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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
Sponsor:
Collaborators:
University of Pittsburgh
University of Washington
University of North Texas Health Science Center
Oregon Health and Science University
Duke University
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1180 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2x2 factorial design
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Supported-Self management (SSM)
Supported-Self management
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
Combination Treatment

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.




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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).

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Healthcare Utilization [ Time Frame: Measured monthly from enrollment - 52 weeks ]
    Includes provider visits, emergency department visits, diagnostic imaging scans, hospitalizations, injections and surgical procedures.

  5. 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.

  6. Risk factors for transitioning to chronic low back pain [ Time Frame: Baseline, 2, 6, 12 months ]
    Measured using the STarT Back Screening Tool.

  7. 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.

  8. 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).

  9. 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).

  10. 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).

  11. Global Improvement [ Time Frame: Baseline, 2, 6, 12 months ]
    Measured using a 9-point scale (completely recovered to vastly worse)

  12. Patient Satisfaction with Treatment [ Time Frame: Baseline, 2, 6, 12 months ]
    Measured using a 7-point Likert scale (completely satisfied to completely dissatisfied)

  13. 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)

  14. 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.

  15. 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.

  16. 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

  17. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Gert Bronfort, PhD, DC 612-626-6477 bronf003@umn.edu
Contact: Linda M Hanson, DC, MS 612-301-9009 hans4236@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Linda M Hanson, DC, MS    612-626-6477    hans4236@umn.edu   
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    chrismcfarland@pitt.edu   
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
Sponsors and Collaborators
University of Minnesota
University of Pittsburgh
University of Washington
University of North Texas Health Science Center
Oregon Health and Science University
Duke University
Investigators
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Principal Investigator: Gert Bronfort, PhD, DC University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03581123    
Other Study ID Numbers: CSH-2018-26524
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
acute/subacute low back pain
randomized clinical trial
self-management
behavioral modification
spinal manipulation therapy
standard medical care
secondary prevention
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Acute Pain
Pain
Neurologic Manifestations