edicine and Rehabilitation

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Archives of Physical Medicine and Rehabilitation 2013;94:2083-92

ORIGINAL ARTICLE

Physiotherapy for Sleep Disturbance in People WithChronic Low Back Pain: Results of a FeasibilityRandomized 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 AlliedHealth, Department of Physiotherapy, La Trobe University, Bundoora, VIC, Australia; dSchool of Science and Health, University of WesternSydney, 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 UniversityMedical 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, 46.4�13.8y), supervised exercise

class (nZ20; mean age � SD, 41.3�11.9y), or usual physiotherapy (nZ20; 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%, 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.

0003-9993/13/$36 - see front matter ª 2013 by the American Congress of Re

http://dx.doi.org/10.1016/j.apmr.2013.04.017

Sleep disturbance has a point prevalence of 50% to 59% in peoplewith chronic low back pain (CLBP) (�12wks),1,2 and is associatedwith reduced sleep duration and quality, increased time to fallasleep, poor daytime function, and greater sleep dissatisfactionand distress.3 People with low back pain (LBP) and sleep distur-bance are more likely to attend a hospital for treatment than those

habilitation Medicine

2084 J. Eadie et al

without sleep disturbance.4 Because sleep disturbance has beenshown to negatively affect mood, pain, daytime functioning, andgeneral quality of life,3,5 it could negatively impact on the clinicaloutcomes of health care-seeking people with CLBP.

Clinical guidelines for CLBP recommend that sufferers shouldreceive advice on self-management, exercise therapy,6,7 and cognitivebehavioral therapy, which have shown positive effects on physicalfunctioning, pain, and mental health in this population. The positiveeffects of physical activity on sleep disturbance have been reportedfor healthy sedentary adults8 and people with chronic primaryinsomnia,9,10 but the effect of exercise and physical activity inter-ventions on sleep disturbance has not been investigated in CLBP.Given the high proportion of people receiving physiotherapy forLBP,11 an investigation of its effects on sleep disturbance iswarranted.

In order to determine the most effective design for a futurerandomized controlled trial (RCT), this feasibility study, of which theprotocol has been published previously,12 had the following objectives:(1) to pilot the methodologic procedures to determine recruitment rateand actual numbers recruited and determine attrition rates during theintervention and follow-up periods; (2) to determine the prevalence ofsleep disturbance in a CLBP sample and evaluate the feasibility ofusing equipment to measure sleep disturbance within an RCT; (3) tocompare changes in sleep quality, pain, function, quality of life, fearavoidance, and patient satisfaction between groups from baseline tofollow-up and explore the relation between outcome changes and sleepquality; and (4) to make recommendations to refine the study protocoland determine the sample size for a fully powered RCT.

Methods

This was a single-blinded feasibility RCT. Beaumont Hospital Ethics(Medical Research) Committee gave approval for this study. Thestudy protocol has been published12 and was registered in CurrentControlled Trials under reference no. ISRCTN54009836. All peopleaged 18 to 70 years with nonspecific CLBP13 referred for physio-therapy from amedical practitionerwhomet the eligibility criteria, asoutlined in table 1, were invited to participate. Each individual’seligibility was verified by (1) screening themedical referral letter andavailable 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. Willingand eligible individuals were given written and verbal informationprior to providing written informed consent. After baseline assess-ment and objective sleep monitoring for 7 nights at home, consentingparticipants were randomly allocated to 1 of 3 groups (ie, a walkingprogram [WP], a supervised exercise class [SEC], or usual physio-therapy [UP]). The process used sealed opaque envelopes based on

List of abbreviations:

CLBP chronic low back pain

ISI Insomnia Severity Index

LBP low back pain

MCID minimal clinically important difference

PSD Pittsburgh Sleep Diary

PSQI Pittsburgh Sleep Quality Index

RCT randomized controlled trial

SE sleep efficiency

SEC supervised exercise class

TST total sleep time

UP usual physiotherapy

WP walking program

a computer-generated random allocation sequence prepared centrallyby the trial statistician. Because of the nature of the trial, it was notpossible to blind participants or treatment providers. All treatmentswere provided by chartered physiotherapists, and training wasprovided to incorporate a cognitive behavioral approach for both theWP and the SEC.12 All participants received a copy of The BackBook, which promotes self-management,14 were advised to continuetheir normal daily activities and medication, and to avoid any othertreatment for their LBP during the study period.

Walking program

The focus of the 8-week intervention was to increase physicalactivity through a graded volume-based WP based on the Amer-ican College of Sports Medicine guidelines15 and previous studiesin sedentary populations.16,17 At the initial appointment, short-and long-term goals were agreed, and an educational walkingbooklet and a Yamax Digiwalker Pedometer Model SW-200a wereprovided. The starting point of the WP was set (�10min, �4d/wk)and aimed to progress to the American College of Sports Medicinerecommended levels (30min moderate-intensity physical activity,5d/wk) by week 515 and to maintain this level for the remainder ofthe program. All participants were encouraged to use the Borgbreathlessness scale to establish their walking intensity at levels 3(moderate breathlessness) to 4 (somewhat severe),18 previouslyshown to be reproducible in the general population.19 During theintervention, the treating physiotherapist had weekly contact withparticipants via telephone to evaluate and progress their program.

Supervised exercise class

The SEC followed a group-based format based on the back to fitnessprogram,20 endorsed by the U.K. National Institute for Health andClinical Excellence guidelines.7 Participants were required toattend once per week for 8 weeks. The physiotherapist assisted insetting short- and long-term goals and advised participantsaccording 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 discre-tion of the treating physiotherapist based on usual practice.21

Baseline assessment

At baseline, sociodemographic data (ie, age, sex, work status,medicalhistory, LBP history), blood pressure, body mass index (kg/m2), andcardiorespiratory fitness using the ShuttleWalk Test,22 were recorded.Participantswere 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 andthe primary reason for their sleep disturbance.

Outcome measures

The primary sleep outcomes were the Pittsburgh Sleep QualityIndex (PSQI)31 and the Insomnia Severity Index (ISI).32,33 Sleeppatterns were recorded using accelerometry (Actiwatch Model

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Table 1 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 <10, indicating minimum

disability on the Oswestry Disability Index

Pregnancy

Unstable angina/uncontrolled cardiac dysrhythmias/severe

aortic stenosis/acute systematic infection accompanied

by fever

Males/females between 18e70y People with any confounding conditions, such as a

neurologic disorder or currently receiving treatment

for cancer

Access to a telephone (for follow-up support) Currently or having received physiotherapy treatment

for CLBP within previous 3mo

No spinal surgery within the previous 12mo Medicolegal issues

People deemed suitable by their general practitioner/hospital

consultant to carry out an exercise program

Red flags indicating serious spinal pathology (eg, cancer,

cauda equina lesion)

People willing to attend an 8-week treatment program of

exercise classes

Radicular pain indicative of nerve root compression

Fluency in English (verbal and written) People diagnosed with severe spinal stenosis,

spondylolisthesis, or fibromyalgia by an appropriate

medical consultant

History of systemic/inflammatory disease

(eg, rheumatoid arthritis)

People with acute (<6wk) or subacute LBP (6e12wk),

provided that they have experienced <3 LBP episodes

during previous 12mo

Physiotherapy for sleep disturbance in low back pain 2085

AW4,)34,b and the Pittsburgh Sleep Diary (PSD).35 The Actiwatchis a piezoelectric accelerometer capable of sensing motion in alldirections. This small wrist watch-like device (37�29�10mm,16g) is worn on the nondominant wrist. Any detected change inmotion is converted to an electric signal and recorded as anactivity count. Participants were requested to wear the Actiwatchfor a 7-night period (starting the first night of recruitment), eitherall day or �30 minutes before they went to bed until �30 minutesafter they awoke. The PSD is a widely used instrument to captureday-to-day information about 8 variables, that is, food and drinktimes and consumption, time and types of medication and exer-cise, time and frequency of naps, time of lights out and finalwakening, number of awakenings, and sleep quality. It wasprovided on the day of recruitment, and participants wererequested to report every item every day concurrent to the 7 nightsof actigraphy. Both measures calculate 5 sleep variables, that is,sleep onset latency (min from lights out/bedtime to sleep onset),total sleep time (TST; min asleep from lights out to final wake up),number of awakenings (bouts of wakening after sleep onset), totalwake time (min awake between sleep onset and final wake up),and sleep efficiency (SE; TST/total time in bed � 100%).

Other outcomes were LBP-related functional disability(Oswestry Disability Index, primary back pain outcome),36 backand leg pain (11-point Numeric Rating Scale),37 quality of life(Medical Outcomes Study 36-Item Short-Form Health Surveyversion 2 physical component and mental component scores),38

fear avoidance beliefs (Fear-Avoidance Beliefs Questionnairephysical activity subscale),39 mood (Hospital Anxiety andDepression Scale),40 and physical activity (International PhysicalActivity Questionnaire),41 and were collected by a blinded assessor

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at baseline, 3 months (face-to-face), and 6 months (postal), apartfrom the PSD and Actiwatch (baseline and 3mo only). Reasons fornoncompliance with the PSD and Actiwatch were recorded bythe trial coordinator. The feasibility of using sleep monitoringequipment was evaluated by an Actiwatch Utility Questionnaireadapted from another questionnaire,42 which was completed afterbaseline actigraphy. A Patient Satisfaction Questionnaire wasadministered at 3-month follow-up. Adverse events were docu-mented in each participant’s physiotherapy chart by type, duration,and frequency, and were reported to the trial coordinator.

Statistical analysis

Statistical analysis based on intention-to-treat was performedusing the Predictive Analytics Software (PASW).c The Actiwatchand PSD data were considered valid if available for �5 nights.43

Raw data from the Actiwatch were screened prior to analysisfor missing values and/or malfunction of the device. The 5 sleepvariables44 were automatically calculated using the Actiwatchsoftware (Sleep V7.27 analysis softwareb), using the mediumsensitivity (40 activity counts per 10s epoch) threshold.45

Because this was a feasibility study, exploratory analyses werecompleted with treatment effects analyzed using means and 95%confidence intervals of the change scores of all outcome measuresfrom baseline at 3 and 6 months, calculation of within-group effectsizes (Cohen d ),46 and the number of participants in each groupachieving a minimal clinically important difference (MCID) on thePSQI (�3)47 and Oswestry Disability Index (�10).48 Participantswho withdrew before follow-up were not included in this analysis.Monthly recruitment rates and the ratio of numbers screened were

Hospital and participant recruitment (n=180) Did not meet inclusion criteria (n=85)

Analysis

Follow-up

Allocation

Enrollment

Excluded (n=21) -Did not meet inclusion criteria (n=11)* -Refused (n=10) -Other reasons (n=0)

Assessed for eligibility in hospital (n=74)

Randomized (n=60)

Excluded (n=14) -Did not meet inclusion criteria (n=10)†-Refused (n=1) -Other reasons (n=3)‡

Allocated to SEC (n=20) Received SEC (n=14) Did not receive SEC (unable to participate, n=2; DNA, n=4)

Allocated to WP (n=20) Received WP (n=16) Did not receive WP (excluded for medical reasons, n=1; refused, n=1; DNA, n=2)

Allocated to UP (n=20) Received UP (n=17) Did not receive UP (withdrawn due to knee pain, n=1; DNA, n=2)

Lost to follow-up (no longer interested): 3mo (n=6) 6mo (n=7) Discontinued (n=0)

Lost to follow-up (no longer interested): 3mo (n= 3) 6mo (n=4) Discontinued (n=0)

Lost to follow-up (no longer interested): 3mo (n=7) 6mo (n=7) Discontinued (n=0)

Analyzed: 3mo (n=14) 6mo (n=13)

Analyzed: 3mo (n=17) 6mo (n=16)

Analyzed: 3mo (n=13) 6mo (n=13)

Assessed for eligibility by phone (n=95)

Fig 1 Consolidated Standards of Reporting Trials flow diagram. Abbreviation: DNA, did not attend for treatment. *Primary sleep disorder: sleep apnea

(nZ3),medicolegal issues (nZ4), uncontrolled cardiac condition (nZ1), and leg pain only (nZ3). yOswestry Disability Index<10 (nZ5), confounding

comorbidities (nZ5): uncontrolled cardiac condition (nZ1), neurologic condition (nZ2), and severe anxiety/depression (nZ2). zDid not attend forbaseline assessment.

2086 J. Eadie et al

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Table 2 Participant sociodemographic and outcome measure variables at baseline

Variable WP (nZ20) SEC (nZ20) UP (nZ20)

Characteristics

Age (y) 46.40�13.8 41.30�11.90 47.10�14.3

Sex, n (male/female) 8:12 8:12 7:13

Duration LBP (mo) 126.30�90.2 93.30�74.60 80.40�104.9

Previous physiotherapy for LBP, n (%) 9.0 (45.0) 10.0 (50.0) 8.0 (40.0)

Medication, n (%)

Pain 16.0 (80.0) 10.0 (50.0) 13.0 (65.0)

Sleep 3.0 (15.0) 2.0 (10.0) 4.0 (20.0)

Antidepressant 5.0 (25.0) 2.0 (10.0) 3.0 (15.0)

Other 12.0 (60.0) 7.0 (35.0) 7.0 (35.0)

Work status, n (%)

Employed 7.0 (35.0) 10.0 (50.0) 12.0 (60.0)

Unemployed 4.0 (20.0) 3.0 (15.0) 1.0 (5.0)

Not in workforce* 9.0 (45.0) 7.0 (35.0) 7.0 (35.0)

Body mass index (kg/cm2) 29.62�6.5 29.31�8.90 28.90�5.6

Blood pressure (mmHg)

Systolic 131.40�15.7 127.60�15.00 129.00�11.9

Diastolic 82.50�9.2 83.30�14.40 79.10�10.5

IPAQ, n (%)

Low 9.0 (45.0) 11.0 (55.0) 11.0 (55.0)

Moderate 7.0 (35.0) 5.0 (25.0) 5.0 (25.0)

High 4.0 (20.0) 4.0 (20.0) 4.0 (20.0)

Readiness to change, n (%)

Precontemplation 1.0 (5.0) 0.0 (0.0) 0.0 (0.0)

Contemplation/preparation 13.0 (65.0) 15.0 (75.0) 11.0 (55.0)

Action/maintenance 6.0 (30.0) 5.0 (25.0) 9.0 (45.0)

SWT completed level (1e12) 6.40 (2.1) 6.6 (1.3) 6.0 (2.4)

Sleep influencing variables

Environmental noise, n (%)

Yes 0.0 (0.0) 0.0 (0.0) 1.0 (5.0)

No 20.0 (0.0) 20.0 (0.0) 19.0 (95.0)

Mattress firmness, n (%)

Soft/medium 2.0 (10.0) 0.0 (0.0) 3.0 (15.0)

Firm 0.0 (0.0) 2.0 (10.0) 3.0 (15.0)

Orthopedic 12.0 (60.0) 11.0 (55.0) 12.0 (60.0)

Other 6.0 (30.0) 7.0 (35.0) 2.0 (10.0)

Mattress age (mo) 56.60�66.8 29.60�19.90 52.90�40.0

Sleeping place, n (%)

Bed 19.0 (95.0) 19.0 (95.0) 19.0 (95.0)

Bed and chair 1.0 (5.0) 1.0 (5.0) 1.0 (5.0)

Bed sharing, n (%)

Yes 10.0 (50.0) 15.0 (75.0) 9.0 (45.0)

No 10.0 (50.0) 5.0 (25.0) 11.0 (55.0)

Smoking within 2h of bedtime, n (%)

Yes 5.0 (25.0) 5.0 (25.0) 5.0 (25.0)

No 15.0 (75.0) 15.0 (75.0) 15.0 (75.0)

Alcohol within 2h of bedtime, n (%)

Yes 5.0 (25.0) 2.0 (10.0) 3.0 (15.0)

No 12.0 (60.0) 14.0 (70.0) 15.0 (75.0)

Weekends only 3.0 (15.0) 4.0 (20.0) 2.0 (10.0)

Caffeine within 2h of bedtime, n (%)

Yes 3.0 (15.0) 7.0 (35.0) 6.0 (30.0)

No 17.0 (85.0) 13.0 (65.0) 14.0 (70.0)

Sleep outcome measures

PSQI (0e21) 11.50�4.3 9.40�4.40 11.20�4.5

ISI (0e28) 15.50�6.4 11.80�7.30 11.30�6.7

Actiwatch nZ16 nZ15 nZ15

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Physiotherapy for sleep disturbance in low back pain 2087

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Table 2 (continued )

Variable WP (nZ20) SEC (nZ20) UP (nZ20)

SOL (min) 14.40�11.9 12.80�18.70 17.30�20.0

TST (min) 413.10�61.5 433.30�52.90 410.70�54.3

NWAK (n) 43.10�17.2 43.30�13.10 35.40�10.9

TWT (min) 64.40�36.5 57.70�20.84 51.20�17.2

SE (%) 83.90�7.1 85.90�5.80 85.40�5.8

PSD nZ12 nZ10 nZ12

SOL (min) 29.90�38.9 18.50�9.90 25.30�17.2

TST (min) 374.20�72.8 405.80�76.20 384.80�66.1

NWAK (n) 2.20�0.9 2.00�1.02 2.20�1.2

TWT (min) 25.10�19.8 19.70�7.20 30.90�23.7

SE (%) 85.50�10.2 91.20�3.70 86.90�9.0

LBP outcome measures

ODI (0e100) 35.70�12.6 32.50�13.90 33.20�15.2

NRS average back pain (0e10) 5.60�2.0 5.28�2.20 6.13�2.1

NRS average leg pain (0e10) 3.30�2.9 2.38�2.80 2.85�2.6

Biopsychosocial outcome measures

HADS (anxiety) (0e21) 11.40�4.5 8.00�4.20 8.60�4.2

HADS (depression) (0e21) 8.80�2.9 5.90�3.10 6.60�4.5

FABQ-PA (0e24) 19.10�3.9 15.40�6.60 15.30�6.4

SF-36 V2 PCS (0e100) 36.70�9.1 37.90�6.30 38.80�7.9

SF-36 V2 MCS (0e100) 36.40�10.3 42.60�12.90 43.40�14.7

NOTE. Data are presented as mean � SD or as otherwise indicated.

Abbreviations: FABQ-PA, Fear-Avoidance Beliefs Questionnaire-physical activity; HADS, Hospital Anxiety and Depression Scale; MCS, mental component

score; NRS, Numeric Rating Scale; NWAK, number of awakenings; ODI, Oswestry Disability Index; PCS, physical component score; SF-36 V2, Medical

Outcomes Study 36-Item Short-Form Health Survey version 2; SOL, sleep onset latency; SWT, Shuttle Walk Test; TWT, total wake time.

* Not in workforce: homemaker, student, retired, long-term disability.

2088 J. Eadie et al

evaluated on completion of recruitment. Rates of adherence andany adverse effects of each intervention were recorded.

Results

Participant flow and retention based on the updated ConsolidatedStandards of Reporting Trials statement49 are displayed infigure 1. Of 180 patients screened, the first 60 (33%) consecutiveparticipants who met the eligibility criteria were recruited. Therecruitment rate was 4.6 participants per month (range, 1e11).Most participants (WP: nZ16 of 20, SEC: nZ14 of 20, UP:nZ17 of 20) received the intervention as allocated. Forty-four(73%) participants completed the 3-month follow-up, and 42(70%) participants completed the 6-month follow-up. Participantscompleted a mean � SD of 6.2�2.1 weeks of the WP (77.5%adherence) compared with 4.0�3.5 weeks of the SEC (50%adherence). UP participants had a mean � SD of 3.5�2.2 visitsover 5.8�3.4 weeks and received individualized education/advice(100%, nZ17), exercise therapy (100%, nZ17), and manipulativetherapy (66.7%, nZ11). Two WP participants reported an increasein LBP (nZ1) or knee pain (nZ1) after 3 weeks, and were treatedwith UP. There were no adverse events in the other groups.

Participants’ baseline characteristics according to group allo-cation are displayed in table 2. Most (95%, nZ57) reportedexperiencing sleep disturbance, and most related it to their LBP(80.7%, nZ46). This was consistent with the baseline PSQIscores, where 93% (nZ56) scored �5 points, indicating disturbedsleep. Rates of insomnia were lower according to the ISI, that is,78% (nZ47) had evidence of insomnia: 36.7% (nZ22)

subthreshold (8e14 points), 31.7% (nZ19) moderate (15e21points), and 10% (nZ6) severe insomnia (22e28 points).

Sleep pattern measures

At baseline, valid Actiwatch data were obtained for 77% (nZ46) ofparticipants, whereas valid PSD data were obtained for 57% (nZ34)of the sample. Missing data for the Actiwatch (23.3%, nZ14) weredocumented as: insufficient nights of recording (ie,�5 nights; 13.3%,nZ8), nonwear (3.3%, nZ2), or malfunction of the device (6.7%,nZ4); and for the PSD (43.3%, nZ26) were because of insufficientnights of recording (23.3%, nZ14) or nonreturn of the diary (20%,nZ12). The PSD found a mean sleep onset latency � SD of25.2�25.9minutes, ameanTST� SDof 386.9�71.4minutes, and anaverage SE � SD of 87.5%�8.5%. The Actiwatch data recordeda mean sleep onset latency� SD of 14.8�25.9 minutes, a TST� SDof 418.91�56.1 minutes, and an average SE � SD of 85.1%�6.2%.

At 3 months, the return of valid data dropped for both theActiwatch (33%, nZ20) and PSD (27%, nZ16). The documentedreasons for missing Actiwatch data (67%, nZ40) were loss tofollow-up (26.7%, nZ16), participant unwillingness (30%, nZ18),insufficient nights of recording (ie, �5 nights; 5%, nZ3), andmalfunction of the device (5%, nZ3); and for the PSD (73%, nZ44)were loss to follow-up (26.7%, nZ16), nonreturn of the diary (35%,nZ21), or insufficient nights of recording (11.7, nZ7).

At baseline, only 20participants (33.3%)had correspondingvalidActiwatch and sleep diary data, and this dropped to 14 participants(23.3%) at 3 months. Because of the high level of noncompliancewith the Actiwatch and the sleep diary, it was considered not valid toanalyze changes between baseline and 3 months.

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Physiotherapy for sleep disturbance in low back pain 2089

The findings of the Actiwatch Utility Questionnaire forparticipants’ satisfaction with the device at baseline were good,that is, the mean acceptability score � SD was 7.9�2.5 and meannoninterference with sleep score � SD was 8.2�3.3 (0Znotacceptable; 10Zvery acceptable). Of the participants that recor-ded their sleep at baseline, 85.4% (nZ35) stated they would bewilling to wear an Actiwatch again within an RCT, and 77.5%(nZ31) felt it was a user-friendly method of measuring sleep.

Treatment effect

Table 3 presents the within-group mean (95% confidence interval)change scores between baseline and 3- and 6-month follow-up and

Table 3 Outcome measure change score results from baseline at 3- an

Outcome Measure WP

Sleep measures

PSQI

3mo �1.06 (�3.05 to 0.93)

Effect size (d) .402 (nZ17)

6mo �1.40 (�3.29 to 0.49)

Effect size (d) .262 (nZ15)

ISI

3mo �1.24 (�4.39 to 1.92)

Effect size (d) .333 (nZ17)

6mo �0.20 (�2.09 to 1.70)

Effect size (d) .161 (nZ15)

LBP measures

ODI

3mo �3.35 (�8.97 to 2.26)

6mo �2.47 (�10.61 to 5.67)

NRS

Average back pain

3mo �0.68 (�2.10 to 0.75)

6mo 0.10 (�1.04 to 1.24)

NRS

Average leg pain

3mo 0.50 (�0.73 to 1.73)

6mo 0.77 (�0.14 to 1.67)

Biopsychosocial measures

HADS (anxiety)

3mo �0.47 (�1.72 to 0.78)

6mo 0.27 (�1.45 to 1.88)

HADS (depression)

3mo �0.41 (�1.71 to 0.89)

6mo 0.21 (�1.89 to 2.32)

FABQ-PA

3mo �1.94 (�4.63 to 0.75)

6mo �3.07 (�5.96 to 0.17)

SF-36 V2 (PCS)

3mo 0.39 (�4.03 to 4.80)

6mo �1.11 (�6.17 to 3.96)

SF-36 V2 (MCS)

3mo �0.38 (�6.21 to 5.45)

6mo �0.09 (�5.03 to 4.85)

NOTE. Data are presented as mean � 95% confidence interval or as otherwis

Abbreviations: FABQ-PA, Fear-Avoidance Beliefs Questionnaire-physical activit

score; NRS, Numeric Rating Scale; ODI, Oswestry Disability Index; PCS, physi

Form Health Survey version 2.

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the associated within-group effect sizes for the sleep outcomemeasures. There were improvements in PSQI and ISI scores in allgroups at both follow-up points, with predominantly mediumeffect sizes evident (ie, Cohen dZ0.2e0.5). There were similarpercentages demonstrating an MCID on the PSQI (�3) at 3months (WP: 35.3%, nZ6 of 17; SEC: 28.6%, nZ4 of 14; UP:38.5%, nZ5 of 13) and 6 months (WP: 40.0%, nZ6 of 15; SEC:38.5%, nZ5 of 12; UP: 30.8%, nZ4 of 13).

LBP and functional disability outcomes also improved in allgroups, apart from slight worsening of the average back pain scorein the WP group at 6 months. The proportion of participantsachieving an MCID on the Oswestry Disability Index (�10) washighest in the UP group (3mo: 53.8%, nZ7; 6mo: 46.2%, nZ6),

d 6-month follow-up

SEC UP

�1.14 (�2.92 to 0.64) �1.54 (�3.63 to 0.55)

.330 (nZ14) .437 (nZ13)

�0.69 (�2.67 to 1.29) �0.31 (�2.89 to 2.27)

.136 (nZ14) .049 (nZ13)

�2.21 (�4.84 to 0.41) �2.92 (�6.04 to 0.19)

.215 (nZ14) .648 (nZ13)

�2.33 (�6.31 to 1.64) �0.85 (�2.75 to 1.06)

.37 (nZ13) .393 (nZ13)

�7.14 (�15.63 to 1.35) �9.06 (�18.31 to 0.19)

�2.00 (�12.30 to 8.30) �5.53 (�15.07 to 4.01)

�0.68 (�1.58 to 0.22) �1.96 (�3.53 to 0.39)

�1.00 (�2.41 to 0.34) �2.08 (�4.11 to 0.47)

0.43 (�1.33 to 2.19) �0.31 (�2.65 to 2.04)

0.81 (�1.25 to 2.87) 0.19 (�2.40 to 2.78)

�0.31 (�1.86 to 1.24) �1.38 (�3.40 to 0.63)

�0.89 (�3.01 to 1.23) �1.45 (�2.81 to �0.10)

�0.15 (�1.71 to 1.40) �1.38 (�3.17 to 0.40)

�0.11 (�2.64 to 2.42) �0.45 (�1.84 to 0.93)

�4.00 (�9.45 to 1.45) �0.08 (�4.87 to 4.72)

�4.82 (�10.34 to 0.70) �0.77 (�2.10 to 3.64)

6.12 (�0.21 to 12.48) 3.18 (�0.43 to 6.80)

1.16 (�2.75 to 5.07) 1.24 (�4.06 to 6.55)

5.31 (0.95 to 9.68) 1.86 (�3.26 to 6.99)

3.54 (�3.14 to 10.23) 2.99 (�4.03 to 10.02)

e noted.

y; HADS, Hospital Anxiety and Depression Scale; MCS, mental component

cal component score; SF-36 V2, Medical Outcomes Study 36-Item Short-

2090 J. Eadie et al

followed by the SEC (3mo: 50%, nZ7; 6mo: 38.5%, nZ5) andthe WP (3mo: 29.4%, nZ5; 6mo: 26.7%, nZ4).

Almost all participants in each group were at least somewhatsatisfied with the overall care (WP: nZ15 of 16 vs SEC: nZ7 of 7vs UP: nZ10 of 10) and the treatment they received for CLBP inthe study (WP: nZ13 of 16 vs SEC: nZ7 of 7 vs UP: nZ10 of10), which they reported was at least of some benefit (WP: nZ9 of16 vs SEC: nZ7 of 7 vs UP: nZ9 of 10).

Discussion

The findings confirmed the high point prevalence of sleepdisturbance in health care seeking people with CLBP, suggestingrecruitment to future trials is feasible. However, participantretention and compliance with sleep measurement in the homeenvironment at follow-up proved challenging and would need tobe addressed to maximize outcome responsiveness. The treatmenteffects observed for sleep outcomes were similarly positiveregardless of the physiotherapy approach.

The high PSQI scores of most of the sample were consistentwith previous studies in this population,33,50 but less than half of thesample was classified as having clinical insomnia on the ISI.Therefore, the PSQI would be a more useful screening tool in futuretrials. Further refinement of the inclusion criteria using suitable cutpoints (PSQI �5) to ensure greater homogeneity of the sample andthe recruitment of only those with significant LBP-related sleepdisturbance is also warranted. Baseline mean SE was over 85% onthe Actiwatch and the PSD, which is considered within normativelimits (�85%),51 and is consistent with previous actigraphy studiesin CLBP.52-55 The TST ranged from 6.4 (PSD) to 6.9 (Actiwatch)hours, whereas the sleep onset latency was longer (25.2min)according to the PSD than the Actiwatch (14.8min). These differ-ences between self-reported and objective sleep may be partlyexplained by inconsistency between participants’ recall of theirsleep quality and the presence of quiet wakefulness categorized assleep by actigraphy,43 thus highlighting the need to continue tocollect both outcomes in future RCTs. However, the poor compli-ance with the sleep measures over a 7-night period, as recom-mended by the American Academy of Sleep Medicine,56 should beaddressed. Several participants found the Actiwatch intrusive andbelieved it negatively affected their sleep, thus consideration shouldbe given to using noncontact and less obtrusive monitoring devices(SleepMinder, SenseWear).57 Similarly, the recent developments inmobile tablet and phone technology that incorporate electronicdiary apps58 and automatic prompts for nonrespondents59 have thepotential to improve the rate of completion of sleep diaries.

The consistent positive, albeit small, improvements in sleepoutcomes observed provide preliminary evidence of the effect ofseveral physiotherapy approaches on sleep disturbance in a sampleof people with CLBP. Similarly, there were generally positiveimprovements in the LBP and biopsychosocial outcomes, whichhave been previously investigated by some members of theteam.60,61 However, the current interventions were not primarilydesigned to target sleep disturbance, and given the growingevidence for the effectiveness of cognitive behavioral therapy forinsomnia secondary to chronic pain,62,63 and the purportedreciprocal relation between pain and sleep disturbance,64 anyfuture trials of physiotherapy may yield larger improvements insleep outcomes by including cognitive behavioral therapy forinsomnia within the physiotherapy intervention. Based on thecurrent findings, and considering the continued use of the PSQI as

the primary outcome measure for any future trial, one can antic-ipate a mean change of at least 1 unit with an SD of 3.5 units onthis measure for any of the current interventions. A study with 98participants (nZ49 per group), which compared any of theseinterventions to a cognitive behavioral therapy for insomniainformed-physiotherapy intervention for back pain, will berequired for 80% power to detect a raw between-group meandifference of 2 PSQI points,65 with a level of significance of .05based on a 2-sample t test at follow-up. To account for attritionbased on the results of this feasibility trial (30% loss to follow-up),128 subjects (nZ64 per group) would be required.

Study limitations

The small sample size and low statistical powermean that the resultsshould be interpretedwith caution, but it is justified by the feasibilitynature of the study, which resulted in a power calculation for a maintrial. A second limitation is the high attrition rate during the follow-up period, which is comparable with previous clinical trials inpublic physiotherapy in Ireland,21 and was anticipated in the studydesign.12 Finally, the poor compliance with the Actiwatch and thePSD is a limitation which warrants further investigation.

Conclusions

This study provides important feasibility considerations for a fullypowered trial, including stringent screening procedures to targetappropriate participants with sleep disturbance, strategies tominimize attrition rates, and strategies to maximize compliancewith sleep outcome measures over extended time periods in theparticipants’ home environment.

Suppliers

a. Great Performance Ltd, 59 Holland Gardens, Brentford,London, TW8 OBF, UK

b. Linton Instrumentation, Unit 11, Forge Business Centre, UpperRose Lane, Palgrave, Diss, Norfolk, IP22 1AP, UK.

c. Predictive Analytics Software (PASW); IBM Corp, 1 NewOrchard Rd, Armonk, NY 10504-1722.

Keywords

Actigraphy; Dyssomnias; Low back pain; Physical therapyspecialty; Rehabilitation

Corresponding author

Deirdre A. Hurley, PhD, Institute for Sport and Health, School ofPublic Health, Physiotherapy and Population Science, UniversityCollege Dublin, Dublin 4, Ireland. E-mail address: deirdre.hurleyosing@ucd.ie.

Acknowledgments

We thank the physiotherapy staff of Beaumont Hospital, Dublin,Ireland, who treated patients in the study. We also thank Tim

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Physiotherapy for sleep disturbance in low back pain 2091

Grant, MSc, Centre for Support and Training in Analysis andResearch, University College Dublin for statistical advice.

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