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Table 1 Outcome measures and delivery time points

From: Facet-joint injections for people with persistent non-specific low back pain (FIS): study protocol for a randomised controlled feasibility trial

Type of data Outcome measures Time points
1a 2b 3c 4d 5e
Demographic Age, gender, ethnic group, age at leaving full-time education, occupation, current work status Yes     
History Time since completely free of back pain Yes     
History Previous back pain treatments Yes     
Medications Current medications Yes     Yes
History Satisfaction with health state Yes     Yes
History Troublesomeness question Yes     Yes
Back pain-related disability Roland Morris disability questionnaire [14] Yes     Yes
Back pain-related disability The modified von Korff (MVK) disability score. [15, 16] Yes     Yes
Back pain severity MVK pain scale [15] Yes     Yes
  Modified form of Patient-Generated Index [17, 18] Yes     Yes
Psychological distress Depression, Anxiety, and Positive Outlook Scale (DAPOS). [19] Yes     Yes
Pain self-efficacy Pain self-efficacy questionnaire [20] Yes     Yes
Health-related quality of life SF-12 version 2, reported as physical and mental component scores [21] Yes     Yes
Health utilities EuroQol EQ-5D-5 L [22, 23] Yes   Yes Yes Yes
Well-being Warwick-Edinburgh Mental Well-being Scale (WEMWEBS) [24] Yes     Yes
Pain distribution Troublesomeness grid [10] Yes     
Back pain severity today 11-point pain rating scale [16]   Yes Yes   
Current work status If appropriate date of return to work      Yes
Health and social service resource use Including hospital and community resource, as well as costs to individuals and carers      Yes
  1. a1. Baseline - following clinical assessment
  2. b2. Intervention only, day of injection 45–60 minutes before and after injection
  3. c3. Daily pain score for a period of 35 days starting 7 days before first physiotherapy treatment (via SMS) after which weekly until the endpoint (3 months)
  4. d4. EQ-5D-5 L weekly from first physiotherapy treatment session until night before injection appointment when daily for 8 days; then back to weekly until the endpoint (3 months)
  5. e5. Follow-up – 3, 6 and 12 months post randomisation