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Stratified care for patients with sciatica in primary care

Stratified care for patients with sciatica and suspected sciatica in primary care: a randomised trial (the SCOPiC trial - SCiatica Outcomes in Primary Care)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75449581
Enrollment
470
Registered
2014-11-20
Start date
2015-05-04
Completion date
Unknown
Last updated
2020-10-26

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

Conditions

Sciatica Musculoskeletal Diseases Sciatica

Interventions

1. Usual non-stratified care. Participants randomised to this arm will receive usual, non-stratified care. They will be seen by a physiotherapist for one off assessment and treatment including educati

Sponsors

Keele University (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and over 2. Consulting in general practice with back and/or leg symptoms, and GP suspects sciatica 3. Following clinical assessment in research clinics, have a clinical diagnosis of sciatica 4. Have a mobile phone that can receive and send SMS texts or have access to a land-line telephone 5. Able to read and communicate in English (to give full informed consent and to complete the baseline and outcome assessments) 6. Willing to participate

Exclusion criteria

Exclusion criteria: 1. Have suspected serious spinal pathology or ?red-flags? (eg. cauda equina syndrome, suspicion of spinal tumours, infection, fractures, inflammatory spondyloarthopathy) 2. Have had any previous lumbar spine surgery 3. Are currently receiving ongoing care from or have been in consultation with a secondary care doctor or physiotherapist for the same problem in the last 3 months 4. Have serious co-morbidity preventing them from attending the research clinic and/or been able to undergo assessment and potentially interventions 5. Have severe enduring mental health condition 6. Are currently pregnant 7. Are currently participating in any other research study because they have symptoms of back and leg pain or sciatica

Design outcomes

Primary

MeasureTime frame
Time to resolution of sciatica symptoms measured on a 6-point ordered categorical scale. Data will be collected by weekly SMS text messages for the first 4 months, then from months 4 to 12 the SMS data collection will change to monthly, or until patients report on two consecutive occasions that they have recovered.

Secondary

MeasureTime frame
1. Leg and back usual pain severity is measured using pain intensity of back and leg pain at baseline, 4 and 12 months 2. Disability is measured using Roland Morris Disability Questionnaire at baseline, 4 and 12 months 3. Overall impact of sciatica symptoms is measured using Sciatica Bothersomeness Index at baseline, 4 and 12 months 4. Sleep disturbance is measured using Jenkins sleep questionnaire at baseline, 4 and 12 months 5. Fear of movement is measured using Tampa Scale of Kinesiophobia at baseline, 4 and 12 months 6. Anxiety and depression is measured using Hospital Anxiety and Depression Scale at baseline, 4 and 12 months 7. Risk of poor outcome is measured using STarT Back Tool at baseline, 4 and 12 months 8. Quality of life is measured using EQ5D-5L at baseline, 4 and 12 months 9. General health is measured using SF-1 at baseline, 4 and 12 months 10. Neuropathic pain scales is measured using S-LANSS at baseline, 4 and 12 months 11. Days lost from work and productivity loss due to sciatica is measured using Questions on employment status and work absence (days) at 0, 4 & 12 months 12. Pain medication is measured using Patient Questionnaires at baseline, 4 and 12 months 13. Adverse events are measured using clinicians and Patient Questionnaires at baseline, 4 and 12 months 14. Patient satisfaction with care is measured using 5-point scale at baseline, 4 and 12 months 15. Health economic measures and health utilisation is measured using EQ-5D-5L at baseline, 4 and 12 months

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 6, 2026