3 months and 6 months after injection.
Secondary outcomes (1)
Pain score
VAS
Measured: At 6 weeks, 3 months and 6 months after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startJul 2016
- Primary completion22 Nov 2017
- Study completion22 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear ArthropathyStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Smith, Principal investigator, Royal Devon and Exeter NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512536
- Sponsor's protocol ID
- 1510150
- Status last verified
- Feb 2019
- First submitted
- 29 Jul 2015
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Ultrasound Guided Botulinum A Injections Relieve Pain in Rotator Cuff Arthropathy?
- ClinicalTrials.gov ID
- NCT02512536
- Acronym / sponsor ID
- 1510150
- Conditions
- Rotator Cuff Tear Arthropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 22 Nov 2017 (actual)
- Study completion
- 22 Nov 2017 (actual)
- First posted
- 31 Jul 2015 (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.
Rotator cuff arthropathy is a cause of shoulder arthritis which is a common condition seen both in primary and secondary care. It is a painful condition, with significant disability. Specialist shoulder replacements have found acceptance within the trust, nationally and internationally although there are high complication rates. There is however a significant cost difference (fifty fold) between a reverse total shoulder replacement and a botox injection, and to date there have been no randomised control trials, or any registered, comparing the use of a botox injection for pain relief in cuff arthropathy versus no treatment. If there is a significant clinical difference in the pain outcomes between the two, this could result in significant savings to the NHS and the taxpayer as a whole. If high levels of pain relief could be predictably obtained using Botulinum A toxin injections then potentially patients could avoid the need for surgery.
Detailed description
Null Hypothesis This is a pilot / feasability study. The null hypothesis is that there is no effect on the pain or oxford shoulder scores reported by patients receiving a targeted botulinum A toxin injection in the presence of cuff arthropathy at 6 weeks, 3 months or 6 months compared with the baseline values.
Objectives The aim of this feasability study is to provide the necessary information for the planning of a future trial. It will test the feasibility of running such a trial and provide estimates of the differences in outcome measures and information on resource data.
All potential participants for this study will be identified by an Orthopaedic Shoulder Consultant in the shoulder clinics run at the Royal Devon and Exeter NHS Trust. The patients will be screened for eligibility by a research associate (SG). The eligibility criteria will be that the patient is medically fit for an operation, and has painful rotator cuff arthropathy, that is deemed suitable for intervention by the consultant surgeon. The patients will be informed verbally and in writing about the trial by the research associate and informed consent will be taken.
The participating patients will be allocated to an USS guided botox injection. All patients will be asked to complete a number of questionnaires prior to the injection: the Oxford Shoulder Score (OSS), a Visual Analogue Score (VAS) and the EQ-5D. The range of movement of the shoulder joint will be documented in the usual fashion.
The injections will all be done by Dr Anaspure (Consultant Radiologist) under USS guidance in a standard manner.
After the injection, patients will be reviewed using the range of movement, OSS, a patient satisfaction score and EQ-5D at 6 weeks, 3 months and 6 months post injection. A record will be kept of any complications associated with the treatment. This data will be collected by the research associate, who is independent of either intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Botulinum Toxin Type AIntervention: Subjects receiving a single ultrasound scan guided injection of Botulinum Toxin type A into the supraspinatus muscle belly. Drug: Dysport 300 units im. One single injection over course of study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria The only eligibility criterion for participation in this study is that the patient is medically fit for an operation and diagnosed with symptomatic rotator cuff arthropathy. They must be able to give informed consent and have evidence of cuff arthropathy on plain radiographs of the affected shoulder.
Key exclusion criteria (4 listed)
- Exclusion criteria Contra-indications to surgery (defined as severe cardiac impairment, e.g. heart or valve replacement, arrhythmia, previous myocardial infarction; severe respiratory impairment, e.g. chronic obstructive pulmonary disease, asthma that has required hospital admission; any other systemic medical condition that would produce a specific contraindication to a general anaesthetic).
- Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires, such as dementia or intravenous drug abuse Note: If a recruited patient requires a contra-lateral shoulder botox injection during the trial period, this second shoulder cannot be included in the study since the result of this intervention would not be independent from the first intervention.
- Previous fractures or dislocations of the shoulder. Previous surgery on the affected shoulder. Any neurological or medical condition resulting in spasticity
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 |
|---|---|---|
| Botulinum Toxin Type AAlso: DysportUltrasound scan guided injection into supraspinatus muscle belly with Botulinum Toxin Type A | Drug | Experimental |
Primary outcome
Post injection Oxford Shoulder Scores
Time frame: At 6 weeks, 3 months and 6 months after injection.
PROM
1 secondary outcome
Pain score
Time frame: At 6 weeks, 3 months and 6 months after injection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Chris Smith principal investigator
Royal Devon and Exeter NHS Foundation Trust
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 Botulinum Toxin Type A in people with Rotator Cuff Tear Arthropathy, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 25 Feb 2019. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post injection Oxford Shoulder Scores (time frame: At 6 weeks, 3 months and 6 months after injection.). 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 25 Feb 2019.