SPiRIT. Shoulder pain: randomised trial of injectable treatments
| ISRCTN | ISRCTN12536844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12536844 |
| IRAS number | 294982 |
| Secondary identifying numbers | CPMS 50349, NIHR201473, IRAS 294982 |
- Submission date
- 15/09/2021
- Registration date
- 17/09/2021
- Last edited
- 22/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Shoulder pain accounts for 1–2% of all adult consultations with a GP in the UK. Despite being a common injury, shoulder pain does not always have a favourable outcome with current treatments.
Currently, the most common treatments are steroid injections combined with physiotherapy or keyhole surgery but there are questions about whether using steroid injections is actually safe in the long term.
This has led to the development of new injectable treatments aimed to help tendons repair themselves. These are termed 'biologic' injections.
The aim of this study is to see if it is feasible to compare one of these biologic-injection treatments against steroid injections.
Who can participate?
All adults, 18 years and older who have symptoms suggestive of subacromial pain syndrome and would normally be offered CorticoSteroid injections treatment for their injury.
What does the study involve?
50 participants will be recruited to the trial. Half will receive CorticoSteroid injection treatment and half will receive a 'biologic' injection. All participants will be asked for a sample of blood. This blood will be spun to create the Autologous Protein Solution for the ‘biologic’ injection treatment. Those participants receiving CorticoSteroid injections will have their blood samples discarded, this is to ensure that participants will not know which injection they have received.
What are the possible benefits and risks of participating?
Both treatments are used across the NHS so there is no specific advantage to taking part in the study, however, participation will help us improve treatment for future patients with similar pain.
After receiving either injection, some participants may experience mild to moderate pain local to the injection site. The rare risk of infection following an injection for both treatments is the same.
Where is the study run from?
The University of Oxford is the lead centre for the study, and the day-to-day running of the study is being completed by Oxford Trauma and Emergency Care.
When is the study starting and how long is it expected to run for?
August 2021 to June 2023
Who is funding the study?
National Institute for Health Research (NIHR) – Research for Patient Benefit (RfPB) (UK).
Who is the main contact?
Kylea Draper, spirit@ndorms.ox.ac.uk
Prof. Steve Gwilym, steve.gwilym@ndorms.ox.ac.uk
Contact information
Scientific
Oxford Trauma & Emergency Care (OTEC)
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS)
Kadoorie Centre
Level 3, John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)7554669554 |
|---|---|
| steve.gwilym@ndorms.ox.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 40424 SPIRIT_PIS_V1.0_30Jul2021.pdf |
| Scientific title | SPiRIT (Shoulder Pain: Randomised trial of Injectable Treatments) A randomised feasibility study of autologous protein solution (APS) vs corticosteroids for treating subacromial shoulder pain. |
| Study acronym | SPIRIT |
| Study objectives | The aim of the SPIRIT is to see if it is feasible to compare a autologous protein solution against corticosteroids for treating subacronmial shoulder pain |
| Ethics approval(s) | Approved 23/09/2021, Cambridge Central REC (City Link Nottingham, Equinox House, Nottingham, NG2 4LA, UK; +44 (0)2071048384; cambridgecentral.rec@hra.nhs.uk), ref: 21/EE/0211 |
| Health condition(s) or problem(s) studied | Shoulder pain |
| Intervention | The informed consent process will commence when the usual-care clinician decides the patient is to be referred for therapeutic injection and meets the eligibility criteria for the SPIRIT trial. The clinical team will initially approach the patient about the trial. As per normal standard practice, the patient will be contacted to arrange a date, time and location of their treatment appointment. In this phone call the study team will introduce the trial to the potential participant. If the patient indicates interest in participating they will be booked into a specific SPiRIT intervention clinic and will have a participant information sheet (PIS) sent via email At the 'SPIRIT clinic' appointment a trial clinician will have an informed consent discussion with patient and if happy to proceed the patient will provide written electronic consent using a trial tablet or computer. Once completed, an electronic version of the signed consent form will be automatically emailed to the participant. All Baseline CRFs will then be completed on web-based data collection service. Once informed consent has been given and Baseline CRFs completed, the participant will be randomised by the local research team using a web-based service. Allocations will be implemented immediately after randomisation, participants will be blinded to the injection that they receive. To avoid bias in the delivery of the intervention and completion of patient reported outcomes, the patients are to be kept blind about the treatment that is allocated. This blinding will be achieved by collecting the blood sample required for APS (55 ml, approximately the volume of an egg cup) from both groups of patients. In the intervention group, this blood will be used for the preparation of the APS; in the control group, this blood will be sham-prepared as APS, but discarded. This approach was discussed with the Oxford Trauma PPI group and they collectively agreed that this was an acceptable approach to avoid any placebo-effect. Researchers and clinical team are not blinded to the intervention received. Participants will then receive a weekly text/email/phone call up to week 8 post-randomisation with a link to a visual analogue scale asking them to indicate their level of pain in the previous 24 hours. At 3 and 6 months post-randomisation, participants will be contacted via text/email/phone call and invited to complete the VAS, PROMIS, OSS, EQ-5D-5L, WPAI, resource use and complications questionnaires. If patients do not complete the triggered URL Link they will be contacted by phone by the central trial team within 7 days. Drugs and dosage: Intervention: Autologous Protein Solution (APS). Approximately 55ml of blood will be taken from the participant and will be spun on a centrifuge. This will result in approx. 5mls of APS solution which will be injected into the site of the shoulder pain. This treatment will occur once during the trial, immediately post randomisation. Comparator: Corticosteroids (CSI). Approximately 55ml of blood will be taken from the participant and will be discarded. This is to ensure blinding. The participant will then receive injection containing Depo-medrone (40mg) mixed with 3mls of 0.5% bupivacaine local anaesthetic. This treatment will occur once during the trial, immediately post randomisation. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Depo-medrone, bupivacaine |
| Primary outcome measure | 1. The conversion rate of eligible to randomised participants until the end of the recruitment period measured using screening logs 2. Total number of participants recruited until the end of the recruitment period measured using screening logs |
| Secondary outcome measures | 1. Levels of retention at follow-up dates until the end of follow-up period (will be measured using all patient facing case report forms) 2. Data compliance at follow-up until the end of follow-up period (will be measured using all patient facing case report forms) 3. Completion rates of PROMIS upper limb physical function, PROMIS pain interference questionnaire, Oxford Shoulder Score (OSS), EQ-5D-5L score at baseline, 3 months and 6 months post-randomisation (will be measured using the following questionnaires :PROMIS upper limb physical function, PROMIS pain interference questionnaire, Oxford Shoulder Score (OSS), EQ-5D-5L) 4. Completion rates of Pain visual analogue score (VAS) at baseline, weekly up to 8 weeks, 3 and 6 months post-randomisation (will be measured using the following questionnaires. Pain Visual Analogue score (VAS)) 5. Completion rates of Patient complications up to 6 months post-randomisation (will be measured using patient complication Case report forms) 6. Completion rates of Work Productivity Impairment Questionnaire (WPAI) at baseline, 3 months and 6 months post-randomisation. (will be measured using the following questionnaires. Work Productivity Impairment Questionnaire (WPAI) 7. Patient and hospital reported resource use including referral rates for shoulder surgery at 6 months post-randomisation (will be measured using patient and hospital resource use case report forms) |
| Overall study start date | 01/08/2021 |
| Completion date | 01/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 50; UK Sample Size: 50 |
| Key inclusion criteria | 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. Clinician believes the patient may benefit from corticosteroid treatment |
| Key exclusion criteria | 1. Participants with a history of significant shoulder trauma (fracture or dislocation in last 5 years) 2. Previous shoulder surgery on the affected shoulder 3. Contraindications to APS therapy or CSI 4. A pre-existing neuro-degenerative and/or vascular condition that affects the function of the shoulder. 5. Received CSI/APS injection in 2 months prior to randomisation 6. The participant is unable to follow trial procedures 7. Patient does not have access to email/ smartphone directly or indirectly |
| Date of first enrolment | 12/04/2022 |
| Date of final enrolment | 12/10/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Leeds
LS9 9EF
United Kingdom
Oxford
OX4 1GE
United Kingdom
Sponsor information
University/education
Joint Research Office
1st floor, Boundary Brook House
Churchill Drive
Oxford
OX3 7GB
England
United Kingdom
| ctrg@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. steve.gwilym@ndorms.ox.ac.uk Any datasets provided will be de-identified, therefore consent will not be required from participants. The PIS has already specified this, so participants are aware of this data sharing possibility. Each request will be considered on a case-by-case basis by the CI. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 30/07/2021 | 15/09/2021 | No | Yes |
| Protocol file | version 1.0 | 30/07/2021 | 15/09/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 17/01/2024 | 18/01/2024 | Yes | No | |
| Results article | 01/07/2024 | 22/07/2024 | Yes | No |
Additional files
Editorial Notes
22/07/2024: Publication reference added.
18/01/2024: Publication reference added.
30/01/2023: The overall end date was changed from 31/01/2023 to 01/06/2023.
18/05/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/10/2021 to 12/04/2022.
2. The recruitment end date has been changed from 01/05/2022 to 12/10/2022.
3. The trial acronym has been added.
4. The ethics approval has been added.
5. The trial participating centre “Healthshare” has been added.
15/09/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
