Non-specific low back pain Musculoskeletal Diseases Low back pain
Conditions
Interventions
We will identify 100 patients from back pain physiotherapist clinics run at the Walton Centre and Aintree Hospital in Liverpool, UK. We have chosen to recruit 100 individuals based on evidence from pr
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years or older 2. Presence of non-specific LBP without the presence of another condition to explain the pain (ie. cancer, primary musculoskeletal conditions, sciatica) 3. Chronic NsLBP defined as pain persisting for >12 weeks, with pain occurring >4 days/week 4. Non-specific LBP as defined topographically and temporally by the Delphi definition 5. Average weekly pain intensity exceeding 6/10 on VAS scoring 6. LBP that causes severe disability, as defined by the Modified Oswestry Low Back Pain Disability Questionnaire (MODI) 7. Pain may radiate down the buttocks or backs of legs but must not radiate below the knees 8. In patients with features of more widespread, non-specific pain, the low-back pain must be the predominant complaint of pain and the pain intensity of these other pains should not exceed 3/10 on VAS scoring
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding patients 2. Patients with immune deficiency or taking immune modulating drugs 3. Patients with an acute systemic disorder 4. Language other than English as first language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant characteristics, as measured by questionnaire responses and clinical examination findings at baseline: 1. Age and Gender 2. Ethnicity 3. BMI (kg/m²) 4. Past Medical History 5. Past and Current Medications 6. Pain Duration (months) 7. Average Income 8. Highest Educational level achieved 9. Depression severity and risk 10. Markers of life stress exposure 11. Clinical course of pain 12. Tissue swelling in low back pain 13. Alcohol and smoking use 14. Waddell Score 15. Suction blister fluid cytokine levels 16. Anatomical location of most severe pain 17. Presence of widespread, secondary pain 18. Presence and degree of sweating at lower back 19. QST profiles Questionnaires 1. Present Pain Intensity (0-10 scale) 2. Hospital Anxiety and Depression Scale (HADS) 3. Keele STarT back screening tool 4. Brief Pain Inventory 5. Short-Form McGill Pain Questionnaire 6. Coping Strategies Questionnaire 7. Pain Self-Efficacy Questionnaire 8. Daily Stressors Questionnaire 9. EQ-5D 10. painDETECT Questionnaire 11. Revised Illness Perception Questionnaire (IPQ-R) – timeline questions 12. Touch Experiences and Attitudes Questionnaire (TEAQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Somatosensory profiles, as measured by quantitative sensory testing, at baseline 2. Presence of bilateral tissue oedema at the lower back on visual assessment at baseline 3. Presence of excess sweating at the lower back, as measured using the Modified Minors Starch Iodine test at baseline 4. Anatomical site of maximum pain at the lower back, as measured using the painDETECT questionnaire at baseline 5. Local immune mediator levels in non-specific low back pain patients with a CRPS-like presentation, as measured by ELISA analysis at baseline 6. Conversion rate from localised non-specific low back pain to FMS, as measured by the American College of Rheumatology Fibromyalgia criteria, at 12-month follow-up | — |
Countries
United Kingdom
Outcome results
None listed