Randomized controlled trial of a 12-week digital care program in improving low back pain

Low back pain (LBP) is the leading cause of disability throughout the world and is economically burdensome. The recommended first line treatment for non-specific LBP is non-invasive care. A digital care program (DCP) delivering evidence-based non-invasive treatment for LBP can aid self-management by engaging patients and scales personalized therapy for patient-specific needs. We assessed the efficacy of a 12-week DCP for LBP in a two-armed, pre-registered, randomized, controlled trial (RCT). Participants were included based on self-reported duration of LBP, but those with surgery or injury to the lower back in the previous three months were excluded. The treatment group (DCP) received the 12-week DCP, consisting of sensor-guided exercise therapy, education, cognitive behavioral therapy, team and individual behavioral coaching, activity tracking, and symptom tracking – all administered remotely via an app. The control group received three digital education articles only. All participants maintained access to treatment-as-usual. At 12 weeks, an intention-to-treat analysis showed each primary outcome—Oswestry Disability Index (p < 0.001), Korff Pain (p < 0.001) and Korff Disability (p < 0.001)—as well as each secondary outcome improved more for participants in the DCP group compared to control group. For participants who completed the DCP (per protocol), average improvement in pain outcomes ranged 52-64% (Korff: 48.8–23.4, VAS: 43.6–16.5, VAS impact on daily life: 37.3–13.4; p < 0.01 for all) and average improvement in disability outcomes ranged 31–55% (Korff: 33.1–15, ODI: 19.7–13.5; p < 0.01 for both). Surgical interest significantly reduced in the DCP group. Participants that completed the DCP had an average engagement, each week, of 90%. Future studies will further explore the effectiveness of the DCP for long-term outcomes beyond 12 weeks and for a LBP patient population with possibly greater baseline pain and disability. In conclusion, the DCP resulted in improved LBP outcomes compared to treatment-as-usual and has potential to scale personalized evidence-based non-invasive treatment for LBP patients.

[1]  Roy J. Shephard,et al.  Leisure Time Exercise Questionnaire , 2015 .

[2]  Simon Hunter,et al.  Translating Comprehensive Conservative Care for Chronic Knee Pain Into a Digital Care Pathway: 12-Week and 6-Month Outcomes for the Hinge Health Program , 2017, JMIR rehabilitation and assistive technologies.

[3]  D. Bates,et al.  Fitting Linear Mixed-Effects Models Using lme4 , 2014, 1406.5823.

[4]  T. Tölle,et al.  Treatment of Low Back Pain with a Digital Multidisciplinary Pain Treatment App: Short-Term Results , 2017, JMIR rehabilitation and assistive technologies.

[5]  Short-term effect on pain and function of neurophysiological education and sensorimotor retraining compared to usual physiotherapy in patients with chronic or recurrent non-specific low back pain, a pilot randomized controlled trial , 2016 .

[6]  B. Ni,et al.  Surgical versus nonsurgical treatment of chronic low back pain: A meta-analysis based on current evidence. , 2016, Journal of back and musculoskeletal rehabilitation.

[7]  K. Carpenter,et al.  An Online Self-help CBT Intervention for Chronic Lower Back Pain , 2012, The Clinical journal of pain.

[8]  S. Takemoto,et al.  Value-based Care in the Management of Spinal Disorders: A Systematic Review of Cost-utility Analysis , 2012, Clinical orthopaedics and related research.

[9]  Kelly-Ann Bowles,et al.  Cost-effectiveness of using a motion-sensor biofeedback treatment approach for the management of sub-acute or chronic low back pain: economic evaluation alongside a randomised trial , 2017, BMC Musculoskeletal Disorders.

[10]  A. Starkweather,et al.  Low back pain. , 2015, Nursing.

[11]  Gbd Disease and Injury Incidence and Prevalence Collab.  Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016 , 2017 .

[12]  Bradley J. Wright,et al.  Non-adherence to prescribed home rehabilitation exercises for musculoskeletal injuries: the role of the patient-practitioner relationship. , 2014, Journal of rehabilitation medicine.

[13]  Nancy W Glynn,et al.  A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial. , 2016, JAMA internal medicine.

[14]  T. Hansson,et al.  The Effects of Common Medical Interventions on Pain, Back Function, and Work Resumption in Patients With Chronic Low Back Pain: A Prospective 2-Year Cohort Study in Six Countries , 2000, Spine.

[15]  Simon Hunter,et al.  Effects of a 12-Week Digital Care Program for Chronic Knee Pain on Pain, Mobility, and Surgery Risk: Randomized Controlled Trial , 2018, Journal of medical Internet research.

[16]  J. Kool,et al.  Short-term effect on pain and function of neurophysiological education and sensorimotor retraining compared to usual physiotherapy in patients with chronic or recurrent non-specific low back pain, a pilot randomized controlled trial , 2015, BMC Musculoskeletal Disorders.

[17]  Martin Underwood,et al.  Prevention and treatment of low back pain: evidence, challenges, and promising directions , 2018, The Lancet.

[18]  M. Nordin,et al.  The Global Spine Care Initiative: applying evidence-based guidelines on the non-invasive management of back and neck pain to low- and middle-income communities , 2018, European Spine Journal.

[19]  J. Hibbard,et al.  Why Does Patient Activation Matter? An Examination of the Relationships Between Patient Activation and Health-Related Outcomes , 2012, Journal of General Internal Medicine.

[20]  Arianne P Verhagen,et al.  Exercise therapy for chronic nonspecific low-back pain. , 2010, Best practice & research. Clinical rheumatology.

[21]  Karen Søgaard,et al.  Digital Support Interventions for the Self-Management of Low Back Pain: A Systematic Review , 2017, Journal of medical Internet research.

[22]  R. Ostelo,et al.  Multidisciplinary biopsychosocial rehabilitation for chronic low back pain. , 2014, The Cochrane database of systematic reviews.

[23]  J. Katz,et al.  Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. , 2006, The Journal of bone and joint surgery. American volume.

[24]  D. Weiner,et al.  A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial , 2016, Deutsche Zeitschrift für Akupunktur.

[25]  R. Osborne,et al.  Is regular use of physiotherapy treatment associated with health locus of control and self-management competency? A study of patients with musculoskeletal disorders undergoing physiotherapy in primary health care. , 2018, Musculoskeletal science & practice.

[26]  Peter Croft,et al.  Interpreting Change Scores for Pain and Functional Status in Low Back Pain: Towards International Consensus Regarding Minimal Important Change , 2008, Spine.

[27]  Roger Chou,et al.  Surgery for Low Back Pain: A Review of the Evidence for an American Pain Society Clinical Practice Guideline , 2009, Spine.

[28]  R. Shiri,et al.  Exercise for the Prevention of Low Back Pain: Systematic Review and Meta‐Analysis of Controlled Trials , 2018, American journal of epidemiology.

[29]  R Schwarzer,et al.  Social-cognitive predictors of health behavior: action self-efficacy and coping self-efficacy. , 2000, Health psychology : official journal of the Division of Health Psychology, American Psychological Association.

[30]  V. Chuter,et al.  Exercise interventions for the treatment of chronic low back pain: a systematic review and meta-analysis of randomised controlled trials , 2015, Clinical rehabilitation.

[31]  F. Griffiths,et al.  A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial. , 2010, Health technology assessment.

[32]  N. Manek,et al.  Epidemiology of back disorders: prevalence, risk factors, and prognosis , 2005, Current opinion in rheumatology.

[33]  T. Vos,et al.  Global, regional, and national incidence and prevalence, and years lived with disability for 328 diseases and injuries in 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016 , 2017 .

[34]  Timothy J Wilt,et al.  Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. , 2017, Annals of internal medicine.

[35]  C. Moravec,et al.  Biofeedback in medicine: who, when, why and how? , 2010, Mental health in family medicine.

[36]  A. Barnett,et al.  Evaluation of two time-specific back pain outcome measures. , 1999, Spine.

[37]  P. Pynsent,et al.  The Oswestry Disability Index. , 2000, Spine.

[38]  B. Koes,et al.  Low back pain. , 2002, American family physician.

[39]  G. Andersson.  Epidemiological features of chronic low-back pain , 1999, The Lancet.

[40]  D. Rubin.  Epidemiology and risk factors for spine pain. , 2007, Neurologic clinics.

[41]  Ricky Mullis,et al.  A primary care back pain screening tool: identifying patient subgroups for initial treatment. , 2008, Arthritis and rheumatism.