Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain (PACBACK)
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|ClinicalTrials.gov Identifier: NCT03581123|
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : July 15, 2022
The long-term objective is to reduce overall low back pain (LBP) burden by testing scalable, first-line, non-pharmacologic strategies that address the biopsychosocial aspects of acute/sub-acute LBP and prevent transition to chronic back pain.
The US is in the midst of an unprecedented pain management crisis. LBP is the most common chronic pain condition in adults and the leading cause of disability worldwide. Guidelines have recommended non-pharmacologic treatments like spinal manipulation and behavioral approaches for LBP for nearly a decade, yet uptake and adherence has been poor. Moreover, little is known about the role of these treatments in the secondary prevention of chronic LBP (cLBP), especially for patients with biopsychosocial risk factors. With burgeoning costs, mounting evidence of ineffectiveness, and harms of commonly used drug treatments, including opioids, there is a critical need for research on non-pharmacological treatments for cLBP prevention that can be readily translated to practice.
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain Low Back Pain, Mechanical||Behavioral: Supported-Self Management (SSM) Other: Spinal Manipulation Therapy (SMT) Combination Product: SMT + SSM Drug: Standard Medical Care (SMC)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1180 participants|
|Intervention Model:||Factorial Assignment|
|Intervention Model Description:||2x2 factorial design|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back|
|Actual Study Start Date :||October 25, 2018|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||September 2023|
Experimental: Supported-Self management (SSM)
Behavioral: Supported-Self Management (SSM)
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.
Experimental: Spinal Manipulation Therapy (SMT)
Spinal Manipulation Therapy
Other: Spinal Manipulation Therapy (SMT)
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.
Experimental: SMT + SSM
Spinal Manipulation Therapy + Supported Self-Management
Combination Product: SMT + SSM
Active Comparator: Standard Medical Care (SMC)
Standard Medical Care
Drug: Standard Medical Care (SMC)
Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
- Prevention of chronic low back pain (LBP) [ Time Frame: Months 10 -12 ]Measured by LBP Impact using the PROMIS-29 scale, ranging from 8 = least impact to 50 = greatest impact.
- Recovery from acute/sub-acute low back pain [ Time Frame: 6 months ]Measured by the proportion of patients with scores of 0 on the 0-10 pain numeric rating scale (NRS).
- Recovery from acute/sub-acute low back pain [ Time Frame: 6 months ]Measured by the proportion of patients with a LBP disability 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.
- Cumulative reduction of pain [ Time Frame: Weekly from enrollment - 52 weeks ]Measured using the 0-10 numerical rating scale (0=no LBP, 10=the worst LBP possible).
- Cumulative reduction of disability [ Time Frame: Measured monthly from enrollment - 52 weeks ]Measured using the RMDQ, a 24-item questionnaire that measures the degree to which a low back problem restricts daily activities.
- Patient-Reported Outcomes Measurement Information System (PROMIS-29) [ Time Frame: Measured monthly from enrollment - 52 weeks ]Includes pain interference with normal activities, physical function, anxiety, depression, fatigue, sleep disturbance and the ability to participate in social roles and activities.
- Low Back Pain Frequency [ Time Frame: Weekly from enrollment - 52 weeks ]Participants report the number of days low back pain has been a problem in the past 7 days.
- Medication Use [ Time Frame: Measured monthly from enrollment - 52 weeks ]Over the counter and prescription medication use for low back pain including class and frequency by class.
- Healthcare Utilization [ Time Frame: Measured monthly from enrollment - 52 weeks ]Includes provider visits, emergency department visits, diagnostic imaging scans, hospitalizations, injections and surgical procedures.
- Productivity loss [ Time Frame: Measured monthly from enrollment - 52 weeks ]Missed work and reduced productivity while at work will be assessed using questions from the Institute for Medical Technology Assessment's productivity cost questionnaire.
- Risk factors for transitioning to chronic low back pain [ Time Frame: Baseline, 2, 6, 12 months ]Measured using the STarT Back Screening Tool.
- Self-efficacy [ Time Frame: Baseline, 2, 6, 12 months ]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.
- Coping [ Time Frame: Baseline, 2, 6, 12 months ]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).
- Kinesiophobia [ Time Frame: Baseline, 2, 6, 12 months ]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).
- Catastrophizing [ Time Frame: Baseline, 2, 6, 12 months ]Measured using the 13-item Pain Catastrophizing Scale; it uses a 5-item point scale (0=not at all, 4 all the time).
- Global Improvement [ Time Frame: Baseline, 2, 6, 12 months ]Measured using a 9-point scale (completely recovered to vastly worse)
- Patient Satisfaction with Treatment [ Time Frame: Baseline, 2, 6, 12 months ]Measured using a 7-point Likert scale (completely satisfied to completely dissatisfied)
- Healing Encounters and Attitudes Lists (HEAL) [ Time Frame: Baseline, 2 weeks, and 1, 2, 6 months ]Includes patient-provider connection (7-item), healthcare environment (6-item), and treatment expectancy (6-item) from the HEAL measured on a 5-point scale (not at all to very much)
- Intervention Barriers [ Time Frame: Screening, baseline, 2, 6, 12 months ]This qualitative assessment explores barriers to participation in the intervention using open ended questions in an electronic survey.
- Intervention Facilitators [ Time Frame: Screening, baseline, 2, 6, 12 months ]This qualitative assessment explores facilitators to participation in the intervention using open ended questions in an electronic survey.
- Covid 19 Impact [ Time Frame: Screening, baseline, 2, 6, 12 months ]Measured using the 7-item Pain Management Collaboratory (PMC) Coronavirus (COVID-19) Pandemic Measure
- Telehealth Usability Questionnaire [ Time Frame: Baseline, 1, 2 months ]Participants' views of the remote intervention delivery platform will be assessed using items adapted from the Telehealth Usability Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581123
|Contact: Gert Bronfort, PhD, DCemail@example.com|
|Contact: Linda M Hanson, DC, MSfirstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Linda M Hanson, DC, MS 612-626-6477 email@example.com|
|Principal Investigator: Gert Bronfort, PhD, DC|
|Sub-Investigator: Brent Leininger, DC, MS|
|Sub-Investigator: Roni Evans, PhD, DC, MS|
|Sub-Investigator: Joyce Wahr, MD|
|Sub-Investigator: Craig Schulz, DC, MS|
|Sub-Investigator: John Connett, PhD, AM, AB|
|Sub-Investigator: Clarence Shannon, MD|
|Sub-Investigator: Linda Hanson, DC, MS|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15219|
|Contact: Christine "Chris" McFarland, BS 412-383-4323 firstname.lastname@example.org|
|Principal Investigator: Michael Schneider, PhD, DC|
|Principal Investigator: Anthony Delitto, PhD, PT|
|Sub-Investigator: Carol Greco, PhD|
|Sub-Investigator: Ronald Glick, MD|
|United States, Washington|
|University of Washington||Active, not recruiting|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Gert Bronfort, PhD, DC||University of Minnesota|