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Table 5 Feasibility of the pilot randomised controlled trial for determining the effects of a SMT programme

From: Effects of a movement control and tactile acuity training in patients with nonspecific chronic low back pain and control impairment – a randomised controlled pilot study

Study design
Recruitment rate 34 study participants / 227 interested persons [15.0%]
34 study participants / 37 eligible persons [91.9%]
Recruitment period 29 weeks
Randomisation No significant baseline differences between SMT and GE group in terms of the primary outcomes (Table 5)
Blinding 1 study participant inadvertently revealed group assignment to the assessor [2.9%]
Dropout rate 6 dropouts/ 34 study participants [17.7%]
Assessments
 Safety 1 participant reported an immediate but temporary increase in pain, likely related to a movement control test [2.9%]
 Duration 50–70 min for each assessment (t1a, t1b, t2)
 Acceptance 0 absolute; 0 declined investigation or questionnaires among 34 study participants [0%]
 Completeness and interpretability 1 study participant (2.9%) was unable to undergo an assessment (one test in the movement control test battery); ≥15% of the study participants achieved the highest or lowest value on the scale
BPI: t1a n = 0, t1b n = 0, t2 n = 1 (lowest value)
RMDQ: t1a n = 0, t1b n = 2 (lowest value), t2 n = 4 (lowest value)
ODI: t1a n = 0, t1b n = 1 (highest value), t2 n = 0
SF-36: t1a n = 0, t1b n = 0, t2 n = 0
HADS: t1a n = 0, t1b n = 1 (lowest value), t2 n = 3 (lowest value)
FABQ: t1a n = 0, t1b n = 0, t2 n = 0
n missing values / n Items [%]
BPI: n = 8 missing values / n = 15 Items × 34 = 510 (1.6%)RMDQ: n = 0 missing values / n = 24 Items × 34 = 816 (0%)
ODI: n = 0 missing values / n = 10 Items × 34 = 340 (0%)
SF-36: n = 0 missing values / n = 36 Items × 34 = 1224 (0%)
FABQ: n = 0 missing values / n = 16 Items × 34 = 544 (0%)
HADS: n = 1 missing values / n = 14 Items × 34 = 476 (0.2%)
Interventions
 Treatment dose SMT group: Average frequency of 1.5 sessions per week (total intervention period of 4 weeks)
GE group: Average frequency of 2 sessions per week (total intervention period of 3 weeks)
Median duration of one session: 40 min (both SMT and GE group)
 Feasibility of the exercises in the treatment groups SMT group: n = 1 refused exercise / n = 6 offered exercises (16.7%) related to movement control in one session for 1 study participant
GE group: n = 1 refused exercise / n = 8 offered exercises (12.5%) in one session for 3 study participants
 Acceptance of the interventions All participants in the SMT group exhibited and mentioned high acceptance for all the exercises.
High acceptance was recorded for most exercises in the GE group. Side support was mentioned as being too difficult by some participants, and it introduced difficulties in the grading of the other exercises
 Adverse events n = 1 likely triggered by the GE program (moderate); n = 1 likely not triggered by the SMT program (minor)
Costs (including employer’s contribution)
 Staff
  Training: investigation of the outcomes Total duration: 240 min; cost for two physical therapists: [€160]
  Training: execution of the intervention Intervention group – total duration: 420 min; cost for two physical therapists [€280]
Control group – total duration: 420 min; cost for two physical therapists [€280]
  Screening and examination of the in- and exclusion criteria Telephone Screening: 10–20 min for each patient (n = 227); physical examination: 45–90 min for each patient (n = 55)
Total duration [3405 + 4400 = 7805 min]; cost for one B.Sc. Physical Therapist [€3250]
  Investigation of the outcomes Duration of approximately 60 min for each measurement time point and three time points for each participant (n = 34) resulting in a total duration of 6120 min; cost for a M.Sc. Physical Therapist [€2850]
  Execution of the intervention Each intervention in both groups lasted 30–45 min (average of 38 min), and 6 sessions were conducted for each patient (n = 34) resulting in a total duration of 7752 min; cost for SMT intervention B.Sc. Physical Therapists [€2580]; cost for GE intervention (groups with 2–3 patients) [€825]
  Contacts to the study staff initiated by the participants (questions and wishes) Total duration: Approximately 240 min; cost for a B.Sc. Physical Therapist [€80]
Structure
  Measurement instruments (material costs, license costs, software for the analysis) SF-36100 questionnaires [€82], HADS 100 questionnaires [€168], SPSS software pro rata [€100], and other material costs [€50]
  Equipment for the exercises Therapy Table pro rata [€100]
  Ethics proposal Fee [€300]; cost for a M.Sc. Physical Therapist for a duration of 900 min [€334]
  Registration of the study (DRKS) Total duration: 900 min, cost for a M.Sc. Physical Therapist [€334]
  Recruitment material (Flyer, newspaper advertisement) Flyer [€50]
  1. BPI Brief Pain Inventory, FABQ Fear Avoidance and Beliefs Questionnaire, GE General exercise programme, HADS Hospital Anxiety and Depression Scale, ODI Oswestry Disability Index, RMDQ Roland Morris Disability Questionnaire, SF-36 Short-Form 36, SMT Specific sensorimotor treatment