Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain (PACBACK)

University of Pittsburgh, University of Washington, University of North Texas Health Science Center, Oregon Health and Science University, Duke University

This is a study of adults with acute low back pain flare-up at risk of becoming chronic and disabling. The study tests how well spinal manipulation and guided selfcare work compared to standard medical care. The treatments last up to eight weeks and participants will be followed for one year.

The long-term goal is to reduce overall low back pain (LBP) burden by evaluating, first-line, non-drug treatment strategies that address the biological, psychological and social aspects of acute LBP and prevent transition to chronic back pain. The study will also assess barriers and facilitators that impact future implementation of the non-drug treatments into clinical practice. The US faces an unprecedented pain management crisis. LBP is the most common chronic pain condition in adults and one of the leading causes of disability worldwide. Guidelines have recommended non-drug treatments like spinal manipulation and behavioral and selfcare approaches for LBP for nearly a decade, yet uptake and adherence has been poor. Little is known about the role of these treatments in the secondary prevention of chronic LBP, especially for patients at risk of developing severe low back pain. Due to high societal costs, and side effects of commonly used drug treatments, including opioids, there is a critical need for research on how well non-drug treatments work for preventing serious chronic LBP.

acute/subacute low back pain, randomized clinical trial, self-management, behavioral modification, spinal manipulation therapy, standard medical care, secondary prevention

Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.

SMT will address the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.

Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.

Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that measures the degree to which a low back problem restricts daily activities.

Measured by the LBP impact scale which includes measures of pain intensity, pain interference, and physical function from the PROMIS-29 Profile v2.0. The scale ranges from 8 (least impact) to 50 (greatest impact).

Measured by the proportion of patients with scores of 0 on the 0-10 pain numeric rating scale (NRS) and a score of less than or equal to 2 on the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that measures the degree to which a low back problem restricts daily activities.

Includes pain interference with normal activities, physical function, anxiety, depression, fatigue, sleep disturbance and the ability to participate in social roles and activities.

Includes provider visits, emergency department visits, diagnostic imaging scans, hospitalizations, injections and surgical procedures.

Over the counter and prescription medication use for low back pain including class and frequency by class.

Missed work and reduced productivity while at work will be assessed using questions from the Institute for Medical Technology Assessment's productivity cost questionnaire.

Includes patient-provider connection (7-item), healthcare environment (6-item), positive outlook (6-item) and treatment expectancy (6-item) from the HEAL measured on a 5-point scale (not at all to very much)

This qualitative assessment explores barriers to participation in the intervention using open ended questions in an electronic survey.

This qualitative assessment explores facilitators to participation in the intervention using open ended questions in an electronic survey.

Measured using the 7-item Pain Management Collaboratory (PMC) Coronavirus (COVID-19) Pandemic Measure

Participants' views of the remote intervention delivery platform will be assessed using items adapted from the Telehealth Usability Questionnaire

Any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline, appears to worsen.

Measured by the proportion of patients in each group meeting the definition by the NIH Task Force on Research Standards for Chronic LBP (i.e., ongoing LBP on ≥50% of days over past 6 months).

Measured by a blinded examiner, in seconds, the time taken by a person to stand up, walk a distance of 10 feet, turn, walk back to the chair and sit down again.

Measured by a blinded examiner, in seconds, the amount of time a person requires to stand up and sit down from a chair 5 times without using their arms

Measured by a blinded examiner on a scale from 0-3, with 0 being can easily grab the toes with the fingertips of both hands and 3 being can hardly, if at all, reach as far as to the malleoli.

Assessed using "how often has low back pain interfered with your ability to do regular activities over the past 6 months?" on a 3-item scale (less than half the days in the past 6 months, at least half the days in the past 6 months, every day or nearly every day in the past 6 months).

Measured by a blinded examiner who will classify the participant's spinal disorder as 0) no pain; 1) pain without radiation; 2) pain with radiation to the proximal extremity; 3) pain with radiation to the distal extremity; 4) pain with radiation to the extremity and neurologic signs.

Using a 10-100 numerical rating scale (10=very uncertain, 100 = very certain), self-efficacy is measured with the 22-item Chronic Pain Self-Efficacy Scale adapted for acute/sub-acute pain. This is a psychosocial mediating measure.

Measured using the 13-item Pain Catastrophizing Scale; it uses a 5-item point scale (0=not at all, 4 all the time). This is a psychosocial mediating measure.

Measured using the 11-item Tampa Scale for Kinesiophobia demonstrated to have internal consistency, responsiveness and validity similar to the original 17-item instrument. A four-item scale is used (strongly disagree to strongly agree). This is a psychosocial mediating measure.

Measured using an adapted version of the 28-item Brief Coping Orientation to Problems Experienced (COPE) instrument on a 4 point scale (I haven't been doing this at all to I've been doing this a lot). This is a psychosocial mediating measure.

Inclusion Criteria: At least 18 years of age Acute or sub-acute low back pain Average low back pain severity ≥3 on the 0-10 numerical rating scale over 7 days Medium or high risk for persistent disabling back pain according to the STarT Back screening tool Ability to read and write fluently in English Exclusion Criteria: Non-mechanical causes of low back pain Contraindications to study treatments (e.g,. surgical fusion of lumbar spine) Active management of current episode of low back pain by another healthcare provider Serious co-morbid health condition that either requires medical attention or has a risk for general health decline over the next year Pregnancy, current or planned during study period and nursing mothers Inability or unwillingness to give written informed consent