Physiotherapy post lumbar discectomy : prospective feasibility and pilot randomised controlled trial

Research output: Contribution to journalArticlepeer-review

Authors

  • Alison Heap
  • Louise White
  • Peter C Goodwin

Colleges, School and Institutes

External organisations

  • Physiotherapy Department, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham
  • Manchester Metropolitan University

Abstract

OBJECTIVES: 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.

DESIGN AND SETTING: 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.

PARTICIPANTS: Consecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy.

INTERVENTIONS: Participants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone.

MAIN OUTCOME MEASURES: 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.

TRIAL REGISTRATION: ISRCTN registry 33808269.

Details

Original languageEnglish
Article numbere0142013
JournalPLoS ONE
Volume10
Issue number11
Publication statusPublished - 12 Nov 2015