Process | Completed by | Format of administration | Pre-consent | Baseline | 3-Month follow-up | 12-Month follow-up | Ongoing during treatment period | Reference |
---|---|---|---|---|---|---|---|---|
Identification* | PT | PP | ● | |||||
Screening | RA | Telephone | ● | |||||
Consent | P | PP/DB | ● | |||||
Randomisation | CTU | CTU Database | ● | |||||
Sociodemographics | P | PP/DB | ● | |||||
EuroQol-5D-5L | P | PP/DB | ● | ● | ● | 36 | ||
Medical Outcomes Survey Short Form-12 (V.2) | P | PP/DB | ● | ● | ● | 37 | ||
Roland-Morris Disability Questionnaire | P | PP/DB | ● | ● | ● | 38 | ||
Chronic Pain Acceptance Questionnaire-8 | P | PP/DB | ● | ● | ● | 39 | ||
Committed Action Questionnaire-8 | P | PP/DB | ● | ● | ● | 40 | ||
Numeric Analogue Scale | P | PP/DB | ● | ● | ● | – | ||
Patient-Specific Function Scale | P | PP/DB | ● | ● | ● | 41 | ||
Work and Social Adjustment Scale | P | PP/DB | ● | ● | ● | 42 | ||
Pain Self-Efficacy Questionnaire | P | PP/DB | ● | ● | ● | 43 | ||
Generalised Anxiety Disorder-7 | P | PP/DB | ● | ● | ● | 45 | ||
Life Satisfaction Scale | P | PP/DB | ● | ● | ● | – | ||
Patient Health Questionnaire-9 | P | PP/DB | ● | ● | ● | 46 | ||
Global improvement | P | PP/DB | ● | ● | 47 | |||
Satisfaction with outcome | P | PP/DB | ● | ● | 47 | |||
Treatment credibility | P | PP/DB | ● | ● | 48 | |||
Health-related resource use | P | PP/DB | ● | ● | ● | 49 | ||
Self-reported adverse event | P | PP/DB | ● | ● | – | |||
Clinician-reported adverse event | PT | PP/DB | ● | – | ||||
Treatment attendance | PT | DB | ● | – |
*Includes permission to contact and provision of patient information letter.
CTU, King's Clinical Trials Unit; DB, online database; P, participant; PP, paper and pencil; PT, physiotherapist; RA, research associate.