Physiotherapy for sleep disturbance in chronic low back pain: a feasibility randomised controlled trial.
BACKGROUND
Sleep disturbance is becoming increasingly recognised as a clinically important symptom in people with chronic low back pain (CLBP, low back pain >12 weeks), associated with physical inactivity and depression. Current research and international clinical guidelines recommend people with CLBP assume a physically active role in their recovery to prevent chronicity, but the high prevalence of sleep disturbance in this population may be unknowingly limiting their ability to participate in exercise-based rehabilitation programmes and contributing to poor outcomes. There is currently no knowledge concerning the effectiveness of physiotherapy on sleep disturbance in people with chronic low back pain and no evidence of the feasibility of conducting randomized controlled trials that comprehensively evaluate sleep as an outcome measure in this population.


METHODS
This study will evaluate the feasibility of a randomised controlled trial (RCT), exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. A presenting sample of 60 consenting patients will be recruited in the physiotherapy department of Beaumont Hospital, Dublin, Ireland, and randomly allocated to one of the three groups in a concealed manner. The main outcomes will be sleep quality (self-report and objective measurement), and self-reported functional disability, pain, quality of life, fear avoidance, anxiety and depression, physical activity, and patient satisfaction. Outcome will be evaluated at baseline, 3 months and 6 months. Qualitative telephone interviews will be embedded in the research design to obtain feedback from a sample of participants' about their experiences of sleep monitoring, trial participation and interventions, and to inform the design of a fully powered future RCT. Planned analysis will explore trends in the data, effect sizes and clinically important effects (quantitative data), and thematic analysis (qualitative data).


CONCLUSIONS
This study will evaluate the feasibility of a randomised controlled trial exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain.


BACKGROUND
Current controlled trial ISRCTN54009836.
Hurley
Deirdre A
DA
UCD School of Public Health, Physiotherapy & Population Science, University College Dublin, Dublin 4, Ireland. deirdre.hurleyosing@ucd.ie
Eadie
Jennifer
J
O'Donoghue
Grainne
G
Kelly
Clare
C
Lonsdale
Chris
C
Guerin
Suzanne
S
Tully
Mark A
MA
van Mechelen
Willem
W
McDonough
Suzanne M
SM
Boreham
Colin A G
CA
Heneghan
Conor
C
Daly
Leslie
L
D000203:Activities of Daily Living / Q000523:psychology; D002986:Clinical Trials as Topic / Q000379:methods*; D004185:Disability Evaluation; D005081:Exercise Therapy / Q000379:methods / Q000592:standards; D005240:Feasibility Studies; D006801:Humans; D007407:Interviews as Topic; D007494:Ireland; D017116:Low Back Pain / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010809:Physical Fitness / Q000502:physiology; D026741:Physical Therapy Modalities / Q000592:standards*; D011788:Quality of Life / Q000523:psychology; D012107:Research Design; D012647:Self-Assessment; D012893:Sleep Wake Disorders / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D011795:Surveys and Questionnaires; D016138:Walking / Q000502:physiology
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