Condition category
Musculoskeletal Diseases
Date applied
29/03/2016
Date assigned
06/04/2016
Last edited
07/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Low back pain is a major cause of disability and is one of the most costly conditions in the UK. Patient knowledge of the condition is poor which causes unrealistic expectations and demands on the NHS. These demands are met by a variation in back pain management which often results in expensive investigations and unsuccessful care leading to poor results and patients being unsatisfied. A new process (pathway) of managing back pain is being introduced in the north east of England. The main reason for this new pathway is to introduce a structured way of managing low back pain to reduce the current variation in the way low back pain patients are dealt with.

Who can participate?
Patients presenting with back pain in the north east of England.

What does the study involve?
Each participant is first assessed by their GP (or other first contact) using a back pain questionnaire. This determines whether they are sent to see a specialist Triage and Treat Practitioner (TTP) who then manage their treatment. The TTP decides on the next step of the treatment pathway the patient should attend. This may involve, for example, being referred to therapies such as exercises or acupuncture, attending an Intensive Combined Physical and Psychological Programme (a programme that includes intensive exercise, education and help with long-term self-management of the patients back pain), pain management services and possible surgical options. Data is collected through the use of a variety of clinically validated questionnaires and interviews with both patients and staff.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
The pathway will be introduced in four Clinical Commissioning Group regional areas, South Tees, Darlington, Hartlepool and Stockton on Tees, and Newcastle/Gateshead.

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

Who is funding the study?
The Health Foundation (UK)

Who is the main contact?
Mr Shaun Wellburn
s.wellburn@tees.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mr Shaun Wellburn

ORCID ID

Contact details

Teesside University
Middlesbrough
TS1 3BA
United Kingdom
01642 738254
s.wellburn@tees.ac.uk

Type

Scientific

Additional contact

Mr Shaun Wellburn

ORCID ID

Contact details

Teesside University
Middlesbrough
TS1 3BA
United Kingdom
01642 738254
s.wellburn@tees.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Implementation of the North East regional back pain pathway: an evaluation protocol

Acronym

Study hypothesis

The key evaluation question is; following the implementation of an integrated pathway of care for people with low back pain and acute radiculopathy, what changes are seen in patient outcomes and experiences, and in the performance of the health service? This overarching question can be broken down into six evaluation objectives:

1. To measure and explain changes in the following clinical and social outcomes for patients:
1.1. Pain
1.2. Function
1.3. Employment status
1.4. Quality of life
1.5. Overall improvement
2. To measure and explain changes in the following health service performance indicators:
2.1. Frequency and nature of patient contacts with health professionals
2.2. Frequency and nature of medical investigations (e.g. X-Rays, MRI)
2.3. Waiting times
2.4. Referral patterns
3. To examine the cost effectiveness of the pathway.
4. To gain an understanding of patient experiences and perceptions of the implementation.
5. To gain an understanding of clinicians’ and strategic leaders’ experiences and perceptions of the implementation
6. To assess the sustainability and the scalability of the back pain pathway

Ethics approval

Teesside University Ethics Committee, 18/09/2015, ref. 115/15 and R179/15

Study design

Mixed methods multi-centre interventional evaluation

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Back pain

Intervention

A new clinical pathway of care which operationalises NICE guidelines. Key aspects of the pathway are the use of the STarT Back tool to guide pathway route, and case management of patients through Triage and Treat practitioners (specialist allied health professionals and nurses).

Individuals attending the GP practice or first contact provider (e.g. physiotherapist) will complete a STarT Back questionnaire. The score of the STarT Back will determine whether the patient is discharged, with advice, to self-management or follows the new back pain pathway. Once referred into the pathway the patient will attend with the Triage and Treat Practitioner (TTP). Triage and Manage Practitioner will then refer, as appropriate, to one of the following options:

1. Core therapies (manual therapy, exercises, acupuncture)
2. Intensive Combined Physical and Psychological Programme (CPPP)
3. Pain services
4. Specialist spinal surgical opinion

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

1. Health status, assessed with the EuroQol (EQ5D) questionnaire, at base
2. Pain, assessed using a Pain Numerical Rating Scale
3. Disability caused by back pain, assessed using the Oswestry Disability Index

A qualitative analysis will also be conducted utilising Normalisation Process Theory. Data is collected at baseline, and then again after 5 months and 12 months.

Secondary outcome measures

1. Anxiety, assessed using the General Anxiety Disorder Assessment (GAD7)
2. Patients impression of change in condition, assesed using the Global Subjective Outcome Scale (GSOS)
3. Quality of service, assessed using the Friends and Family Test (FFT)
4. Depression, assessed using The Patient Health Questionnaire (PHQ9)
5. Self-management
6. Work status
7. Work loss
8. Health-care usage
9. Cost-effectiveness analysis

Data is collected at baseline, and then again after 5 months and 12 months.

Overall trial start date

30/03/2016

Overall trial end date

31/01/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients: Individuals who have presented with low back pain in the North East of England
2. Non-patients: Individuals who are involved in the implementation and delivery of the Regional Back Pain Pathway

Participant type

Mixed

Age group

All

Gender

Both

Target number of participants

For the qualitative aspect approximately 60 participants. For the quantitative component it is difficult to project the total throughput of patients during the time frame of the evaluation. However, it is anticipated that this will be greater than 1000 participants.

Participant exclusion criteria

There are no specific exclusion criteria

Recruitment start date

30/03/2016

Recruitment end date

01/06/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hartlepool and Stockton on Tees Clinical Commissioning Group
Billingham Health Centre Queensway
Billingham
TS23 2LA
United Kingdom

Trial participating centre

Darlington Clinical Commissioning Group
Dr Piper House King Street
Darlington
DL3 6JL
United Kingdom

Trial participating centre

Newcastle Gateshead Clinical Commissioning Group
Goldcrest Way Newburn Riverside (Business Park)
Newcastle Upon Tyne
NE15 8NY
United Kingdom

Trial participating centre

South Tees Clinical Commissioning Group
14 Trinity Mews
Middlesbrough
TS3 6AL
United Kingdom

Sponsor information

Organisation

Teesside University

Sponsor details

Borough Road
Middlesbrough
TS1 3BA
United Kingdom
01642 738254
s.wellburn@tees.ac.uk

Sponsor type

University/education

Website

www.tees.ac.uk

Funders

Funder type

Charity

Funder name

The Health Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. To publish one paper on the quantitative findings within six months of completion of the evaluation.
2. To publish two papers on the qualitative findings within six months of completion of the evaluation.

Intention to publish date

31/07/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

07/04/2016: Internal review