Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Danielle van der Windt
01782 734830
d.van.der.windt@keele.ac.uk


Study Location:

Arthritis Research UK Primary Care Centre (lead centre)
Research Institute for Primary Care and Health Sciences Keele University
Keele
ST5 5BG


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PANDA-S: Prognostic AND Diagnostic Assessment of Shoulder pain

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Shoulder pain


Study summary

The problem:
Shoulder problems affect 20% of adults and are often very painful, affecting sleep, work, and everyday life. In England, annually about 1.5 million people visit their GP for shoulder pain, of whom 40% experience on-going pain. Most patients receive treatment from GPs or physiotherapists, but 7 times more patients are having surgery compared with 10 years ago. There is no evidence that surgery provides better results than non-surgical treatments such as shoulder exercises.
Aim:
To develop and test a better approach to assessing the likely cause (diagnosis) and future outcome (prognosis) of shoulder problems, so that treatments are offered to those patients who benefit the most.
This research will benefit patients and the NHS by:
Improving information and advice given to patients about the possible causes of shoulder pain and the best ways to assess and treat shoulder pain.
Research plan:
Recruit 1000 patients consulting their GP or self-referring to physiotherapy with shoulder pain to a follow-up study. Their GPs and physiotherapists will continue to treat them in the way they feel is most appropriate. Willing participants will;
i.Complete 6 questionnaires on pain, difficulties with everyday activities, treatments, and quality of life over 3 years, providing unique information about long-term outcomes
ii.Attend an optional clinical assessment including an ultrasound scan of the shoulder
iii.Complete an optional app or respond to text messages once a week for 12 weeks to provide short term information on shoulder pain and difficulties with everyday activities
iv.Participate in an optional interview about their shoulder pain

Background and study aims
Shoulder problems affect about one in five of adults and are often very painful, affecting sleep, work, and everyday life. In England, about 1.5 million people visit their GP for shoulder pain annually, of whom two in five experience on-going pain. Most patients receive treatment from GPs or physiotherapists, but 7 times more patients are having surgery compared with 10 years ago, but there is no evidence that surgery provides better results than other treatments. This study aims to develop and evaluate a better approach (‘stratified care’) to assessing the likely cause (diagnosis) and future outcome (prognosis) of shoulder problems, so that GPs and physiotherapists can ensure that patients are matched to the treatment most likely to improve their shoulder pain.

Who can participate?
All patients registered at participating general practices or attending self-referral physiotherapy services, aged 18 years or over, presenting with a new episode of shoulder-related pain will be invited to take part. A new episode will be defined as no shoulder-related consultation, no injection, surgery, or physiotherapy-led exercise for shoulder pain, in the last 6 months.

What does the study involve?
We will recruit 1000 patients consulting a GP or self-referral physiotherapy service with shoulder pain, and offer them a comprehensive clinical assessment and ultrasound scan. GPs and physiotherapists will continue to treat their patients in the way they feel is best. We will collect information on pain, disability and quality of life using questionnaires over 3 years. We will also collect information on pain and disability using an app developed in collaboration with our Research Users Group, over 3 months. We will investigate which information from the clinical assessment helps us tell which patients will recover quickly, and which patients develop long-term problems. We will also interview patients and healthcare professionals in order to investigate how they interpret diagnostic and prognostic information, and how they use this information to make decisions regarding further treatment and referral.

What are the possible benefits and risks of participating?
All participants will receive the same treatment that they would have received if they had not participated in the study, so there are no additional risks or benefits to taking part. This research aims to benefit patients and the NHS by:
• Improving information and advice for patients about the possible causes and best ways to assess and treat shoulder pain
• Supporting healthcare professionals to better advise patients which treatment is best for them
• Improving targeting of treatment options, and reducing unnecessary investigations and treatments in those who don’t need them
• Reducing long-term pain, disability, and work loss due to shoulder pain

Where is the study run from?
The study will be run from, and led by, the Arthritis Research UK Primary Care Centre and Keele Clinical Trials Unit based at Keele University with an additional centre run from The Nuffield Centre for Primary Care and Health Sciences at Oxford University.

When is the study starting and how long is it expected to run for? (what is the anticipated start date and the approximate duration of the trial?)
January 2018 to July 2023

Who is funding the study?
The study is funded by the National Institute for Health Research (NIHR) and Arthritis Research UK under grant RP-PG-0615-20002.

If treatment for shoulder pain is targeted earlier and more effectively to those patients who are likely to benefit most, efficiency of care and patient outcomes can be improved.


Observational cohort study

Key dates

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 Feb 2019

31 Mar 2021

Study type

Observational

Intervention Type : Other
Intervention Name :
Intervention Description : Participants will be invited to take part in the cohort study and be followed-up over a period of three years with questionnaires mailed at baseline (shortly after consulting their GP or physiotherapist with shoulder pain) and at 3, 6, 12, 24 and 36 months. After the return of their baseline questionnaire participants will also be invited to the optional aspects of the study. Participants will be mailed an invitation and information leaflet about the research clinic once they have returned their baseline questionnaire and only if they have consented to be in the study. Should participants choose to take part in the research clinic it will take place up to approximately six weeks after the return of the participants’ baseline questionnaire.Participants will be mailed an invitation and information leaflet about the app and SMS text messaging once they have returned their baseline questionnaire and consented to be in the study. Should the participants choose to take part in the app or SMS text messaging data collection they will be asked to complete eleven questions on the app once per week or to complete two questions via SMS text messaging also once a week for a total of twelve weeks. Selected 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 or via the phone. The term participant here refers to those patients who consulted their clinician with shoulder pain and consented to be in the study and also the GPs or physiotherapists whom these patients consulted.


Who can take part?

You can take part if:


1. Registered at participating general practices or attending participating self-referral physiotherapy services2. Aged 18 years or over3. Presenting with a new episode of shoulder-related pain (defined as no shoulder-related consultation, no injection, surgery, or physiotherapy-led exercise for shoulder pain, in the last 6 months)




You may not be able to take part if:

1. Present to the GP or physiotherapist with symptoms or signs indicative of serious pathology (e.g. fractures, infection), have shoulder pain caused by stroke-related subluxation2. Diagnosis of inflammatory arthritis, including rheumatoid arthritis, and polymyalgia rheumatica3. Shoulder pain caused by cervical pathology4. Considered by the GP or physiotherapist to be vulnerable (severe physical and/or mental health problems, dementia)5. Unable to complete written questionnaires in English


Where can I take part?

Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Arthritis Research UK Primary Care Centre (lead centre)
    Research Institute for Primary Care and Health Sciences Keele University
    Keele
    ST5 5BG
  • Primary Care Clinical Trials Unit, Nuffield Department of Primary Health Care Sciences
    University of Oxford Radcliffe Observatory Quarter Woodstock Road
    Oxford
    OX2 6GG

Funders/Sponsors


The study is sponsored by University of Keele and funded by ARTHRITIS RESEARCH UK; Grant Codes: ..,NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0615-20002 .



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for Trial ID: ISRCTN46948079

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