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Archives of Physical Medicine and Rehabilitation journal homepage: www.archives-pmr.org Archives of Physical Medicine and Rehabilitation 2013;94:2083-92
ORIGINAL ARTICLE
Physiotherapy for Sleep Disturbance in People With Chronic Low Back Pain: Results of a Feasibility Randomized Controlled Trial Jennifer Eadie, MSc,a,b Alexander T. van de Water, MSc,a,c Chris Lonsdale, PhD,a,d Mark A. Tully, PhD,e Willem van Mechelen, PhD,f Colin A. Boreham, PhD,a Leslie Daly, PhD,a Suzanne M. McDonough, PhD,g Deirdre A. Hurley, PhDa From the aInstitute for Sport and Health, UCD School of Public Health, Physiotherapy and Population Science, University College Dublin, Dublin, Ireland; bPhysiotherapy Department, Beaumont Hospital, Dublin, Ireland; cMusculoskeletal Research Centre and School of Allied Health, Department of Physiotherapy, La Trobe University, Bundoora, VIC, Australia; dSchool of Science and Health, University of Western Sydney, Penrith, NSW, Australia; eUKCRC Centre for Excellence for Public Health [Northern Ireland], Queen’s University Belfast, Belfast, Northern Ireland; fEMGOþ Institute for Health and Care Research, Department of Public Health and Occupational Health, VU University Medical Center, Amsterdam, The Netherlands; and gHealth and Rehabilitation Sciences Research Institute, University of Ulster, Newtownabbey, Co. Antrim, UK.
Abstract 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 (nZ20; mean age SD, 46.413.8y), supervised exercise class (nZ20; mean age SD, 41.311.9y), or usual physiotherapy (nZ20; mean age SD, 47.114.3y). 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%, nZ57) 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 dZ0.2e0.5). 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. Archives of Physical Medicine and Rehabilitation 2013;94:2083-92 ª 2013 by the American Congress of Rehabilitation Medicine
Presented to the Society for Back Pain Research, June 10e11, 2010, Odense, Denmark; and the Congress of the European Sleep Research Society, September 14e18, 2010, Lisbon, Portugal. Supported by the Health Research Board Ireland Partnership (grant no. 2007/16). Clinical Trial Registration No.: ISRCTN54009836. No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.
Sleep disturbance has a point prevalence of 50% to 59% in people with chronic low back pain (CLBP) (12wks),1,2 and is associated with reduced sleep duration and quality, increased time to fall asleep, poor daytime function, and greater sleep dissatisfaction and distress.3 People with low back pain (LBP) and sleep disturbance are more likely to attend a hospital for treatment than those
0003-9993/13/$36 - see front matter ª 2013 by the American Congress of Rehabilitation Medicine http://dx.doi.org/10.1016/j.apmr.2013.04.017
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without sleep disturbance.4 Because sleep disturbance has been shown to negatively affect mood, pain, daytime functioning, and general quality of life,3,5 it could negatively impact on the clinical outcomes of health care-seeking people with CLBP. Clinical guidelines for CLBP recommend that sufferers should receive advice on self-management, exercise therapy,6,7 and cognitive behavioral therapy, which have shown positive effects on physical functioning, pain, and mental health in this population. The positive effects of physical activity on sleep disturbance have been reported for healthy sedentary adults8 and people with chronic primary insomnia,9,10 but the effect of exercise and physical activity interventions on sleep disturbance has not been investigated in CLBP. Given the high proportion of people receiving physiotherapy for LBP,11 an investigation of its effects on sleep disturbance is warranted. In order to determine the most effective design for a future randomized controlled trial (RCT), this feasibility study, of which the protocol has been published previously,12 had the following objectives: (1) to pilot the methodologic procedures to determine recruitment rate and actual numbers recruited and determine attrition rates during the intervention and follow-up periods; (2) to determine the prevalence of sleep disturbance in a CLBP sample and evaluate the feasibility of using equipment to measure sleep disturbance within an RCT; (3) to compare changes in sleep quality, pain, function, quality of life, fear avoidance, and patient satisfaction between groups from baseline to follow-up and explore the relation between outcome changes and sleep quality; and (4) to make recommendations to refine the study protocol and determine the sample size for a fully powered RCT.
a computer-generated random allocation sequence prepared centrally by the trial statistician. Because of the nature of the trial, it was not possible to blind participants or treatment providers. All treatments were provided by chartered physiotherapists, and training was provided to incorporate a cognitive behavioral approach for both the WP and the SEC.12 All participants received a copy of The Back Book, which promotes self-management,14 were advised to continue their normal daily activities and medication, and to avoid any other treatment for their LBP during the study period.
Walking program The focus of the 8-week intervention was to increase physical activity through a graded volume-based WP based on the American College of Sports Medicine guidelines15 and previous studies in sedentary populations.16,17 At the initial appointment, shortand long-term goals were agreed, and an educational walking booklet and a Yamax Digiwalker Pedometer Model SW-200a were provided. The starting point of the WP was set (10min, 4d/wk) and aimed to progress to the American College of Sports Medicine recommended levels (30min moderate-intensity physical activity, 5d/wk) by week 515 and to maintain this level for the remainder of the program. All participants were encouraged to use the Borg breathlessness scale to establish their walking intensity at levels 3 (moderate breathlessness) to 4 (somewhat severe),18 previously shown to be reproducible in the general population.19 During the intervention, the treating physiotherapist had weekly contact with participants via telephone to evaluate and progress their program.
Methods Supervised exercise class This was a single-blinded feasibility RCT. Beaumont Hospital Ethics (Medical Research) Committee gave approval for this study. The study protocol has been published12 and was registered in Current Controlled Trials under reference no. ISRCTN54009836. All people aged 18 to 70 years with nonspecific CLBP13 referred for physiotherapy from a medical practitioner who met the eligibility criteria, as outlined in table 1, were invited to participate. Each individual’s eligibility was verified by (1) screening the medical referral letter and available imaging study reports, (2) a screening phone call, and (3) a baseline visit for clinical assessment by the trial coordinator, a specialist neuromusculoskeletal chartered physiotherapist. Willing and eligible individuals were given written and verbal information prior to providing written informed consent. After baseline assessment and objective sleep monitoring for 7 nights at home, consenting participants were randomly allocated to 1 of 3 groups (ie, a walking program [WP], a supervised exercise class [SEC], or usual physiotherapy [UP]). The process used sealed opaque envelopes based on
List of abbreviations: CLBP ISI LBP MCID PSD PSQI RCT SE SEC TST UP WP
chronic low back pain Insomnia Severity Index low back pain minimal clinically important difference Pittsburgh Sleep Diary Pittsburgh Sleep Quality Index randomized controlled trial sleep efficiency supervised exercise class total sleep time usual physiotherapy walking program
The SEC followed a group-based format based on the back to fitness program,20 endorsed by the U.K. National Institute for Health and Clinical Excellence guidelines.7 Participants were required to attend once per week for 8 weeks. The physiotherapist assisted in setting short- and long-term goals and advised participants according to their individual goal and exercise capabilities.
Usual physiotherapy UP was defined as a combination of individualized education/ advice, exercise therapy, and manipulative therapy at the discretion of the treating physiotherapist based on usual practice.21
Baseline assessment At baseline, sociodemographic data (ie, age, sex, work status, medical history, LBP history), blood pressure, body mass index (kg/m2), and cardiorespiratory fitness using the Shuttle Walk Test,22 were recorded. Participants were questioned about sleep-influencing variables, that is, sleeping place (eg, bed, chair), environmental noise (eg, trains, airport, motorway), mattress firmness and age, bed sharing, smoking, alcohol/ caffeine consumption, analgesic/sleeping medication usage,23-30 and the primary reason for their sleep disturbance.
Outcome measures The primary sleep outcomes were the Pittsburgh Sleep Quality Index (PSQI)31 and the Insomnia Severity Index (ISI).32,33 Sleep patterns were recorded using accelerometry (Actiwatch Model www.archives-pmr.org
Physiotherapy for sleep disturbance in low back pain Table 1
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Eligibility criteria
Inclusion Criteria
Exclusion Criteria
People with chronic (3mo) or recurrent (3 episodes in previous 12 months) nonspecific LBP of mechanical origin with/without radiation to the lower limb (ie, pain and discomfort, localized below the costal margin and above the inferior gluteal folds, with or without referred leg pain persisting for at least 12 weeks that is not attributable to a recognizable, known specific pathology (Airaksinen et al13)
Clinically diagnosed primary sleep disorder by an appropriate medical consultant (eg, sleep apnea, primary insomnia, restless leg syndrome) Patients scoring
