Evaluation of the introduction of a new regional back pain process of care in the North East of England

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN65093728

Enrollment

1000

Registered

2016-04-06

Start date

2016-03-30

Completion date

Unknown

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back pain Musculoskeletal Diseases

Interventions

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 Tria

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: There are no specific exclusion criteria

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

England, United Kingdom

Contacts

Public ContactShaun Wellburn

s.wellburn@tees.ac.uk01642 738254

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026