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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