Suggestions in Hypnosis to Aid Pain Education (SHAPE) in People with Chronic Low-Back Pain: A Pilot Feasibility Randomized, Controlled Trial

ABSTRACT Chronic low back pain (CLBP) is a debilitating and burdensome condition, and new treatment strategies are needed. This study aimed to evaluate (1) the feasibility of undertaking a controlled clinical trial investigating a novel intervention for people with CLBP: hypnotically reinforced pain science education, and (2) the acceptability of the intervention as rated by participants. A priori feasibility and intervention acceptability criteria were set. Twenty participants with CLBP were recruited and randomized to receive: (1) hypnotically delivered pain science education that utilizes hypnotic suggestions to enhance uptake of pain science concepts; or (2) pain science education with progressive muscle relaxation as an attention control. Twenty participants were recruited, however, not solely from the hospital waitlist as intended; community sampling was required (13 hospital, 7 community). Most criteria were met in the community sample but not the hospital sample. Protocol modifications are needed before progressing to a full scale randomized controlled trial for hypnotically reinforced pain science education. Improvements in relevant secondary outcomes paired with moderate-high treatment acceptability ratings are promising.

[1]  Gilles E. Gignac,et al.  Clinical Hypnosis as an Adjunct to Cognitive Behavior Therapy: An Updated Meta-Analysis , 2021, The International journal of clinical and experimental hypnosis.

[2]  G. Moseley,et al.  What do patients value learning about pain? A mixed-methods survey on the relevance of target concepts after pain science education. , 2021, Pain.

[3]  Haniye Sadat Sajadi,et al.  Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017 , 2018, The Lancet.

[4]  M. Jensen,et al.  Hypnosis Enhances the Effects of Pain Education in Patients With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial. , 2018, The journal of pain : official journal of the American Pain Society.

[5]  E. Brooker.  Cognitive Hypnotherapy , 2018, Hypnotherapy and Hypnosis.

[6]  John C. Mohl.  Utilizing the Hypnotic Concomitants of Education: Suggestions to Enhance Teaching and Learning , 2018, The American journal of clinical hypnosis.

[7]  Emma Kirkpatrick,et al.  Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study , 2018, BMJ Open.

[8]  M. Jensen,et al.  Pain education for patients with non-specific low back pain in Nepal: protocol of a feasibility randomised clinical trial (PEN-LBP Trial) , 2018, BMJ Open.

[9]  R. Horton,et al.  Low back pain: a major global challenge , 2018, The Lancet.

[10]  Martin Underwood,et al.  Low back pain: a call for action , 2018, The Lancet.

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

[12]  S. Lamb,et al.  Reproducible and replicable pain research: a critical review. , 2018, Pain.

[13]  R. Chou.  Nonpharmacologic Therapies for Low Back Pain , 2017, Annals of Internal Medicine.

[14]  Josephine Louie,et al.  Book Review: Qualitative Research & Evaluation Methods: Integrating Theory and Practice (4th ed.) , 2017 .

[15]  R. Chou,et al.  Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline , 2017, Annals of Internal Medicine.

[16]  M. Campbell,et al.  CONSORT 2010 statement: extension to randomised pilot and feasibility trials , 2016, British Medical Journal.

[17]  P. Tugwell,et al.  CONSORT 2010 statement: extension to randomised pilot and feasibility trials , 2016, British Medical Journal.

[18]  I. Diener,et al.  The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature , 2016, Physiotherapy theory and practice.

[19]  G. Moseley,et al.  Does changing pain-related knowledge reduce pain and improve function through changes in catastrophizing? , 2016, Pain.

[20]  G. Moseley,et al.  Fifteen Years of Explaining Pain: The Past, Present, and Future. , 2015, The journal of pain : official journal of the American Pain Society.

[21]  Mickael Guedj,et al.  Analysis of drug combinations: current methodological landscape , 2015, Pharmacology research & perspectives.

[22]  M. Jensen,et al.  Brain Oscillations, Hypnosis, and Hypnotizability , 2015, The American journal of clinical hypnosis.

[23]  David Spiegel,et al.  Advancing Research and Practice: The Revised APA Division 30 Definition of Hypnosis , 2015, The International journal of clinical and experimental hypnosis.

[24]  Nathan E. Dodds,et al.  Validation of the depression item bank from the Patient-Reported Outcomes Measurement Information System (PROMIS) in a three-month observational study. , 2014, Journal of psychiatric research.

[25]  D. Nozaki,et al.  Hypnotic suggestion alters the state of the motor cortex , 2014, Neuroscience Research.

[26]  J. Abbott.  The distinction between randomized clinical trials (RCTs) and preliminary feasibility and pilot studies: what they are and are not. , 2014, The Journal of orthopaedic and sports physical therapy.

[27]  A. Vranceanu,et al.  Creation of the Abbreviated Measures of the Pain Catastrophizing Scale and the Short Health Anxiety Inventory: The PCS-4 and SHAI-5 , 2014 .

[28]  N. Wedderkopp,et al.  Absence of low back pain in the general population followed fortnightly over one year with automated text messages , 2014, Chiropractic & Manual Therapies.

[29]  Amanda J. Barnier,et al.  Developing the Sense of Agency Rating Scale (SOARS): An empirical measure of agency disruption in hypnosis , 2013, Consciousness and Cognition.

[30]  G. Moseley,et al.  How good is the neurophysiology of pain questionnaire? A Rasch analysis of psychometric properties. , 2013, The journal of pain : official journal of the American Pain Society.

[31]  David A. Oakley,et al.  Hypnotic suggestion: opportunities for cognitive neuroscience , 2013, Nature Reviews Neuroscience.

[32]  David M Walton,et al.  A Rasch Analysis of the Pain Catastrophizing Scale Supports its Use as an Interval-level Measure , 2013, The Clinical journal of pain.

[33]  Zoltan Dienes,et al.  Understanding hypnosis metacognitively: rTMS applied to left DLPFC increases hypnotic suggestibility , 2013, Cortex.

[34]  Sean Mackey,et al.  Development of the Stanford Expectations of Treatment Scale (SETS): A tool for measuring patient outcome expectancy in clinical trials , 2012, Clinical trials.

[35]  K. Refshauge,et al.  The Therapeutic Alliance Between Clinicians and Patients Predicts Outcome in Chronic Low Back Pain , 2012, Physical Therapy.

[36]  M. Pierrynowski,et al.  Fear and Avoidance of Movement in People with Chronic Pain: Psychometric Properties of the 11-Item Tampa Scale for Kinesiophobia (TSK-11). , 2012, Physiotherapy Canada. Physiotherapie Canada.

[37]  Daniel J Buysse,et al.  Development of Short Forms From the PROMIS™ Sleep Disturbance and Sleep-Related Impairment Item Banks , 2012, Behavioral sleep medicine.

[38]  David S Butler,et al.  The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. , 2011, Archives of physical medicine and rehabilitation.

[39]  R. Ardito,et al.  Therapeutic Alliance and Outcome of Psychotherapy: Historical Excursus, Measurements, and Prospects for Research , 2011, Front. Psychology.

[40]  Mark P. Jensen,et al.  Validity of four pain intensity rating scales , 2011, PAIN®.

[41]  S. Reise,et al.  Item Banks for Measuring Emotional Distress From the Patient-Reported Outcomes Measurement Information System (PROMIS®): Depression, Anxiety, and Anger , 2011, Assessment.

[42]  M. Jensen,et al.  Psychosocial approaches to pain management: An organizational framework , 2011, PAIN®.

[43]  I. Molton,et al.  Effects of Self-Hypnosis Training and Cognitive Restructuring on Daily Pain Intensity and Catastrophizing in Individuals With Multiple Sclerosis and Chronic Pain , 2010, The International journal of clinical and experimental hypnosis.

[44]  M. Campbell,et al.  What is a pilot or feasibility study? A review of current practice and editorial policy , 2010, BMC medical research methodology.

[45]  D. Amtmann,et al.  Development of a PROMIS item bank to measure pain interference , 2010, PAIN.

[46]  S. Vosniadou.  The Framework Theory Approach to the Problem of Conceptual Change , 2009 .

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

[48]  Douglas K Owens,et al.  Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain: An Evidence-Based Clinical Practice Guideline From the American Pain Society , 2009, Spine.

[49]  R. Deyo,et al.  Overtreating Chronic Back Pain: Time to Back Off? , 2009, The Journal of the American Board of Family Medicine.

[50]  Assen Alladin.  Cognitive Hypnotherapy: An Integrated Approach to the Treatment of Emotional Disorders , 2008 .

[51]  R. Deyo,et al.  Expenditures and health status among adults with back and neck problems. , 2008, JAMA.

[52]  R. Chou,et al.  Nonpharmacologic Therapies for Acute and Chronic Low Back Pain: A Review of the Evidence for an American Pain Society/American College of Physicians Clinical Practice Guideline , 2007, Annals of Internal Medicine.

[53]  David R. Patterson,et al.  Hypnotic Treatment of Chronic Pain , 2006, Journal of Behavioral Medicine.

[54]  Paul W. Hodges,et al.  A Randomized Controlled Trial of Intensive Neurophysiology Education in Chronic Low Back Pain , 2004, The Clinical journal of pain.

[55]  B. Walker,et al.  Low back pain in Australian adults: prevalence and associated disability. , 2004, Journal of manipulative and physiological therapeutics.

[56]  M. Jensen,et al.  One- and two-item measures of pain beliefs and coping strategies , 2003, Pain.

[57]  M. Yapko.  Hypnosis in Treating Symptoms and Risk Factors of Major Depression , 2001, The American journal of clinical hypnosis.

[58]  M. Roland,et al.  The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. , 2000, Spine.

[59]  M. Jensen,et al.  Pain belief assessment: A comparison of the short and long versions of the surgery of pain attitudes , 2000 .

[60]  I. Kirsch,et al.  Imaginative suggestibility and hypnotizability: an empirical analysis. , 1999, Journal of personality and social psychology.

[61]  Elliott H. Schreiber.  Use of Group Hypnosis to Improve College Students' Achievement , 1997, Psychological reports.

[62]  I. Kirsch,et al.  Hypnosis as an adjunct to cognitive-behavioral psychotherapy: a meta-analysis. , 1995, Journal of consulting and clinical psychology.

[63]  T. Barber,et al.  The creative imagination scale as a measure of hypnotic responsiveness: applications to experimental and clinical hypnosis. , 1978, The American journal of clinical hypnosis.