Contact information
Type
Scientific
Primary contact
Dr Deirdre Hurley
ORCID ID
Contact details
UCD School of Physiotherapy and Performance Science
Health Sciences Centre
University College Dublin
Belfield
Dublin
4
Ireland
+353 (0)1 716 6515
deirdre.hurleyosing@ucd.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2007-16
Study information
Scientific title
The effectiveness of three forms of physiotherapy for sleep disturbance in chronic low back pain: a pilot single-blinded randomised controlled trial
Acronym
SLEEP
Study hypothesis
There will be a difference in the effects of a supervised exercise class, usual physiotherapy and a walking programme on sleep disturbance in chronic low back pain.
Ethics approval
Beaumont Hospital Ethics (Medical Research) Committee approved in October 2008
Study design
Single-blinded feasibility randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic low back pain
Intervention
1. Supervised exercise class (SEC):
Within one week of randomisation, participants will commence the SEC. This class will follow a group-based format based on the 'Back to Fitness' programme used in the UK BEAM trial and endorsed by the recent NICE guidelines for persistent low back pain. Each participant will attend the Physiotherapy Department for an initial individual assessment prior to the class, where there will be discussion and agreement between the Therapist and the patient on short and long-term goals; recording of the patient's exercise capabilities and perceived barriers to recovery and the individual's treatment expectations. Participants will then attend the Physiotherapy Department of Beaumont Hospital once a week for 8 weeks for a one-hour supervised group exercise class led by a Chartered Physiotherapist. The Physiotherapist will advise patients according to their individual goals and exercise capabilities, and help identify which exercise(s) they could continue independently of the group sessions, i.e. foster the development of self-management strategies. Subjects will also be required to rate their perceived exertion during the class on the Borg scale. Patients will be encouraged to accept responsibility for determining and carrying out their weekly programme of activity. Adherence with the SEC will be recorded as the number of sessions attended.
2. Walking programme (WP):
Within one week of randomisation participants will commence participation in the WP at Beaumont Hospital through an appointment with a Chartered Physiotherapist. The focus will be on increasing physical activity through a graded walking programme. As with the SEC (see above), each participant will attend the Physiotherapy Department for an individual initial assessment, where there will be discussion and agreement between the therapist and the patient on short and long-term goals; recording of the patient's exercise capabilities and perceived barriers to recovery and the individual's treatment expectations. Each subject will be given a Yamax Digiwalker Pedometer to record habitual daily activity levels and instructed in its use. A starting point for the eight week progressive walking programme will be established; the minimum being a 10-minute walk (approx 1200 steps) on at least four days per week to be decided with, where possible, one day's rest between walks. The aim of the programme is to progress to the ACSM guidelines of 30 minutes moderate intensity walking on five days per week by week five and then to maintain this level for the remainder of the programme. All participants will use their pedometer as a motivational feedback tool, providing immediate information on activity levels. Adherence with the walking programme will be assessed by the frequency, distance, number of steps taken and duration of walks recorded in a training diary.
The subjects will then be contacted once per week by the Chartered Physiotherapist who performed the initial assessment by telephone to progress their walking frequency and duration and provide encouragement, and will reattend the Physiotherapy Department at the end of the intervention for reassessment and discharge from physiotherapy.
3. Usual physiotherapy (UP - control group):
Within one week of randomisation, participants randomised to the UP group will commence individual physiotherapy at the discretion of the treating Physiotherapist in Beaumont Hospital. All physiotherapy treatments will be recorded for the study period in previously designed treatment record forms. On the basis of a previous RCT by the research team in the Republic of Ireland Public Physiotherapy Health Service the anticipated mean (SD) number of treatments is 5.8 (3) over a mean (SD) of 7.7 weeks (5.8) weeks. A multimodal approach of education/advice, manipulative therapy and exercise therapy will be permitted on the basis of the results of previous surveys of physiotherapy practice in the UK and Ireland. As part of this it is expected that subjects will be provided with an individualised exercise programme at the discretion of the treating Therapist but will not be permitted to attend group exercise classes or undertake a supervised walking programme during the trial. Adherence will be assessed by the number of visits prior to discharge from physiotherapy.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Self-reported sleep quality using the Pittsburgh Sleep Quality Index, Insomnia Severity Index, and the Pittsburgh Sleep Diary
2. Objective sleep quality using the Actiwatch (Model AW4, CamNTech, Cambridge, UK) on all patients and the Sleep Minder (BiancaMed Ltd, Dublin, Ireland) on a sample of the patients recruited on two separate occasions each lasting seven nights:
2.1. At baseline, and
2.2. Three months after initial randomisation
3. Functional disability due to LBP measured by the Oswestry Disability Index (ODI)
4. Pain using Numerical Rating Scales for current and average pain for both back and leg pain
5. Health-related quality of life measured by the 36-item Short-Form, Version 2 questionnaire
6. Psycho-social beliefs using the Fear Avoidance Beliefs Questionnaire and the Anxiety and Depression using the Hospital Anxiety and Depression Scale
7. Employment status and number of days reported sick leave over the past year for those in paid employment only
8. Self-report physical activity levels using the International Physical Activity Questionnaire (IPAQ)
9. Exercise self efficacy questionnaire
10. Patient satisfaction will be assessed using Likert scales assessing satisfaction with outcome and satisfaction with care at 3 months only
All outcomes are measured at baseline, 3 and 6 months, apart from objective sleep measures of actiwatch and sleep minder (baseline and 3 months) and patient satisfaction (3 months).
Secondary outcome measures
No secondary outcome measures
Overall trial start date
23/10/2008
Overall trial end date
28/02/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Males/females aged between 18 - 70 years
2. Patients with chronic (greater than or equal to 3 months) or recurrent (greater than or equal to three episodes in the previous 12 months) low back pain (LBP) of mechanical origin with/without radiation to the lower limb
3. No spinal surgery within the previous 12 months
4. Patients deemed suitable by their GP/hospital consultant to carry out an exercise programme
5. Patients willing to attend for an 8-week treatment programme of exercise classes
6. Fluency in English (verbal and written)
7. Access to a telephone (for follow-up support)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Clinically diagnosed primary sleep disorder, e.g., sleep apnoea, insomnia
2. Currently on sleeping medication
3. Currently or having received treatment for CLBP within previous 3 months
4. Patients with minimum disability on the Oswestry Disability Index (less than 10)
5. Red flags indicating serious spinal pathology, e.g., cancer, cauda equina lesion
6. Radicular pain indicative of nerve root compression
7. Patients diagnosed with severe spinal stenosis, spondylolisthesis, fibromyalgia
8. History of systemic/inflammatory disease, e.g., rheumatoid arthritis
9. Patients with any confounding conditions such as a neurological disorder or currently receiving treatment for cancer
10. Patients with acute (less than 6 weeks) or subacute LBP (6 - 12 weeks), provided that they have experienced less than three LBP episodes during previous 12 months
11. Unstable angina/uncontrolled cardiac dysrhythmias/severe aortic stenosis/acute systemic infection accompanied by fever
12. Medico-legal issues
13. Pregnancy
Recruitment start date
23/10/2008
Recruitment end date
28/02/2010
Locations
Countries of recruitment
Ireland
Trial participating centre
UCD School of Physiotherapy and Performance Science
Dublin
4
Ireland
Sponsor information
Organisation
Health Research Board (HRB) (Ireland)
Sponsor details
73 Lower Baggot Street
Dublin
2
Ireland
+353 (0)1 234 5000
hrb@hrb.ie
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Research Board (HRB) (Ireland) - Partnership Award (ref: 2007-16)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20398349
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23643716
Publication citations
-
Protocol
Hurley DA, Eadie J, O'Donoghue G, Kelly C, Lonsdale C, Guerin S, Tully MA, van Mechelen W, McDonough SM, Boreham CA, Heneghan C, Daly L, Physiotherapy for sleep disturbance in chronic low back pain: a feasibility randomised controlled trial., BMC Musculoskelet Disord, 2010, 11, 70, doi: 10.1186/1471-2474-11-70.
-
Results
Eadie J, van de Water AT, Lonsdale C, Tully MA, van Mechelen W, Boreham CA, Daly L, McDonough SM, Hurley DA, Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial., Arch Phys Med Rehabil, 2013, 94, 11, 2083-2092, doi: 10.1016/j.apmr.2013.04.017.