Table 1.

Outcome measures and delivery time points

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

^a1. Baseline - following clinical assessment

^b2. Intervention only, day of injection 45–60 minutes before and after injection

^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)

^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)

^e5. Follow-up – 3, 6 and 12 months post randomisation