Can we offer better, more personalised care for people with shoulder pain?
| ISRCTN | ISRCTN45377604 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45377604 |
| IRAS number | 315321 |
| Secondary identifying numbers | CPMS 55765, RP-PG-0615-20002, IRAS 315321 |
- Submission date
- 12/05/2023
- Registration date
- 15/06/2023
- Last edited
- 07/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Shoulder pain is common. In England, 1.5 million people visit their GP with shoulder pain every year. Most people recover quickly, but in 40% the shoulder pain lasts longer than 6 months and affects sleep, work, and everyday life. Patients have highlighted how important the first consultation is with their healthcare professional to discuss their shoulder pain, how it affects their everyday life and how it can be treated. PANDA-S II aims to study how the discussion between patients and physiotherapists during this first appointment can be best supported to ensure appropriate treatment, improvement in shoulder pain and everyday activity.
Who can participate?
Patients with shoulder pain, aged 18 years and over referred / self-referred to participating NHS Physiotherapy services
What does the study involve?
Completing four questionnaires over a 12-month period; a small number of people will be invited to talk to a researcher about their experience of shoulder pain
What are the possible benefits and risks of participating?
The information we get from this study will support physiotherapists to provide the best care for people with shoulder pain. There may not be any immediate benefits for participants, although some people find it rewarding to take part in health research. We are not expecting any risks to people taking part in the PANDA-S II study.
Where is the study run from?
Keele Clinical Trials Unit based at Keele University, Staffordshire (UK)
When is the study starting and how long is it expected to run for?
October 2015 to December 2025
Who is funding the study?
1. National Institute for Health and Care Research (NIHR) (UK)
2. Versus Arthritis (UK)
Who is the main contact?
Keele Clinical Trials Unit, ctu.pandas2study@keele.ac.uk
Contact information
Scientific
Faculty of Medicine and Health Sciences
Keele University
Keele
ST5 5BG
United Kingdom
 ORCID ID |
0000-0002-7248-6703 |
|---|---|
| Phone | +44 1782 733890 |
| d.van.der.windt@keele.ac.uk |
Study information
| Study design | Interventional cluster randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 43650 PIS_v2.0_21Apr2023.pdf |
| Scientific title | Maximising outcome for patients with shoulder pain: using optimal diagnostic and prognostic information to target treatment |
| Study acronym | PANDA-S |
| Study objectives | A more holistic approach to the management of shoulder pain, including an assessment of concerns and healthcare needs, shoulder pain characteristics and prognosis, can inform personalised care and support for self-management, leading to improved patient reported outcomes including shoulder pain and disability. |
| Ethics approval(s) | Approved 28/04/2023, Yorkshire & The Humber - South Yorkshire Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 2071048091; southyorks.rec@hra.nhs.uk), ref: 23/YH/0070 |
| Health condition(s) or problem(s) studied | Shoulder pain |
| Intervention | The design of the trial is a cluster-randomised controlled trial. The physiotherapy services are the unit of randomisation and will be randomised to either deliver the guided consultation of shoulder pain (intervention) or to continue with care as usual (control). All eligible patients, irrespective of whether the site is allocated to the intervention or control arm, will be invited to take part in the trial (shortly after referral or self-referral to the physiotherapy services). Consenting participants will complete a baseline questionnaire and be followed up over a period of 12 months with questionnaires mailed at 6 weeks, 6 and 12 months. Participants will be offered a shopping voucher with each follow-up questionnaire in recognition of the time they are contributing to the trial. After the return of the baseline questionnaire and consent form, participants who come under the care of a Physiotherapy service randomised to the intervention may be invited to the optional aspects of the trial: 1. Audio recording of their physiotherapy consultation: Some participants will be contacted to ask whether they would consent to have their consultation with the physiotherapist audio recorded. Should participants choose to take part in this aspect of the trial, the trial team will confirm the date of their physiotherapy appointment and inform the physiotherapist that the participant has given informed consent. The physiotherapist will reconfirm consent prior to recording. All audio recordings will be securely transferred to Keele CTU and the physiotherapist will wipe the recording from their equipment. 2. Interview: Some participants will be mailed an invitation and information leaflet about the interview once they have returned their baseline questionnaire and consented to be in the study. Should participants choose to take part in the interview an appointment will be made at a time that is convenient to the participant to undertake the interview (face to face, online, or via the phone). In addition to up to 20 study participants, we will also interview up to 10 clinicians (physiotherapists) about their experience of delivering the guided consultation to people with shoulder pain, and how this can be further improved and implemented in their clinical practice. Participants in the intervention arm will receive the guided consultation when they attend their Physiotherapy appointment. Participants in the control arm will receive the usual consultation offered by their Physiotherapy service. |
| Intervention type | Behavioural |
| Primary outcome measure | Shoulder pain and disability are measured using the Shoulder Pain and Disability Index (SPADI) at baseline, 6 weeks, 6 months and 12 months |
| Secondary outcome measures | 1. Perceived change in shoulder pain symptoms will be measured using the Global Perceived Change single-item question at 6 weeks, 6 months, and 12 months 2. Sleep difficulties will be measured using the Jenkins Sleep Questionnaire at baseline, 6 weeks, 6 months and 12 months 3. Work absence will be measured by asking how many days off a participant has had in the past days/weeks at baseline, 6 months and 12 months 4. Work performance will be measured using the single-item work performance VAS scale at baseline, 6 months and 12 months 5. Healthcare utilisation will be measured using standardised items at 6 months and 12 months 6. Health-related quality of life will be measured using the EQ-5D-5L at baseline, 6 weeks, 6 months and 12 months |
| Overall study start date | 02/10/2015 |
| Completion date | 03/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 832; UK Sample Size: 832 |
| Key inclusion criteria | 1. Patients referred or self-referred to participating physiotherapy services 2. Aged 18 years or over 3. Presenting with shoulder pain |
| Key exclusion criteria | 1. Present to the physiotherapy service with symptoms or signs indicative of serious pathology (e.g. fractures, infection, inflammation, malignancy or referred pain from other sites (e.g. cardiac, hepatobiliary)) 2. Have shoulder pain caused by stroke-related subluxation 3. Been referred for rehab post-surgery 4. Have a diagnosis of inflammatory arthritis, including rheumatoid arthritis, and polymyalgia rheumatica 5. Have shoulder pain caused by cervical pathology or predominantly neck pain 6. Are considered by the staff triaging to be vulnerable (e.g. severe physical and/or mental health problems, dementia) |
| Date of first enrolment | 30/06/2023 |
| Date of final enrolment | 03/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
St Georges Hospital
Corporation Street
Stafford
ST16 3SR
United Kingdom
Holt Street
Birmingham Science Park, Aston
Birmingham
B7 4BN
United Kingdom
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Sponsor information
University/education
Keele
Newcastle-under-Lyme
ST5 5BG
England
United Kingdom
| Phone | +44 1782 732890 |
|---|---|
| research.governance@keele.ac.uk | |
| Website | http://www.keele.ac.uk/ |
"ROR" |
https://ror.org/00340yn33 |
Funders
Funder type
Government
No information available
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2026 |
|---|---|
| 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 will be available upon request from medicine.datasharing@keele.ac.uk. Data will become available once the main findings from the trial has been published. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 21/04/2023 | 25/05/2023 | No | Yes |
| HRA research summary | 20/09/2023 | No | No | ||
| Protocol article | 06/05/2025 | 07/05/2025 | Yes | No |
Additional files
Editorial Notes
07/05/2025: Publication reference added.
20/09/2023: A link to the HRA research summary was added.
20/06/2023: Internal review.
12/05/2023: Study's existence confirmed by the NIHR.
