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Table 2 EASE Back pilot trial outcome measures

From: Evaluating acupuncture and standard care for pregnant women with back pain: the EASE Back pilot randomised controlled trial (ISRCTN49955124)

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])
  1. MDC is minimum data collection where only key outcomes were collected from non-responders