Table 2 EASE Back pilot trial outcome measures
Domains | Description | |||
|---|---|---|---|---|
Process outcomes | Recruitment rates, follow-up rates at 8 weeks (overall and in each treatment arm), attendance at treatment sessions, treatment protocol adherence, key outcome measure completion rates, floor and ceiling effects of key outcomes measures | |||
Maternity record data | ||||
 Maternal outcomes | Gestation week at delivery, live births, length of labour (and second stage of labour), induction required, mode of delivery, episiotomy or a perineal tear, estimated blood loss at birth, antenatal and postnatal haemoglobin count, pain relief during labour | |||
 Neonatal outcomes | Gender, weight, Apgar score at 1 and 5 min, admittance to neonatal unit | |||
Questionnaire data | Timepoint | |||
Baseline | 8 weeks full | 8 weeks MDCa | ||
 Socio-demographics | Age, education (highest qualification), marital status, social support (living alone), number of children and pregnancies, job title, physical demands of work, overall work satisfaction, current body mass index (BMI) and pre-pregnancy BMI | ✓ | ✗ | ✗ |
 Work performance | Work status, time taken off work because of LBP, performance at work | ✓ | ✓ | ✗ |
 Pain location | Body chart (coded into LBP only, LBP with anterior PGP, LBP with pain in other bodily regions, or LBP with anterior PGP and pain in other bodily regions) | ✓ | ✗ | ✗ |
 Pain | Duration of current episode | ✓ | ✗ | ✗ |
Pain index (Dunn et al. 2010 [23]): mean of 3 numerical rating scales (least, usual and current pain) | ✓ | ✓ | ✓ | |
Pain intensity before bed (Elden et al. 2008 [18]) | ✓ | ✓ | ✗ | |
 Sleep | Frequency of pain preventing sleep onset and waking at night | ✓ | ✓ | ✗ |
 Impact of pain on daily activities | Oswestry Disability Index (Fairbank et al. 1980 [24]) and the Pelvic Girdle Questionnaire (Stuge et al. 2011 [25], Grotle et al. 2012 [26]) | ✓ | ✓ | ✓ |
 Quality of life | EuroQol EQ-5D-5L (Herdman et al. 2011 [20]) and SF-12 (Ware et al. 1996 [27]) | ✓ | ✓ | ✗ |
 Use of medication, treatments or appliances | Over the counter and prescribed | ✓ | ✓ | ✗ |
 Treatment specific preferences and expectations | Preference for EASE Back treatments, expectation of effect of EASE Back treatments (11 point NRS no expected change–full recovery) | ✓ | ✗ | ✗ |
 Global improvement | Global rating of change since baseline—1 item 6 response options (complete recovery–much worse) | ✗ | ✓ | ✓ |
 Pregnancy | If still pregnant, if pregnant weeks gestation | ✗ | ✓ | ✓ |
 EASE Back treatment related costs borne by participant | Time off work for appointments (paid, unpaid, self-employed), how work was covered, time impact of treatment on other activities (family/domestic responsibilities, leisure activities, housework, studying), child care costs, accompanied to appointments, mode of transport and transport costs | ✗ | ✓ | ✗ |
 Health care utilisation | Consultations, investigations and treatments | ✗ | ✓ | ✗ |
 Treatment credibility | Confidence treatment helped pain, confidence in recommending treatment to others, perception of logic of treatment, perceived usefulness of treatment for alleviating other complaints | ✗ | ✓ | ✗ |
 Patient satisfaction | Satisfaction with EASE Back treatment package received, satisfaction with results of treatment | ✗ | ✓ | ✗ |
 Perceived side effects of treatment | Any side effects due to treatment and checklist of symptoms | ✗ | ✓ | ✓ |
Objective tests | ||||
 Self-administered objective tests | Participant generated thigh thrust (P4) and bridging test with leg extension (Olsen et al. 2009 [19]) | ✓ | ✗ | ✗ |