GRASP - Getting it right: addressing shoulder pain
| ISRCTN | ISRCTN16539266 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16539266 |
| EudraCT/CTIS number | 2016-002991-28 |
| Secondary identifying numbers | OCTRU0105 |
- Submission date
- 13/07/2016
- Registration date
- 14/07/2016
- Last edited
- 06/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Shoulder pain is very common, with around 1% of adults in the UK consulting their GP about a new shoulder problem each year. Most new cases of shoulder pain are caused by problems with the group of muscles and tendons that surround the shoulder joint (rotator cuff). The rotator cuff can be damaged through irritation and inflammation (swelling), trapping of the tendons and/or muscle tears. The main symptom is pain, both when still and when moving the shoulder. Shoulder pain can seriously affect a person’s ability to work, sleep soundly and perform daily tasks. Common treatments include advice, rest, painkillers, anti-inflammatories, physiotherapy and steroid injections. Currently, it is unclear how best to improve physiotherapy for shoulder pain, as it is not known physiotherapy techniques work best for shoulder pain, how exactly they should be delivered, and whether patients do better if they get a steroid injection before starting an exercise programme. The aim of this study is to find out investigate the effectiveness of a progressive exercise programme supervised over 16 weeks by a physiotherapist compared to a single education/advice session (best practice advice). The study will also test whether getting a corticosteroid injection in the shoulder joint before starting either regime helps to relieve pain, enabling comfortable exercise and improving function.
Who can participate?
Adults who have new (within the last six months) shoulder pain caused by a rotator cuff problem who are not currently being treated with physiotherapy or being considered for surgery.
What does the study involve?
Participants are randomly allocated to one of four groups. Those in the first group take part in a progressive exercise programme, which involves up to six sessions with a physiotherapist over 16 weeks where the exercises become more intense as they go on. Those in the second group receive a single face-to-face session in which they are given education, reassurance and self-management exercise advice, including advice on pain management and how to change their activity so as not to cause more pain (best practice advice session). Those in the third group take part in the progressive exercise programme with the addition of an injection of a steroid and local anaesthetic (numbing injection) once before the programme starts and again afterwards. Those in the fourth group receive the same best practice advice session as group two, but receive a steroid and local anaesthetic injection before and after this session. Participants in all groups are examined and complete a range of questionnaires at the start of the study and then 8 weeks, 6 months and 12 months later in order to see if there have been any changes to their pain levels and shoulder function.
A sample of participants taking part are also asked to take part in a sub-study. This involves being randomly allocated to receive either a standard text message or a personalised text message to remind them to complete their follow up questionnaires from the main study. The response rate to the questionnaires is then recorded.
What are the possible benefits and risks of participating?
For those participating in the trial – all will receive some physiotherapy which aims to restore functional movement and reduce pain – the only difference for participants in the trial is that the amount of physiotherapy given will differ as it is not know the best amount of physiotherapy for people to have with a rotator cuff injury. There are no notable risks involved with participating, as all treatments being tested are routinely offered within the NHS.
Where is the study run from?
Botnar Research Centre
Windmill Road
Headington
Oxford
OX3 7LD
When is the study starting and how long is it expected to run for?
June 2016 to July 2020
Who is funding the study?
NIHR Health Technology Assessment Programme (UK)
Who is the main contact?
1. Professor Sally Hopewell (scientific)
sally.hopewell@ndorms.ox.ac.uk
2. Ms Lucy Cureton (public)
grasp@ndorms.ox.ac.uk
Contact information
Scientific
Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
| Phone | +44 1865 223458 |
|---|---|
| sally.hopewell@ndorms.ox.ac.uk |
Public
Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
| Phone | +44 1865 737432 |
|---|---|
| grasp@ndorms.ox.ac.uk |
Study information
| Study design | GRASP: Multi-centre phase 3 2x2 factorial randomised controlled trial PROMPTS (embedded retention trial): Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Clinical and cost effectiveness of progressive exercise compared to best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: a 2x2 factorial randomised controlled trial |
| Study acronym | GRASP |
| Study hypothesis | GRASP: The aim of this study is to investigate: 1. Whether people with a rotator cuff problem do better after a progressive exercise programme supervised over 16 weeks by a physiotherapist or after one best-practice advice session with a physiotherapist 2. Whether getting a corticosteroid injection in the shoulder joint before starting either regime helps to relieve pain, enabling comfortable exercise and improving function PROMPTS (embedded retention trial): The aim of this study is to test the effectiveness of a low-cost personalised text messaging strategy (PROMPTS) to prompt the return of questionnaires, using a randomised controlled trial embedded within the GRASP trial. |
| Ethics approval(s) | Berkshire B Research Ethics Committee, 20/10/2016, ref: 16/SC/0508 |
| Condition | Rotator cuff problem |
| Intervention | GRASP: Consented participants will be randomised to intervention groups (1:1:1:1) using the centralised computer randomisation service RRAMP (https://rramp.octru.ox.ac.uk) provided by the Oxford Clinical Trials Research Unit (OCTRU). Group 1: Progressive exercise programme: The participants randomised to the progressive exercise programme will receive up to six sessions with a physiotherapist over 16 weeks. This programme consists of 3 phases: Phase 1 – assessment and advice Phase 2 – progressive structured resistance training Phase 3 – patient-specific functional restoration Group 2: Best practice advice session: The participants randomised to the best practice advice session will receive a single face-to-face session with a physiotherapist, lasting up to 60 minutes. After a comprehensive shoulder assessment, the participants will be given education, reassurance and self-management exercise advice, including advice on pain management and activity modification. They will also be given a simple set of self-guided exercises that can be progressed and regressed depending on their capability. Group 3: Progressive exercise programme + Methylprednisolone injection or Triamcinolone acetonide injection Participants receive an injection of 40 mg methylprednisolone (Depo-Medrone) together with local anaesthetic in one injection at the same time, or separately, depending on local treatment protocols at sites OR Participants receive an injection of 20-40 mg triamcinolone acetonide (Kenalog) together with local anaesthetic in one injection at the same time, or separately, depending on local treatment protocols at sites. (The local anaesthetic will either be 1% lidocaine (up to 5 ml) or 0.5% bupivacaine hydrochloride (up to 10 ml), again depending on local treatment protocols.) This injection will be given once before the progressive exercise intervention is delivered, then the progressive exercise intervention is delivered. The participants randomised to the progressive exercise programme will receive up to six sessions with a physiotherapist over 16 weeks. This programme consists of 3 phases: Phase 1 – assessment and advice Phase 2 – progressive structured resistance training Phase 3 – patient-specific functional restoration A second injection can be given after 6 weeks, but will only be administered to those patients who receive good initial benefit from their first injection and who request further pain relief to facilitate their exercises. Group 4: Best practice advice session + Methylprednisolone injection or Triamcinolone acetonide injection Participants receive an injection of 40 mg methylprednisolone (Depo-Medrone) together with local anaesthetic in one injection at the same time, or separately, depending on local treatment protocols at sites OR Participants receive an injection of 20-40 mg triamcinolone acetonide (Kenalog) together with local anaesthetic in one injection at the same time, or separately, depending on local treatment protocols at sites. (The local anaesthetic will either be 1% lidocaine (up to 5 ml) or 0.5% bupivacaine hydrochloride (up to 10 ml), again depending on local treatment protocols.) This injection will be given once before the best practice advice session is delivered, then the best practice advice session is delivered. The participants randomised to the best practice advice session will receive a single face-to-face session with a physiotherapist, lasting up to 60 minutes. After a comprehensive shoulder assessment, the participants will be given education, reassurance and self-management exercise advice, including advice on pain management and activity modification. They will also be given a simple set of self-guided exercises that can be progressed and regressed depending on their capability. A second injection can be given after 6 weeks, but will only be administered to those patients who receive good initial benefit from their first injection and who request further pain relief to facilitate their exercises. All participants in every group will be followed-up at baseline, 8 weeks, 6 months and 12 months after randomisation. PROMPTS (embedded retention trial): Participants will be randomised (1:1) to receive one of two interventions: Control group: A standard text message Intervention group: A personalised text message which includes their name The text message will be sent to trial participants after they have been posted their trial follow-up questionnaire by the trial team, according to the first postal follow-up specified in the GRASP protocol after implementing the text message trial. The text message will be sent at the same time as they are expected to receive their postal follow-up questionnaire (i.e., normally 2-4 days after the questionnaire is sent, depending on whether first or second class postage is used). The message will be sent in addition to routine trial follow-up procedures, specifically a reminder follow up questionnaire followed by a phone call to those who do not respond to the reminder. Each text message will contain the same core information. Recipients will be reminded about the arrival of the questionnaire, about the importance of their responses and to return the questionnaire as soon as possible. For participants in the intervention group, text messages will be customised using their name, according to how they preferred to be addressed. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Methylprednisolone injection Triamcinolone acetonide |
| Primary outcome measure | GRASP: Shoulder pain and function is measured using the Shoulder Pain and Disability Index (SPADI) at baseline, 8 weeks, 6 and 12 months. PROMPTS (embedded retention trial): Questionnaire response rate, defined as the proportion of GRASP follow up questionnaires returned by participants. |
| Secondary outcome measures | Current secondary outcome measures as of 09/07/2018: GRASP: 1. Pain is measured using the Shoulder Pain and Disability Index (SPADI) 5-item subscale at baseline, 8 weeks, 6 and 12 months 2. Function is measured using the Shoulder Pain and Disability Index (SPADI) 8-item subscale at baseline, 8 weeks, 6 and 12 months 3. Health-related quality life is measured using the EQ-5D-5L at baseline, 8 weeks, 6 and 12 months 4. Psychological factors are measured using the Fear Avoidance Belief Questionnaire – physical activity 5-item subscale and Pain Self-efficacy questionnaire (short form) at baseline, 8 weeks, 6 and 12 months 5. Sleep disturbance is measured using the Insomnia Severity Index at baseline, 8 weeks, 6 and 12 months 6. Global impression of treatment is measured using the Patient-rated Likert scale at 8 weeks, 6 and 12 months 7. Return to desired activities is measured using the Patient-reported return to desired activities including work, social life and sport activities at 0, 8 weeks, 6 and 12 months 8. Exercise adherence is measured using the Patient-reported adherence to exercise at 8 weeks, 6 and 12 months 9. Medication usage is measured using the Patient-reported prescribed and over the counter medications, additional steroid injection at 8 weeks, 6 and 12 months 10. Work disability is measured by recording the number of days of sick leave taken at 8 weeks, 6 and 12 months 11. Healthcare use is measured by collecting NHS usage data at 8 weeks, 6 and 12 months 12. Out-of-pocket expenses are measured using patient related recording of out of pocket expenses at 8 weeks, 6 and 12 months PROMPTS (embedded retention trial): 1. Time to response, defined as the number of days which elapse between the GRASP follow up questionnaire being mailed out to participants and the questionnaire recorded as being returned to the GRASP trial team 2. The proportion of participants sent a reminder follow up questionnaire 3. The cost-effectiveness of the text message intervention Previous secondary outcome measures: GRASP: 1. Pain is measured using the Shoulder Pain and Disability Index (SPADI) 5-item subscale at baseline, 8 weeks, 6 and 12 months 2. Function is measured using the Shoulder Pain and Disability Index (SPADI) 8-item subscale at baseline, 8 weeks, 6 and 12 months 3. Health-related quality life is measured using the EQ-5D-5L at baseline, 8 weeks, 6 and 12 months 4. Psychological factors are measured using the Fear Avoidance Belief Questionnaire – physical activity 5-item subscale and Pain Self-efficacy questionnaire (short form) at baseline, 8 weeks, 6 and 12 months 5. Sleep disturbance is measured using the Insomnia Severity Index at baseline, 8 weeks, 6 and 12 months 6. Global impression of treatment is measured using the Patient-rated Likert scale at 8 weeks, 6 and 12 months 7. Return to desired activities is measured using the Patient-reported return to desired activities including work, social life and sport activities at 8 weeks, 6 and 12 months 8. Exercise adherence is measured using the Patient-reported adherence to exercise at 8 weeks, 6 and 12 months 9. Medication usage is measured using the Patient-reported prescribed and over the counter medications, additional steroid injection at 8 weeks, 6 and 12 months 10. Work disability is measured by recording the number of days of sick leave taken at 8 weeks, 6 and 12 months 11. Healthcare use is measured by collecting NHS usage data at 8 weeks, 6 and 12 months 12. Out-of-pocket expenses are measured using patient related recording of out of pocket expenses at 8 weeks, 6 and 12 months PROMPTS (embedded retention trial): 1. Time to response, defined as the number of days which elapse between the GRASP follow up questionnaire being mailed out to participants and the questionnaire recorded as being returned to the GRASP trial team 2. The proportion of participants sent a reminder follow up questionnaire 3. The cost-effectiveness of the text message intervention |
| Overall study start date | 01/06/2016 |
| Overall study end date | 31/08/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 704 |
| Total final enrolment | 708 |
| Participant inclusion criteria | GRASP: 1. Men and women aged 18 years and above 2. New episode of shoulder pain (i.e., within the last 6 months) attributable to a rotator cuff disorder (e.g., cuff tendonitis, impingement syndrome, tendinopathy or rotator cuff tear) using the diagnostic criteria set out in the BESS guidelines 3. Not currently receiving physiotherapy 4. Not being considered for surgery PROMPTS (embedded retention trial): All participants in the PROMPTS study will have consented and be enrolled in the GRASP trial which will act as the host trial. In addition to meeting the inclusion criteria for the GRASP trial, the following inclusion criteria will apply for participants enrolled in the embedded PROMPTS study: 1. Participants will have the use of a mobile telephone, 2. Participants will be willing to provide this mobile telephone number and consent for contact to be made by the GRASP trial team using this number |
| Participant exclusion criteria | 1. Participants with a history of significant shoulder trauma (e.g., dislocation, fracture or full thickness tear requiring surgery) 2. Those with a neurological disease affecting the shoulder 3. Those with other shoulder disorders (e.g., inflammatory arthritis, frozen shoulder, glenohumeral joint or instability) or with red flags consistent with the criteria set out in the BESS guidelines 4. Those who have received corticosteroid injection or physiotherapy for shoulder pain in the last 6 months 5. Those with contra-indications to corticosteroid injection |
| Recruitment start date | 01/02/2017 |
| Recruitment end date | 02/05/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Derby
DE22 3DT
United Kingdom
Blackburn
BB2 3HH
United Kingdom
Gloucester
GL1 3NN
United Kingdom
Holt Street
Birmingham
B7 4BN
United Kingdom
The Merlin Centre
Cressex Business Park
Lancaster Road
High Wycombe
HP12 3QL
United Kingdom
United Kingdom
Bedford
MK42 9DJ
United Kingdom
Birkenhead
CH49 5PE
United Kingdom
Bailey Drive
Gillingham
ME8 0PZ
United Kingdom
Marlborough Street
Bristol
BS1 3NX
United Kingdom
Express Park
Bristol Road
Bridgwater
TA6 4RN
United Kingdom
Doncaster
DN2 5LT
United Kingdom
Barnstaple
EX31 4JB
United Kingdom
Steeton
BD20 6TD
United Kingdom
Warrington
WA5 1QG
United Kingdom
Birmingham
B18 7QH
United Kingdom
Sutton-in-Ashfield
NG17 4JL
United Kingdom
United Kingdom
Winwick
WA2 8WA
United Kingdom
ST16 3AG
United Kingdom
Sponsor information
University/education
Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
England
United Kingdom
| Website | www.admin.ox.ac.uk/researchsupport/ctrg/ |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/08/2021 |
|---|---|
| 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 | Direct access to research data will be granted to authorised representatives of the Sponsor, regulatory authorities or the host institution for monitoring and/or auditing of the study to ensure compliance with regulations. Summary results data will be included on the EudraCT database (https://eudract.ema.europa.eu/) within 12 months of the end of the trial. General release will be 5 years after the end of the trial, to allow the investigators sufficient time to complete and report additional analyses of the dataset. The study consent form includes that the patients have consented for anonymised information to be used to support other research. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | statistical analysis plan | 07/09/2020 | 09/09/2020 | No | No |
| Results article | 12/07/2021 | 16/07/2021 | Yes | No | |
| Funder report results | 01/08/2021 | 13/08/2021 | No | No | |
| Other publications | Intervention development | 09/07/2019 | 10/10/2022 | Yes | No |
| Protocol article | 17/07/2017 | 10/10/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Study within a trial | 28/07/2021 | 06/08/2024 | Yes | No |
Editorial Notes
06/08/2024: Publication reference added.
10/10/2022: Publication references added.
13/08/2021: Publication reference added.
16/07/2021: Publication reference added.
09/09/2020: Publication reference added.
14/06/2019: The intention to publish date was changed from 31/08/2020 to 31/08/2021.
09/05/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2019 to 02/05/2019.
2. The total final enrolment number was added.
08/04/2019: The following changes were made:
1. The recruitment end date was changed from 31/03/2019 to 30/04/2019.
2. The overall trial end date was changed from 31/07/2020 to 31/08/2020.
3. The intention to publish date was changed from 31/07/2021 to 31/08/2020.
14/02/2019: IPD sharing statement added.
12/02/2019: The following changes have been made:
1. The recruitment end date was changed from 31/01/2019 to 31/03/2019.
2. The overall trial end date was changed from 31/05/2020 to 31/07/2020.
3. The intention to publish date was changed from 31/05/2021 to 31/07/2021.
11/07/2018: The following changes have been made:
1. The addresses for the following trial participating centres have been added: Derby Teaching Hospitals NHS Foundation Trust, East Lancashire Hospitals NHS Trust, Gloucestershire Hospitals NHS Foundation Trust, Birmingham Community Healthcare NHS Foundation Trust, Buckinghamshire MusIC Service, East Cheshire NHS Trust, Bedford Hospital NHS Trust, Wirral University Teaching Hospital NHS Foundation Trust, Medway Community Healthcare, Bristol Community Health, Somerset Partnership NHS Foundation Trust, Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust, Northern Devon Healthcare NHS Trust and Airedale NHS Foundation Trust.
2. The following were added as trial participating centres: Sandwell & West Birmingham Hospitals NHS Trust, Sherwood Forest Hospitals NHS Foundation Trust, Kent Community Health NHS Foundation Trust, North West Boroughs Healthcare NHS Foundation Trust, Midlands Partnership NHS Foundation Trust.
3. Staffordshire & Stoke on Trent Partnership NHS Trust was removed as a trial participating centre.
10/07/2018: The following changes have been made:
1. Nuffield Orthopaedic Centre was removed as a trial participating centre.
2. Derby Teaching Hospitals NHS Foundation Trust, East Lancashire Hospitals NHS Trust, Gloucestershire Hospitals NHS Foundation Trust, Birmingham Community Healthcare NHS Foundation Trust, Buckinghamshire MusIC Service, East Cheshire NHS Trust, Bedford Hospital NHS Trust, Wirral University Teaching Hospital NHS Foundation Trust, Medway Community Healthcare, Bristol Community Health, Somerset Partnership NHS Foundation Trust, Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust, Northern Devon Healthcare NHS Trust, Airedale NHS Foundation Trust, Staffordshire & Stoke on Trent Partnership NHS Trust and Warrington & Halton Hospitals NHS Foundation Trust were added as trial participating centres.
3. The plain English summary has been changed.
09/07/2018: The secondary outcome measures have been changed
05/06/2017: The recruitment dates have been updated from 01/01/2017 - 31/12/2018 to 01/02/2017 - 31/01/2019
20/03/2017: The trial record has undergone a significant update to incorporate an embedded retention trial (PROMPTS). This has involved adding information to the hypothesis, study design, interventions, outcome measures, inclusion criteria, and plain English summary.
17/10/2016: The public contact has been changed to Lucy Cureton from Vicki Barber.
