Acute/subacute sciatica/low back pain Musculoskeletal Diseases
Conditions
Interventions
The FORECAST study is a prospective longitudinal prognostic factor cohort study involving patients with acute/subacute ‘sciatica’ and healthy age- and gender-matched participants without symptoms of s
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. People aged >18 years with a clinical diagnosis of ‘sciatica’ 2. Sciatica symptom onset of the current episode within the past 3 months with a symptom-free period of at least 3 months preceding the current sciatica symptoms 3. A sum score of >4 (on the diagnostic model published by Stynes 2018) will be defined as sciatica (weighted sum score including self-reported sensory changes, below knee pain, leg pain worse than back pain, neurodynamic tests, and neurological deficit) 4. Clinical examination confirms the clinical diagnosis of sciatica and rules out other diagnoses
Exclusion criteria
Exclusion criteria: 1. Presence of other nerve-related disorders (e.g. diabetic neuropathy, stroke) 2. Previous lumbar spine surgery 3. Serious spinal pathologies (e.g. infection, cauda equina syndrome, metastatic lesions) 4. Chronic inflammatory disorders 5. Other pain conditions that may confound assessment (e.g., fibromyalgia) 6. Pregnancy 7. Insufficient command of the English language to obtain consent/complete questionnaires 8. Contraindications to MRI for those selected for scanning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain persistence measured using the below at 3 months and 12 months: 1. The Sciatica Bothersomeness Index20 (SBI) 2. A Numerical Rating Scale (NRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Level of disability in activities of daily living measured using the Oswestry Disability Index at 3 and 12 months 2. Self-perceived change measured using a Global rating of change (GROC) scale at 3 and 12 months 3. Primary prognostic variables (collected at baseline): 3.1. Self-reported sensory profiling measured using the Neuropathic Pain Symptom Inventory (NPSI) and painDETECT questionnaires, and a body chart 3.2. Somatosensory profiling determined with the validated quantitative sensory testing protocol from the German Network for Neuropathic pain, and Conditioned Pain Modulation (CPM) 3.3. Psychosocial profile established through the Patient-Reported Outcomes Measurement Information System (PROMIS for anxiety, depression, fatigue, sleep disturbance, instrumental support, emotional support, ability to participate in social roles and activities), Adverse Childhood Events (ACEs), prolonged hospitalisation for a life-threatening condition (single question with yes/no answer), Pain Catastrophizing Scale (PCS), Ten-Item Personality Index (TIPI), State Optimism Measure (SOM-7), Sciatica Perception Questionnaire (SPQ), Stigma Scale for Chronic Illnesses (SSCI), and International Physical Activity Questionnaires (IPAQ) 3.4. Blood inflammatory markers measured using protein and metabolomic analyses Additional phenotypic data assessed at baseline: 1. Demographic and medical information 2. Clinical examination 3. Self-reported questionnaires: 3.1. Prognostic indicators measured using the STarT Back Screening Tool 3.2. Health-related quality of life measured using the EuroQol EQ-5D questionnaire 3.3. Pain severity measured using a diary 3.4. Micro and macrostructural changes of lumbar nerve roots measured using magnetic resonance neurography in a subset of ~100 patients and ~50 healthy controls | — |
Countries
England, United Kingdom
Contacts
Public ContactAnnina Schmid
Outcome results
None listed