Skip to main content Accessibility help
×
×
Home

Efficacy of a Sleep Quality Intervention in People With Low Back Pain: Protocol for a Feasibility Randomized Co-Twin Controlled Trial

  • Marina B. Pinheiro (a1), Kevin K. Ho (a1), Manuela L. Ferreira (a2), Kathryn M. Refshauge (a1), Ron Grunstein (a3), John L. Hopper (a4), Christopher G. Maher (a5), Bart W. Koes (a6), Juan R. Ordoñana (a7) and Paulo H. Ferreira (a1)...
Abstract

Poor sleep quality is highly prevalent in patients with low back pain (LBP) and is associated with high levels of pain, psychological distress, and physical disability. Studies have reported a bidirectional relationship between sleep problems and intensity of LBP. Accordingly, effective management of LBP should address sleep quality. In addition, genetics has been found to significantly affect the prevalence of both LBP and insomnia. Our study aims to establish the feasibility of a trial exploring the efficacy of a web-based sleep quality intervention in people with LBP, with the genetic influences being controlled for. 30 twins (15 complete pairs) with subacute or chronic LBP (>6 weeks) will be recruited from the Australian Twin Registry. Participants will be randomly assigned to one of the two groups with each twin within a pair receiving either an interactive web-based sleep intervention based on cognitive behavioral therapy principles (intervention) or a web-based education program (control) for 6 weeks. The feasibility of the trial will be investigated with regard to recruitment rate, feasibility of data collection and outcome measure completion, contamination of intervention, acceptability and experience of intervention, and sample size requirement for the full trial. Patient outcomes will be collected electronically at baseline, immediately post-treatment, and at 3-months’ follow-up post-randomization. This trial employs a robust design that will effectively control for the influence of genetics on treatment effect. Additionally, this study addresses sleep quality, a significant but under-explored issue in LBP. Results will inform the design and implementation of the definitive trial.

  • View HTML
    • Send article to Kindle

      To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle.

      Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

      Find out more about the Kindle Personal Document Service.

      Efficacy of a Sleep Quality Intervention in People With Low Back Pain: Protocol for a Feasibility Randomized Co-Twin Controlled Trial
      Available formats
      ×
      Send article to Dropbox

      To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Dropbox.

      Efficacy of a Sleep Quality Intervention in People With Low Back Pain: Protocol for a Feasibility Randomized Co-Twin Controlled Trial
      Available formats
      ×
      Send article to Google Drive

      To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Google Drive.

      Efficacy of a Sleep Quality Intervention in People With Low Back Pain: Protocol for a Feasibility Randomized Co-Twin Controlled Trial
      Available formats
      ×
Copyright
Corresponding author
address for correspondence: Marina B. Pinheiro, Faculty of Health Sciences, The University of Sydney, 75 East Street, Lidcombe, Sydney NSW 2141, Australia. E-mail: mdeb9852@uni.sydney.edu.au
References
Hide All
Alsaadi, S. M., McAuley, J. H., Hush, J. M., Lo, S., Bartlett, D. J., Grunstein, R. R., & Maher, C. G. (2014a). The bidirectional relationship between pain intensity and sleep disturbance/quality in patients with low back pain. Clinical Journal of Pain, 30, 755765.
Alsaadi, S. M., McAuley, J. H., Hush, J. M., Lo, S., Lin, C. W. C., Williams, C. M., & Maher, C. G. (2014b). Poor sleep quality is strongly associated with subsequent pain intensity in patients with acute low back pain. Arthritis & Rheumatology, 66, 13881394.
Alsaadi, S. M., McAuley, J. H., Hush, J. M., & Maher, C. G. (2012). Erratum to: Prevalence of sleep disturbance in patients with low back pain. European Spine Journal, 21, 554560.
Altman, D. G., Schulz, K. F., Moher, D., Egger, M., Davidoff, F., Elbourne, D., . . . Consort, G. (2001). The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Annals of Internal Medicine, 134, 663694.
Arthritis and Osteoporosis Victoria. (2013). A problem worth solving. The rising cost of musculoskeletal conditions in Australia. Elsternwick: Arthritis and Osteoporosis Victoria.
Australian Institute of Health and Welfare. (2004). Eighth biennial health report of the Australian institute of health and welfare. Canberra, Australia: Author.
Barclay, N. L., Eley, T. C., Buysse, D. J., Rijsdijk, F. V., & Gregory, A. M. (2010). Genetic and environmental influences on different components of the Pittsburgh sleep quality index and their overlap. Sleep: Journal of Sleep and Sleep Disorders Research, 33, 659668.
Bastien, C. H., Vallieres, A., & Morin, C. M. (2001). Validation of the insomnia severity index as an outcome measure for insomnia research. Sleep Medicine, 2, 297307.
Baumeister, H., Knecht, A., & Hutter, N. (2012). Direct and indirect costs in persons with chronic back pain and comorbid mental disorders — A systematic review. Journal of Psychosomatic Research, 73, 7985.
Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of Behavior Therapy and Experimental Psychiatry, 3, 257260.
Browne, R. H. (1995). On the use of a pilot sample for sample size determination. Statistics in Medicine, 14, 19331940.
Chan, A. W., Tetzlaff, J. M., Altman, D. G., Laupacis, A., Gotzsche, P. C., Krleza-Jeric, K., . . . Moher, D. (2013). SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Annals of Internal Medicine, 158, 200207.
Dupont, W. D. (1988). Power calculations for matched case-control studies. Biometrics, 44, 11571168.
Espie, C. A., Kyle, S. D., Hames, P., Gardani, M., Fleming, L., & Cape, J. (2014). The sleep condition indicator: A clinical screening tool to evaluate insomnia disorder. BMJ Open, 4, e004183.
Espie, C. A., Kyle, S. D., Williams, C., Ong, J. C., Douglas, N. J., Hames, P., & Brown, J. S. (2012). A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep, 35, 769781.
Everitt, B. S., & Howell, D. C. (2005). Co-twin control methods. In Everitt, B. S. (Ed.), Encyclopedia of statistics in behavioral science. Vol. 1 (pp. 415418). West Sussex, UK: Wiley.
Ferreira, M. L., Ferreira, P. H., Latimer, J., Herbert, R. D., Hodges, P. W., Jennings, M. D., . . . Refshauge, K. M. (2007). Comparison of general exercise, motor control exercise and spinal manipulative therapy for chronic low back pain: A randomized trial. Pain, 131, 3137.
Ferreira, P. H., Beckenkamp, P., Maher, C. G., Hopper, J. L., & Ferreira, M. L. (2013). Nature or nurture in low back pain? Results of a systematic review of studies based on twin samples. European Journal of Pain, 17, 957971.
Ferreira, P. H., Ferreira, M. L., Maher, C. G., Herbert, R. D., & Refshauge, K. (2006). Specific stabilisation exercise for spinal and pelvic pain: A systematic review. Australian Journal of Physiotherapy, 52, 7988.
Freburger, J. K., Carey, T. S., Holmes, G. M., Wallace, A. S., Castel, L. D., Darter, J. D., & Jackman, A. M. (2009). Exercise prescription for chronic back or neck pain: Who prescribes it? Who gets it? What is prescribed?. Arthritis & Rheumatology, 61, 192200.
Gottlieb, D. J., O'Connor, G. T., & Wilk, J. B. (2007). Genome-wide association of sleep and circadian phenotypes. BMC Medical Genetics, 8, S9.
Hall, A. M., Maher, C. G., Latimer, J., Ferreira, M. L., & Costa, L. O. (2011). The patient-specific functional scale is more responsive than the Roland Morris disability questionnaire when activity limitation is low. European Spine Journal, 20, 7986.
Harris, P. A., Taylor, R., Thielke, R., Payne, J., Gonzalez, N., & Conde, J. G. (2009). Research Electronic Data Capture (REDCap) — A metadata-driven methodology and workflow process for providing translational research informatics support. Journal of Biomedical Informatics, 42, 377381.
Heath, A. C., Kendler, K. S., Eaves, L. J., & Martin, N. G. (1990). Evidence for genetic influences on sleep disturbance and sleep pattern in twins. Sleep, 13, 318335.
Henry, J. D., & Crawford, J. R. (2005). The short-form version of the Depression Anxiety Stress Scales (DASS-21): Construct validity and normative data in a large non-clinical sample. British Journal of Clinical Psychology, 44, 227239.
Hoffmann, T. C., Glasziou, P. P., Boutron, I., Milne, R., Perera, R., Moher, D., . . . Michie, S. (2014). Better reporting of interventions: Template for intervention description and replication (TIDieR) checklist and guide. British Medical Journal, 348, g1687.
Hunter, D., Major, P., Arden, N., Swaminathan, R., Andrew, T., MacGregor, A. J., . . . Spector, T. D. (2000). A randomized controlled trial of vitamin D supplementation on preventing postmenopausal bone loss and modifying bone metabolism using identical twin pairs. Journal of Bone and Mineral Research, 15, 22762283.
Jungquist, C. R., O'Brien, C., Matteson-Rusby, S., Smith, M. T., Pigeon, W. R., Xia, Y., . . . Perlis, M. L. (2010). The efficacy of cognitive-behavioral therapy for insomnia in patients with chronic pain. Sleep Medicine, 11, 302309.
Kelly, G. A., Blake, C., Power, C. K., O'Keeffe, D., & Fullen, B. M. (2011). The association between chronic low back pain and sleep: A systematic review. Clinical Journal of Pain, 27, 169181.
Kundermann, B., Krieg, J. C., Schreiber, W., & Lautenbacher, S. (2004). The effect of sleep deprivation on pain. Pain Research and Management, 9, 2532.
Lee, P. H., Macfarlane, D. J., Lam, T. H., & Stewart, S. M. (2011). Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): A systematic review. International Journal of Behavioral Nutrition and Physical Activity, 8, 115.
Machado, L. A., Kamper, S. J., Herbert, R. D., Maher, C. G., & McAuley, J. H. (2009). Analgesic effects of treatments for non-specific low back pain: A meta-analysis of placebo-controlled randomized trials. Rheumatology (Oxford), 48, 520527.
Martin, N. G., Carr, A. B., Oakeshott, J. G., & Clark, P. (1982). Co-twin control studies: Vitamin C and the common cold. Progress in Clinical and Biological Research, 103 Pt A, 365373.
McCracken, L. M., & Iverson, G. L. (2002). Disrupted sleep patterns and daily functioning in patients with chronic pain. Pain Research and Management, 7, 7579.
Nicholas, M. K., Wilson, P. H., & Goyen, J. (1992). Comparison of cognitive-behavioral group treatment and an alternative non-psychological treatment for chronic low back pain. Pain, 48, 339347.
Novak, M., Mucsi, I., Shapiro, C. M., Rethelyi, J., & Kopp, M. S. (2004). Increased utilization of health services by insomniacs — An epidemiological perspective. Journal of Psychosomatic Research, 56, 527536.
Reynolds, C. F. 3rd, Redline, S., Workgroup, D.-V. S.-W. D., & Advisors. (2010). The DSM-5 sleep-wake disorders nosology: An update and an invitation to the sleep community. Journal of Clinical Sleep Medicine, 6, 910.
Riemann, D., & Perlis, M. L. (2009). The treatments of chronic insomnia: A review of benzodiazepine receptor agonists and psychological and behavioral therapies. Sleep Medicine Reviews, 13, 205214.
Roland, M., & Fairbank, J. (2000). The Roland-Morris disability questionnaire and the oswestry disability questionnaire. Spine (Phila Pa 1976), 25, 31153124.
Ronkainen, P. H., Kovanen, V., Alen, M., Pollanen, E., Palonen, E. M., Ankarberg-Lindgren, C., . . . Sipila, S. (2009). Postmenopausal hormone replacement therapy modifies skeletal muscle composition and function: A study with monozygotic twin pairs. Journal of Applied Physiology (1985), 107, 2533.
Ropponen, A., Silventoinen, K., Hublin, C., Svedberg, P., Koskenvuo, M., & Kaprio, J. (2013). Sleep patterns as predictors for disability pension due to low back diagnoses: A 23-year longitudinal study of Finnish twins. Sleep, 36, 891897.
Schutte-Rodin, S., Broch, L., Buysse, D., Dorsey, C., & Sateia, M. (2008). Clinical guideline for the evaluation and management of chronic insomnia in adults. Journal of Clinical Sleep Medicine, 4, 487504.
Scrimshaw, S. V., & Maher, C. (2001). Responsiveness of visual analogue and McGill pain scale measures. Journal of Manipulative and Physiological Therapeutics, 24, 501504.
Seyffert, M., Lagisetty, P., Landgraf, J., Chopra, V., Pfeiffer, P. N., Conte, M. L., & Rogers, M. A. M. (2016). Internet-delivered cognitive behavioral therapy to treat insomnia: A systematic review and meta-analysis. PLoS ONE, 11, e0149139.
Smeets, R. J., Beelen, S., Goossens, M. E., Schouten, E. G., Knottnerus, J. A., & Vlaeyen, J. W. (2008). Treatment expectancy and credibility are associated with the outcome of both physical and cognitive-behavioral treatment in chronic low back pain. Clinical Journal of Pain, 24, 305315.
Tang, N. K., Lereya, S. T., Boulton, H., Miller, M. A., Wolke, D., & Cappuccio, F. P. (2015). Nonpharmacological treatments of insomnia for long-term painful conditions: A systematic review and meta-analysis of patient-reported outcomes in randomized controlled trials. Sleep, 38, 17511764.
Thabane, L., Ma, J., Chu, R., Cheng, J., Ismaila, A., Rios, L. P., . . . Goldsmith, C. H. (2010). A tutorial on pilot studies: The what, why and how. BMC Medical Research Methodology, 10, 1.
Trauer, J. M., Qian, M. Y., Doyle, J. S., Rajaratnam, S. M., & Cunnington, D. (2015). Cognitive behavioral therapy for chronic insomnia: A systematic review and meta-analysiscognitive behavioral therapy for chronic insomnia. Annals of Internal Medicine, 163, 191204.
Visscher, P. M., Gordon, S., & Neale, M. C. (2008). Power of the classical twin design revisited: II detection of common environmental variance. Twin Research and Human Genetics, 11, 4854.
Vitiello, M. V., McCurry, S. M., Shortreed, S. M., Baker, L. D., Rybarczyk, B. D., Keefe, F. J., & Von Korff, M. (2014). Short-term improvement in insomnia symptoms predicts long-term improvements in sleep, pain, and fatigue in older adults with comorbid osteoarthritis and insomnia. Pain, 155, 15471554.
Vitiello, M. V., Rybarczyk, B., Von Korff, M., & Stepanski, E. J. (2009). Cognitive behavioral therapy for insomnia improves sleep and decreases pain in older adults with co-morbid insomnia and osteoarthritis. Journal of Clinical Sleep Medicine, 5, 355362.
Walker, B. F. (2000). The prevalence of low back pain: A systematic review of the literature from 1966 to 1998. Journal of Spinal Disorders, 13, 205217.
Watson, N. F., Harden, K. P., Buchwald, D., Vitiello, M. V., Pack, A. I., Strachan, E., & Goldberg, J. (2014). Sleep duration and depressive symptoms: A gene-environment interaction. Sleep, 37, 351358.
Recommend this journal

Email your librarian or administrator to recommend adding this journal to your organisation's collection.

Twin Research and Human Genetics
  • ISSN: 1832-4274
  • EISSN: 1839-2628
  • URL: /core/journals/twin-research-and-human-genetics
Please enter your name
Please enter a valid email address
Who would you like to send this to? *
×

Keywords

Metrics

Altmetric attention score

Full text views

Total number of HTML views: 0
Total number of PDF views: 0 *
Loading metrics...

Abstract views

Total abstract views: 0 *
Loading metrics...

* Views captured on Cambridge Core between <date>. This data will be updated every 24 hours.

Usage data cannot currently be displayed