Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial.

OBJECTIVE: To determine the feasibility of a randomized controlled trial investigating the effectiveness of physiotherapy for sleep disturbance in chronic low back pain (CLBP) (≥12wks). DESIGN: Randomized controlled trial with evaluations at baseline, 3 months, and 6 months. SETTING: Outpatient physiotherapy department in an academic teaching hospital. PARTICIPANTS: Participants with CLBP were randomly assigned to a walking program (n=20; mean age ± SD, 46.4±13.8y), supervised exercise class (n=20; mean age ± SD, 41.3±11.9y), or usual physiotherapy (n=20; mean age ± SD, 47.1±14.3y). The 3-month evaluation was completed by 44 participants (73%), and 42 (70%) participants completed the 6-month evaluation. INTERVENTIONS: Participants received a physiotherapy-delivered 8-week walking program, an 8-week group supervised exercise class (1 class/wk), or 1-to-1 usual physiotherapy (advice, manual therapy, and exercise). MAIN OUTCOME MEASURES: Sleep was assessed by the self-reported Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Pittsburgh Sleep Diary, and objective actigraphy. RESULTS: Groups were comparable at baseline. Most (95%, n=57) of the participants had sleep disturbance. The acceptability of actigraphy was excellent at baseline (58 of 60 participants), but dropped at 3 months (26 of 44 participants). There were improvements on the PSQI and ISI in all groups at 3 and 6 months, with predominantly medium effect sizes (Cohen d=0.2-0.5). CONCLUSIONS: The high prevalence of sleep disturbance indicated the feasibility of good recruitment in future trials. The PSQI would be a suitable screening tool and outcome measure alongside an objective nonobtrusive sleep outcome measure. The effectiveness of physiotherapy for sleep disturbance in CLBP warrants investigation in a fully powered randomized controlled trial.

Investigation of sleep disturbance in chronic low back pain: an age- and gender-matched case-control study over a 7-night period.

Sleep disturbance is frequently reported by people with chronic low back pain (>12 weeks; CLBP), but few studies have comprehensively investigated sleep in this population. This study investigated differences in subjectively and objectively measured sleep patterns of people with CLBP, and compared this to age- and gender matched controls. Thirty-two consenting participants (n = 16 with CLBP, n = 16 matched controls), aged 24-65 years (43.8% male) underwent an interview regarding sleep influencing variables, completed the Pittsburgh Sleep Quality Index, Insomnia Severity Index, Pittsburgh Sleep Diary, SF36-v2, Hospital Anxiety and Depression Scale, Oswestry Disability Index, Numerical Pain Rating Scales, and underwent seven consecutive nights of actigraphic measurement in the home environment. Compared to controls, people with CLBP had, on self-report measures, significantly poorer sleep quality [Pittsburgh Sleep Quality Index (range 0-21) mean (SD) 10.9 (4.2)], clinical insomnia [Insomnia Severity Index mean (range 0-28) 13.7 (7.6)], lower sleep efficiency, longer sleep onset latency, more time awake after sleep onset, and more awakenings during sleep (p < 0.05). However, no significant differences between groups were found on objective actigraphy (p > 0.05). The findings provide some evidence to support self-reported sleep assessment as an outcome measure in CLBP research, while further research is needed to determine the validity of objective sleep measurement in this population.

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/DESIGN: 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). DISCUSSION: 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. TRIAL REGISTRATION: Current controlled trial ISRCTN54009836.