title: Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial.
abstract: OBJECTIVE
  To evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome); and efficient working of trial components.
  
  
  METHODS
  A feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012) was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres.
  
  
  METHODS
  Consecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy.
  
  
  METHODS
  Participants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone.
  
  
  METHODS
  Blinded assessments were made at 4 weeks post surgery (baseline) and 12 weeks post baseline (proposed primary end point). Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation.
  
  
  RESULTS
  At discharge, 110 (44%) eligible patients gave consent to be contacted. 59 (54%) patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD) RMDQ was 10.07 (5.58) leaflet and 10.52 (5.94) physiotherapy/leaflet at baseline; and 5.37 (4.91) leaflet and 5.53 (4.49) physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD) change -4.53 (6.41), 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59), 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI) between change from baseline to twelve weeks was 1.65(-2.46 to 5.75). Mean difference (95%CI) between groups at 12 weeks was -0.16 (-3.36 to 3.04). Participant adherence with treatment was good. No adverse events were reported.
  
  
  CONCLUSIONS
  Both interventions were acceptable, and it is promising that they both demonstrated a trend in reducing disability in this population. A randomised controlled trial, using a different trial design, is needed to ascertain the effectiveness of combining the interventions into a stepped care intervention and comparing to a no intervention arm. Findings will guide design changes for an adequately powered randomised controlled trial, using RMDQ as the primary outcome.
  
  
  BACKGROUND
  ISRCTN registry 33808269.
authors.affiliation: School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Alison
authors.initials: A
authors.lastname: Rushton
authors.affiliation: School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Nicola R
authors.initials: NR
authors.lastname: Heneghan
authors.affiliation: Primary Care Clinical Sciences, School of Health and Population Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Melanie
authors.initials: M
authors.lastname: Calvert
authors.affiliation: Physiotherapy Department, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham, United Kingdom.
authors.forename: Alison
authors.initials: A
authors.lastname: Heap
authors.affiliation: Physiotherapy Department, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham, United Kingdom.
authors.forename: Louise
authors.initials: L
authors.lastname: White
authors.affiliation: Health Professions Department (Physiotherapy), Manchester Metropolitan University, Birley Fields, Manchester, United Kingdom.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Goodwin
mesh_terms: D000328:Adult; D017586:Diskectomy / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000503:physiopathology / Q000601:surgery*; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000706:statistics & numerical data; D010045:Outpatients / Q000706:statistics & numerical data; D010147:Pain Measurement; D026741:Physical Therapy Modalities; D010865:Pilot Projects; D011182:Postoperative Care / Q000379:methods*; D011446:Prospective Studies; D011788:Quality of Life; D062707:Return to Work; D063127:Secondary Health Care / Q000379:methods / Q000706:statistics & numerical data; D011795:Surveys and Questionnaires; D013997:Time Factors; D006113:United Kingdom