Traumatic Rotator Cuff TearSPeEDyNCT04027205
Surgery Versus PhysiothErapist-leD Exercise for Traumatic Tears of the Rotator Cuff
A study testing Physiotherapist-led exercise and Surgical repair in people with Traumatic Rotator Cuff Tear, run by Keele University at 1 site in United Kingdom.
Trial summary
The SPeEDy study is a parallel group, pilot and feasibility randomised controlled trial (RCT) with integrated Quintet Recruitment Intervention (QRI) and further qualitative interviews. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Rotator Cuff Tear
- What is being tested?
- Physiotherapist-led exercise and Surgical repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2020to 3 Feb 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years)
- Diagnosed with a symptomatic tear of the rotator cuff following a traumatic incident thought to be of sufficient force to induce a tear.
- Rotator cuff tear confirmed by diagnostic ultrasound or MRI scan undertaken as part of routine diagnostic work-up
- Eligible for rotator cuff repair surgery or a programme of physiotherapist-led exercise as determined by the attending clinician (surgeon or physiotherapist, where appropriate)
- Able to return to the participating NHS hospital or associated orthopaedic and physiotherapy services (where physiotherapists have been trained in trial interventions) for post-operative rehabilitation or the programme of physiotherapist-led exercise.
- Able to understand English.
Who cannot join
- Not eligible for rotator cuff repair surgery or a programme of physiotherapist-led exercise as determined by the attending clinician (surgeon or physiotherapist, where appropriate)
- Patients who are unable to give full informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgery Versus PhysiothErapist-leD Exercise for Traumatic Tears of the Rotator Cuff: a Multi-site Pilot and Feasibility Randomised Controlled Trial (the SPeEDy Study)
The SPeEDy study is a parallel group, pilot and feasibility randomised controlled trial (RCT) with integrated Quintet Recruitment Intervention (QRI) and further qualitative interviews. The study hypothesis is: In adult patients diagnosed with traumatic tears of the rotator cuff, is it feasible to conduct a future, substantive, multi-site RCT to test the hypothesis that physiotherapist-led exercise is not inferior to surgical repair of the rotator cuff in terms of clinical outcomes but is more cost-effective.
Read the detailed description
Tears of the rotator cuff are a significant cause of shoulder pain. Rates of surgical repair have risen approximately 200% over the last 20 years across Europe and the USA. 9 189 repairs were undertaken in 2015/ 2016 in the NHS. The cost of surgery ranges from £2 897 to £5 593 meaning that direct NHS treatment costs alone are £26.6 to £51.4 million annually.
If a patient is suspected of having a traumatic rotator cuff tear, then guidance from the British Elbow and Shoulder Society and British Orthopaedic Association suggests this is a 'red flag' needing urgent surgical opinion. But, this guidance is open to question. Three randomised controlled trials (RCT) (n = 252) have been synthesised in a systematic review which concluded that surgery is not more effective than conservative care for rotator cuff tears. But, of the 252 patients included, only 40 (16%), were diagnosed with traumatic tears. Hence, there is a dearth of randomised evidence to inform decision-making.
Given uncertainty about the comparative effectiveness of surgery and considering the cost, risk, for example infection, there is an urgent need to carry out high-quality research in this area.
Research Question: In patients diagnosed with traumatic tears of the rotator cuff, is it feasible to conduct a future multicentre RCT to test the hypothesis that physiotherapist-led exercise is not inferior to surgical repair in terms of clinical outcomes but is more cost-effective.
Research Design: Two-arm, parallel group, pilot and feasibility RCT with nested Quintet Recruitment Intervention (QRI) and qualitative interviews.
Setting: Eight NHS hospitals.
Objectives:
- Determine feasibility of recruiting and retaining patients,
- Identify barriers and facilitators to recruitment and retention, including patient and clinician equipoise and proportion and reasons for treatment cross-over (reflective of known challenges in surgical RCTs),
- Estimate the number of potential and willing sites for the future main trial.
Participants: Adults with traumatic tears of the rotator cuff, eligible for surgery.
Intervention/ control: Participants will be allocated on a 1:1 ratio, stratified by tear size to: 1) Structured and progressive physiotherapist-led exercise; 2) Surgical repair and usual post-operative rehabilitation.
Key feasibility outcomes: 1) Numbers of patients screened, eligible, approached, consenting, randomised, and accepting allocation; 2) Rate of retention and follow-up; 3) Feasibility of recruiting participating sites; 4) Participant satisfaction.
Key clinical outcomes: 1) Shoulder pain and function (Oxford Shoulder Score): Quality of life (EQ-5D-5L) at baseline, three, and six months.
Health economic outcomes: Health care resource use and days lost from work over six-months.
Sample size: 76 participants.
Analysis: Analysis will focus on process outcomes (recruitment, retention, and treatment cross-over). Means and confidence intervals of clinical outcomes will be calculated only to inform the sample size calculation for the future main trial.
The QRI will use targeted methods including interviews with clinicians and patients, audio-recording of recruitment appointments and document review to understand and then develop an action plan to optimise recruitment and informed consent. Semi-structured qualitative interviews will explore treatment acceptability and the data will be analysed thematically.
- Conditions
- Traumatic Rotator Cuff Tear
- Being tested
- Physiotherapist-led exercise, Surgical repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapist-led exerciseOther
A programme of physiotherapist-led exercise over approximately 12 weeks.
Surgical repairProcedure or surgery
Surgical repair of the rotator cuff plus usual post-operative rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapist-led exercise | Experimental | Structured and progressive physiotherapist-led exercise programme. Reflective of current guidance for exercise programmes for people with rotator cuff disorders, an individualised programme developed in relation to the participant's specific goals will be prescribed by the physiotherapist and supported over approximately six contact sessions across a 12-week period. Receives: Other: Physiotherapist-led exercise |
| Surgical repair | Active comparator | Surgical repair of the rotator cuff plus usual post-operative rehabilitation. Receives: Procedure: Surgical repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of patients screened, number eligible, number approached, number consenting, number randomised, and number accepting allocation
Numbers of patients screened, number eligible, number approached, number consenting, number randomised, and number accepting allocation will be recorded descriptively
Measured: Over recruitment period, 15 months
Numbers of participants continuing in allocated treatment
Numbers of participants continuing in allocated treatment will be recorded descriptively
Measured: Six months
Follow-up response rates to questionnaires (including Oxford Shoulder Score and EQ-5D-5L)
Follow-up response rates to questionnaires will be recorded descriptively
Measured: Three months post-randomisation
Follow-up response rates to questionnaires (including Oxford Shoulder Score and EQ-5D-5L)
Follow-up response rates to questionnaires will be recorded descriptively
Measured: Six months post-randomisation
Determination of zone of clinical equipoise
Data from screening logs, including reasons for not approaching potentially eligible patients will be recorded descriptively to inform determination of zone of clinical equipoise
Measured: Over recruitment period, 15 months
Treatment cross-over
Numbers of participants receiving treatment (surgery or PT-led exercise) other than that which was allocated to determine proportion of participants who cross-over will be recorded descriptively
Measured: Six months
Participant satisfaction with the interventions: five-point ordinal scale
Participant satisfaction with the interventions on a five-point ordinal scale; Very Satisfied/Satisfied/Neutral/Dissatisfied/Very Dissatisfied
Measured: Six months
Secondary outcomes (4)
Pain and disability assessed using the Oxford Shoulder Score (OSS)
The OSS is a 12-item shoulder-specific self-report measure of shoulder pain and function primarily for the assessment of outcome of shoulder surgery in RCTs. The OSS is reliable, valid, responsive and acceptable to patients. The items refer to the past 4 weeks with five ordinal response options scored from 0 to 4, with 4 representing the best outcome. When the 12 items are summed, this produces an overall score ranging from 0 to 48, with 48 being the best outcome.
Measured: Three and six months post-randomisation
Health related quality of life assessed using the EQ-5D-5L
The EQ-5D-5L is a generic measure of health related quality of life that provides a single index value for health status that can be used for the purpose of clinical and health economic evaluation. The EQ-5D-5L consists of questions relating to five health domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and respondents rate their degree of impairment using five response levels (no problems, slight problems, moderate problems, severe problems and extreme problems). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A total of 3125 possible health states can be defined in this way which can then be converted in to a single index value between 0 and 1,
Measured: Three and six months post-randomisation
Days lost from work due to the shoulder problem
Days lost from work due to the shoulder problem will be recorded descriptively on a self-report questionnaire
Measured: Three and six months post-randomisation
Time taken to return to driving
Time taken to return to driving will be recorded descriptively on a self-report questionnaire
Measured: Three and six months post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start3 Mar 2020
- Primary completion3 Feb 2021
- Study completion3 Feb 2021
Why it stopped: Due to Covid-19 disruption
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Rotator Cuff TearStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keele University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University Hospitals of Derby and Burton NHS Foundation Trust, University Hospitals, Leicester, Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust, University Hospitals of North Midlands NHS Trust, University Hospitals Coventry and Warwickshire NHS Trust, Airedale NHS Foundation Trust, Liverpool University Hospitals NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Chris Littlewood, PhD, Principal investigator, Manchester Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027205
- Sponsor's protocol ID
- RG-0292-19-IPCHS
- Acronym
- SPeEDy
- Status last verified
- Feb 2021
- First submitted
- 16 Jul 2019
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymised datasets generated during and/or analysed during the current study are/will be available upon request from primarycare.datasharing@keele.ac.uk. Core data will be available immediately after publication of the trial results. A data request form is required to be completed and must outline the type of data to be obtained, the reason for obtaining this data (research question / objective), the timing for when the data is required to be available (start date/end date). Checks will be performed by a Data Custodian and Academic Proposals (DCAP) committee at Keele to ensure that the data set requested is appropriately suited to answer the research question/objective and that the request fits with the original ethical approval and participant consent and adheres to funder and legal restrictions. Only de-identified data are available for request in aggregated format or at the level of the individual participant.
Publications
Littlewood C, Wade J, Butler-Walley S, Lewis M, Beard D, Rangan A, Bhabra G, Kalogrianitis S, Kelly C, Mehta S, Singh HP, Smith M, Tambe A, Tyler J, Foster NE. Protocol for a multi-site pilot and feasibility randomised controlled trial: Surgery versus PhysiothErapist-leD exercise for traumatic tears of the rotator cuff (the SPeEDy study). Pilot Feasibility Stud. 2021 Jan 7;7(1):17. doi: 10.1186/s40814-020-00714-x.
PubMed 33413664Littlewood C, Astbury C, Bush H, Gibson J, Lalande S, Miller C, Pitt L, Tunnicliffe H, Winstanley R. Development of a physiotherapist-led exercise programme for traumatic tears of the rotator cuff for the SPeEDy study. Physiotherapy. 2021 Jun;111:66-73. doi: 10.1016/j.physio.2020.07.008. Epub 2020 Aug 3.
PubMed 33316867
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Versus PhysiothErapist-leD Exercise for Traumatic Tears of the Rotator Cuff: a Multi-site Pilot and Feasibility Randomised Controlled Trial (the SPeEDy Study)
- ClinicalTrials.gov ID
- NCT04027205
- Acronym / sponsor ID
- SPeEDy / RG-0292-19-IPCHS
- Conditions
- Traumatic Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to Covid-19 disruption
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Keele UniversityUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University Hospitals of Derby and Burton NHS Foundation Trust, University Hospitals, Leicester, Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust, University Hospitals of North Midlands NHS Trust, University Hospitals Coventry and Warwickshire NHS Trust, Airedale NHS Foundation Trust, Liverpool University Hospitals NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 19 Jul 2019 (actual)
- 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.
The SPeEDy study is a parallel group, pilot and feasibility randomised controlled trial (RCT) with integrated Quintet Recruitment Intervention (QRI) and further qualitative interviews. The study hypothesis is: In adult patients diagnosed with traumatic tears of the rotator cuff, is it feasible to conduct a future, substantive, multi-site RCT to test the hypothesis that physiotherapist-led exercise is not inferior to surgical repair of the rotator cuff in terms of clinical outcomes but is more cost-effective.
Detailed description
Tears of the rotator cuff are a significant cause of shoulder pain. Rates of surgical repair have risen approximately 200% over the last 20 years across Europe and the USA. 9 189 repairs were undertaken in 2015/ 2016 in the NHS. The cost of surgery ranges from £2 897 to £5 593 meaning that direct NHS treatment costs alone are £26.6 to £51.4 million annually.
If a patient is suspected of having a traumatic rotator cuff tear, then guidance from the British Elbow and Shoulder Society and British Orthopaedic Association suggests this is a 'red flag' needing urgent surgical opinion. But, this guidance is open to question. Three randomised controlled trials (RCT) (n = 252) have been synthesised in a systematic review which concluded that surgery is not more effective than conservative care for rotator cuff tears. But, of the 252 patients included, only 40 (16%), were diagnosed with traumatic tears. Hence, there is a dearth of randomised evidence to inform decision-making.
Given uncertainty about the comparative effectiveness of surgery and considering the cost, risk, for example infection, there is an urgent need to carry out high-quality research in this area.
Research Question: In patients diagnosed with traumatic tears of the rotator cuff, is it feasible to conduct a future multicentre RCT to test the hypothesis that physiotherapist-led exercise is not inferior to surgical repair in terms of clinical outcomes but is more cost-effective.
Research Design: Two-arm, parallel group, pilot and feasibility RCT with nested Quintet Recruitment Intervention (QRI) and qualitative interviews.
Setting: Eight NHS hospitals.
Objectives:
- Determine feasibility of recruiting and retaining patients,
- Identify barriers and facilitators to recruitment and retention, including patient and clinician equipoise and proportion and reasons for treatment cross-over (reflective of known challenges in surgical RCTs),
- Estimate the number of potential and willing sites for the future main trial.
Participants: Adults with traumatic tears of the rotator cuff, eligible for surgery.
Intervention/ control: Participants will be allocated on a 1:1 ratio, stratified by tear size to: 1) Structured and progressive physiotherapist-led exercise; 2) Surgical repair and usual post-operative rehabilitation.
Key feasibility outcomes: 1) Numbers of patients screened, eligible, approached, consenting, randomised, and accepting allocation; 2) Rate of retention and follow-up; 3) Feasibility of recruiting participating sites; 4) Participant satisfaction.
Key clinical outcomes: 1) Shoulder pain and function (Oxford Shoulder Score): Quality of life (EQ-5D-5L) at baseline, three, and six months.
Health economic outcomes: Health care resource use and days lost from work over six-months.
Sample size: 76 participants.
Analysis: Analysis will focus on process outcomes (recruitment, retention, and treatment cross-over). Means and confidence intervals of clinical outcomes will be calculated only to inform the sample size calculation for the future main trial.
The QRI will use targeted methods including interviews with clinicians and patients, audio-recording of recruitment appointments and document review to understand and then develop an action plan to optimise recruitment and informed consent. Semi-structured qualitative interviews will explore treatment acceptability and the data will be analysed thematically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapist-led exercise | Experimental | Other: Physiotherapist-led exerciseStructured and progressive physiotherapist-led exercise programme. Reflective of current guidance for exercise programmes for people with rotator cuff disorders, an individualised programme developed in relation to the participant's specific goals will be prescribed by the physiotherapist and supported over approximately six contact sessions across a 12-week period. |
| Surgical repair | Active comparator | Procedure: Surgical repairSurgical repair of the rotator cuff plus usual post-operative rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (≥18 years)
- Diagnosed with a symptomatic tear of the rotator cuff following a traumatic incident thought to be of sufficient force to induce a tear.
- Rotator cuff tear confirmed by diagnostic ultrasound or MRI scan undertaken as part of routine diagnostic work-up
- Eligible for rotator cuff repair surgery or a programme of physiotherapist-led exercise as determined by the attending clinician (surgeon or physiotherapist, where appropriate)
- Able to return to the participating NHS hospital or associated orthopaedic and physiotherapy services (where physiotherapists have been trained in trial interventions) for post-operative rehabilitation or the programme of physiotherapist-led exercise.
Key exclusion criteria (2 listed)
- Not eligible for rotator cuff repair surgery or a programme of physiotherapist-led exercise as determined by the attending clinician (surgeon or physiotherapist, where appropriate)
- Patients who are unable to give full informed consent.
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 |
|---|---|---|
| Physiotherapist-led exerciseA programme of physiotherapist-led exercise over approximately 12 weeks. | Other | Physiotherapist-led exercise |
| Surgical repairSurgical repair of the rotator cuff plus usual post-operative rehabilitation | Procedure or surgery | Surgical repair |
Primary outcome
Numbers of patients screened, number eligible, number approached, number consenting, number randomised, and number accepting allocation
Time frame: Over recruitment period, 15 months
Numbers of patients screened, number eligible, number approached, number consenting, number randomised, and number accepting allocation will be recorded descriptively
Numbers of participants continuing in allocated treatment
Time frame: Six months
Numbers of participants continuing in allocated treatment will be recorded descriptively
Follow-up response rates to questionnaires (including Oxford Shoulder Score and EQ-5D-5L)
Time frame: Three months post-randomisation
Follow-up response rates to questionnaires will be recorded descriptively
Follow-up response rates to questionnaires (including Oxford Shoulder Score and EQ-5D-5L)
Time frame: Six months post-randomisation
Follow-up response rates to questionnaires will be recorded descriptively
Determination of zone of clinical equipoise
Time frame: Over recruitment period, 15 months
Data from screening logs, including reasons for not approaching potentially eligible patients will be recorded descriptively to inform determination of zone of clinical equipoise
Treatment cross-over
Time frame: Six months
Numbers of participants receiving treatment (surgery or PT-led exercise) other than that which was allocated to determine proportion of participants who cross-over will be recorded descriptively
Participant satisfaction with the interventions: five-point ordinal scale
Time frame: Six months
Participant satisfaction with the interventions on a five-point ordinal scale; Very Satisfied/Satisfied/Neutral/Dissatisfied/Very Dissatisfied
4 secondary outcomes
Pain and disability assessed using the Oxford Shoulder Score (OSS)
Time frame: Three and six months post-randomisation
Health related quality of life assessed using the EQ-5D-5L
Time frame: Three and six months post-randomisation
Days lost from work due to the shoulder problem
Time frame: Three and six months post-randomisation
Time taken to return to driving
Time frame: Three and six months post-randomisation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 33413664Littlewood C, Wade J, Butler-Walley S, Lewis M, Beard D, Rangan A, Bhabra G, Kalogrianitis S, Kelly C, Mehta S, Singh HP, Smith M, Tambe A, Tyler J, Foster NE. Protocol for a multi-site pilot and feasibility randomised controlled trial: Surgery versus PhysiothErapist-leD exercise for traumatic tears of the rotator cuff (the SPeEDy study). Pilot Feasibility Stud. 2021 Jan 7;7(1):17. doi: 10.1186/s40814-020-00714-x.
- Derived from this study: PubMed 33316867Littlewood C, Astbury C, Bush H, Gibson J, Lalande S, Miller C, Pitt L, Tunnicliffe H, Winstanley R. Development of a physiotherapist-led exercise programme for traumatic tears of the rotator cuff for the SPeEDy study. Physiotherapy. 2021 Jun;111:66-73. doi: 10.1016/j.physio.2020.07.008. Epub 2020 Aug 3.
- Individual participant dataSharing planned: Yes. The anonymised datasets generated during and/or analysed during the current study are/will be available upon request from primarycare.datasharing@keele.ac.uk. Core data will be available immediately after publication of the trial results. A data request form is required to be completed and must outline the type of data to be obtained, the reason for obtaining this data (research question / objective), the timing for when the data is required to be available (start date/end date). Checks will be performed by a Data Custodian and Academic Proposals (DCAP) committee at Keele to ensure that the data set requested is appropriately suited to answer the research question/objective and that the request fits with the original ethical approval and participant consent and adheres to funder and legal restrictions. Only de-identified data are available for request in aggregated format or at the level of the individual participant.
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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 Littlewood, PhD principal investigator
Manchester Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapist-led exercise and Surgical repair in people with Traumatic Rotator Cuff Tear, run by Keele University 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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 18 Feb 2021. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Numbers of patients screened, number eligible, number approached, number consenting, number randomised, and number accepting allocation (time frame: Over recruitment period, 15 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04027205, which also lists 2 linked publications.
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 Feb 2021.