Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial

Abstract

ObjectivesTo 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 SettingA 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.ParticipantsConsecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy.InterventionsParticipants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone.Main Outcome MeasuresBlinded 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.ResultsAt 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.ConclusionsBoth 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 RegistrationISRCTN registry 33808269

The effectiveness of exercise program after lumbar discectomy surgery

“…16,19,21 Furthermore, one study used the Roland Morris Disability Questionnaire (RMDQ) for the evaluation. 20 In all four studies there was an improvement in disability. Furthermore, in two of these the reduction of disability was characterized as statistically significant (Table 3) and the…”

“…Two instruments were used to evaluate neck pain, the Visual Analogue Scale (VAS/PVAS). 1,19,20 and the Numeric Pain Rating Scale (NPRS/NRS). 16,21 All five studies found an improvement in pain, but the results were considered statistically significant in three of them (Table 3).…”

Descriptive analysis of a 1:1 physiotherapy outpatient intervention post primary lumbar discectomy: one arm of a small-scale parallel randomised controlled trial across two UK sites

“…A descriptive analysis of the optimised (designed to reflect best practice) 1:1 physiotherapy outpatient intervention embedded within an external pilot and feasibility study in preparation for a randomised controlled trial (RCT) reported elsewhere 16. This was a descriptive analysis of one arm of a small-scale parallel RCT design, randomising consenting patients across two UK sites, the Queen Elizabeth Hospital Birmingham (QEHB) and the Salford Royal Foundation Trust (SRFT), to either the optimised intervention including patient leaflet or patient leaflet alone.…”

“…Demographic data including age, gender, duration of symptoms prior to surgery, planned or emergency surgery, presence of leg and/or back pain, analgesia, employment status and ethnicity were collected to describe participant characteristics. The primary outcome was the Roland Morris Disability Questionnaire (RMDQ), and the choice of secondary measures was informed by patients, surgeons and physiotherapists: Global Perceived Effect (GPE) (1=completely recovered, 2=much improved, 3=slightly improved, 4=not changed, 5=slightly worse, 6=much worse and 7=worse than ever compared with presurgery), Visual Analogue Scale leg pain and back pain (0–10 cm, with 0 ‘no pain’ and 10 ‘worst pain ever’), EQ-5D 5L, time to return to work/normal function/full duty, Tampa Scale for Kinesiophobia (17 items, each rated as 1 ‘strongly disagree’, 2 ‘disagree’, 3 ‘agree’, or, 4 ‘strongly agree’, total score out of 68), Fear Avoidance and Beliefs Questionnaire (FABQ) (16 items rated 0–6 informing two subscales: FABQ physical activity total score 24, and FABQ work 42), Straight Leg Raise, range of lumbar movement, analgesia and reoperation 16. Adherence was measured.…”

“…11 Therefore, prior to planning a trial, an optimised 1:1 physiotherapy outpatient intervention was developed through a rigorous process14 to reflect best practice, with flexibility to tailor management to individual patients in line with Medical Research Council (MRC) guidance regarding the development of complex interventions (see online supplementary file S1). 15 The intervention was evaluated through an external pilot and feasibility study16 that enabled description and analysis of the intervention and physiotherapist decision-making.…”