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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back

Conditions
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Acute Pain, Low Back Pain, Mechanical

Intervention / Treatment
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* Behavioral: Supported-Self Management (SSM)
* Other: Spinal Manipulation Therapy (SMT)
* Combination Product: SMT + SSM
* Drug: Standard Medical Care (SMC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2x2 factorial design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supported-Self management (SSM)<br>Supported-Self management | Behavioral: Supported-Self Management (SSM)<br>* 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.<br>|
| Experimental: Spinal Manipulation Therapy (SMT)<br>Spinal Manipulation Therapy | Other: Spinal Manipulation Therapy (SMT)<br>* 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.<br>|
| Experimental: SMT + SSM<br>Spinal Manipulation Therapy + Supported Self-Management | Combination Product: SMT + SSM<br>* Combination Treatment<br>|
| Active Comparator: Standard Medical Care (SMC)<br>Standard Medical Care | Drug: Standard Medical Care (SMC)<br>* Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average pain intensity over one year post-randomization | Measured using the 0-10 numerical rating scale (0=no LBP, 10=the worst LBP possible). | Weekly from enrollment - 52 weeks | 
| Average disability over one year post-randomization | 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 monthly from enrollment - 52 weeks | 
| Prevention of chronic low back pain (LBP) that is impactful at 10-12 months follow-up | 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). | Months 10 -12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery from acute/sub-acute low back pain | 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. | 6 months | 
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Includes pain interference with normal activities, physical function, anxiety, depression, fatigue, sleep disturbance and the ability to participate in social roles and activities. | Measured monthly from enrollment - 52 weeks | 
| Low Back Pain Frequency | Participants report the number of days low back pain has been a problem in the past 7 days. | Weekly from enrollment - 52 weeks | 
| Healthcare Utilization | Includes provider visits, emergency department visits, diagnostic imaging scans, hospitalizations, injections and surgical procedures. | Measured monthly from enrollment - 52 weeks | 
| Medication Use | Over the counter and prescription medication use for low back pain including class and frequency by class. | Measured monthly from enrollment - 52 weeks | 
| Productivity loss | Missed work and reduced productivity while at work will be assessed using questions from the Institute for Medical Technology Assessment's productivity cost questionnaire. | Measured monthly from enrollment - 52 weeks | 
| Risk factors for transitioning to chronic low back pain | Measured using the STarT Back Screening Tool. | Baseline, 2, 6, 12 months | 
| Global Improvement | Measured using a 9-point scale (completely recovered to vastly worse) | Baseline, 2, 6, 12 months | 
| Patient Satisfaction with Treatment | Measured using a 7-point Likert scale (completely satisfied to completely dissatisfied) | Baseline, 2, 6, 12 months | 
| Healing Encounters and Attitudes Lists (HEAL) | 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) | Baseline, 2 weeks, and 1, 2, 6, 12 months | 
| Intervention Barriers | This qualitative assessment explores barriers to participation in the intervention using open ended questions in an electronic survey. | Screening, baseline, 2, 6, 12 months | 
| Intervention Facilitators | This qualitative assessment explores facilitators to participation in the intervention using open ended questions in an electronic survey. | Screening, baseline, 2, 6, 12 months | 
| Covid 19 Impact | Measured using the 7-item Pain Management Collaboratory (PMC) Coronavirus (COVID-19) Pandemic Measure | Screening, baseline, 2, 6, 12 months | 
| Telehealth Usability Questionnaire | Participants' views of the remote intervention delivery platform will be assessed using items adapted from the Telehealth Usability Questionnaire | Baseline, 1, 2 months | 
| Adverse Events | 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 during treatment and monthly from enrollment - 52 weeks | 
| Prevention of chronic low back pain (LBP) | 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). | 6, 12 Months | 
| Timed Up and Go Test | 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. | Baseline and 2 months | 
| Sit-to-stand | 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 | Baseline and 2 months | 
| The Sock Test | 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. | Baseline and 2 months | 
| Chronic Interference with Daily Activities | 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). | Baseline, 6 and 12 months | 
| Visual Trajectory for Pain | Assessed using 8 different diagrams describing back pain change over the last 12 months | Baseline, 12 months | 
| Quebec Task Force | 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. | Baseline, 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute/subacute low back pain, randomized clinical trial, self-management, behavioral modification, spinal manipulation therapy, standard medical care, secondary prevention