Condition category
Signs and Symptoms
Date applied
06/04/2016
Date assigned
26/04/2016
Last edited
26/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Musculoskeletal pain such as back, knee, neck, shoulder, or multisite pain is very common. It is the number one reason why people take time off work and accounts for a fifth of all GP consultations. Most people soon recover, but about a third of patients still report disabling pain one year after consulting their GP. Early identification of this group of patients as well as finding more effective treatments for them is a high priority. Stratified care involves GPs using a short questionnaire to help identify patients who are at risk of having persistent disabling pain and providing recommended matched treatment options. This study aims to establish if stratified care is more clinically and cost effective compared to usual primary care for these common musculoskeletal conditions.

Who can participate?
Patients aged 18 and over with musculoskeletal pain consulting at participating GP practices

What does the study involve?
Participating GP practices are randomly allocated to either provide stratified or usual care for patients with musculoskeletal pain. The study involves completion of questionnaires so that the researchers can monitor patient outcomes and health care usage. Patients are asked to complete a questionnaire shortly after visiting their GP, answer three short questions every month (via text, email or postcard), and complete a final questionnaire 6 months after consulting their GP. With consent a small number of consultations using the stratified care approach are recorded, and patients and GPs are interviewed about the acceptability and outcomes of stratified care.

What are the possible benefits and risks of participating?
Although there is no direct benefit to the participants, we hope that the learning from the study will help people with pain conditions in the future. This is a low-risk study, and the treatments that the patients receive are all routine in current practice. The questions patients are asked are similar to those that a GP or other healthcare professional might ask.

Where is the study run from?
Keele University (UK)

When is the study starting and how long is it expected to run for?
June 2016 to December 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Stephanie Tooth
s.j.tooth@keele.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Stephanie Tooth

ORCID ID

Contact details

Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-under-Lyme
ST5 5BG
United Kingdom
+44 (0)178 273 4835
s.j.tooth@keele.ac.uk

Type

Scientific

Additional contact

Dr Jonathan Hill

ORCID ID

Contact details

Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-under-Lyme
ST5 5BG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Stratified primary care for musculoskeletal pain: the STarT MSK trial (patient-facing name: the TAPS study)

Acronym

TAPS

Study hypothesis

To determine if stratified care involving use of the STarT MSK tool to allocate individuals into low, medium and high risk subgroups, and matching these subgroups to treatment options, results in improved pain outcomes for adults consulting in primary care for musculoskeletal pain with one of the five most common musculoskeletal pain presentations (back, neck, knee, shoulder and multisite pain).

Ethics approval

We plan to submit for UK Health Research Authority approval in April/May 2016 – submission pending

Study design

Multicentre cluster randomised controlled trial with internal pilot (mixed-methods)

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Adult consulters in primary care with back, neck, knee, shoulder or multisite pain

Intervention

Approximately 30 GP practices in the UK will take part in the trial. 8 practices will be recruited to a pilot phase before recruiting the remaining practices to the main trial. Practices will be randomised to either provide stratified or usual care for patients with back, neck, knee, shoulder or multi-site pain. Patients aged 18 and over consulting at participating GP practices will be invited to take part in the TAPS study. The TAPS study involves completion of questionnaires so that the researchers can monitor patient outcomes and health care usage during the trial. Patients will be asked to complete a questionnaire shortly after visiting their GP, answer 3 short questions every month (via text, email or postcard) and complete a final questionnaire 6 months after consulting their GP. Consent will be sought to record a small number of musculoskeletal consultations using the stratified care approach and interviews with consenting patients and GPs will explore contextual factors that may influence the acceptability of, and outcomes from, stratified care.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Pain intensity measured monthly over the study time period (0-6 months)

Secondary outcome measures

At baseline and 6 month follow-up secondary outcomes include:
1. Site-specific physical functional measures:
1.1. The Roland-Morris Disability Questionnaire (RMDQ) for patients with back pain
1.2. The Neck Disability Index (NDI), the Shoulder pain and disability index (SPADI)
1.3. The Knee Injury and Osteoarthritis Outcome Score Physical Function Short-form (KOOS-PS)
1.4. Physical function for patients with multi-site pain using the Short Form 12v2 Physical Component Scale
2. Other individual patient outcomes of interest include:
2.1. Patients’ musculoskeletal risk status using the STarT MSK Tool
2.2. Symptom severity and impact from the musculoskeletal pain problem measured using the 14-item Musculoskeletal Health Questionnaire, which includes measures of pain interference with sleep, hobbies/leisure activities, work and daily routine, and quality of life with items for patients’ confidence to manage their pain (self-efficacy), mood, and understanding of how to deal with their condition
2.3. Fear avoidance behaviours will be measured using the 11-item Tampa Scale of Kinesiophobia
2.4. Patient perceived level of reassurance from their GP will be captured using the Holt and Pincus et al reassurance scale, which has four sub-scales: information gathering, relationship building, generic reassurance and cognitive reassurance
2.5. A further quality of life scale EQ-5D-5L will be used to calculate quality adjusted life years (QALYs) used in the health economic evaluation
There will be single item questions to capture patient satisfaction with care received, whether they received written education material from their GP, physical activity level, and overall rating of change since their index GP visit.
3. To help describe the population recruited, additional baseline descriptors will capture:
3.1. health literacy using the Single Item Literacy Screener (SILS)
3.2. episode duration of musculoskeletal pain by asking time since last whole month free from this pain
3.3. Age
3.4. Gender
3.5. Employment
3.6. Socio-economic status
4. GP clinical behaviours that are being compared include the proportion of low, medium and high risk patients that are given:
4.1. Analgesic/opioid prescriptions
4.2. Referrals to other services (e.g. to physiotherapy and secondary care specialists)
4.3. Referrals for investigations (e.g. for radiographs, MRI/CT scans, blood tests)
4.4. Sick certifications (fit notes) issued
4.5. Receive further musculoskeletal related GP consultations
5. Questions on additional healthcare resource use and patient-borne costs including:
5.1. Musculoskeletal pain-related inpatient stays
5.2. Outpatient attendances
5.3. Other NHS and private practice healthcare appointments
5.4. Over-the-counter medicines and treatment
6. Work performance will be assessed through a single-item work presenteeism question, and time (days) off work will be aligned to occupational information to ascertain cost of absenteeism

Overall trial start date

01/06/2016

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years and over
2. Registered with a participating GP practice at the time of the specified study period
3. Read-coded relevant musculoskeletal consultation within the specified study period (termed the “index consultation”; this may be the first, or a repeat consultation)
4. Provided consent for the research team to have information from their GP medical records
5. A completed study template in the GP consultation
6. Consent to monthly follow-up
7. GP confirmation that the index pain is in the back, neck, shoulder, knee or is multi-site pain
8. Completion of the initial postal questionnaire within 4 weeks of their initial mailing date

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3,500

Participant exclusion criteria

1. Indications of serious ‘red flag’ pathology – for example, recent trauma with significant injury; acute, red, hot swollen joint; suspected fracture, joint infection or cancer; inflammatory arthropathy; crystal disease; spondyloarthropathy; polymyalgia rheumatic
2. Urgent care needs (e.g. Cauda Equina Syndrome)
3. Vulnerable patients, including any patients on the ‘Severe and enduring mental health register’ that GPs feel are not stable, or those who have a diagnosis of dementia, or those with a terminal illness, or those who have experienced recent trauma or bereavement
4. Those unable to communicate in English (both in reading and speaking)

Recruitment start date

01/06/2016

Recruitment end date

28/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Keele University
Arthritis Research UK Primary Care Centre Primary Care Sciences Keele University Staffordshire
ST5 5BG
United Kingdom

Sponsor information

Organisation

Arthritis Research UK Primary Care Centre, Keele University

Sponsor details

Research Institute for Primary Care & Health Sciences
Keele University
Staffordshire
Newcastle-under-Lyme
ST5 5BG
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes