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

June 1, 2023 updated by: University of Minnesota

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

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gert Bronfort, PhD, DC
  • Phone Number: 612-626-6477
  • Email: bronf003@umn.edu

Study Contact Backup

  • Name: Linda M Hanson, DC, MS
  • Phone Number: 612-301-9009
  • Email: hans4236@umn.edu

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • University of Pittsburgh
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supported-Self management (SSM)
Supported-Self management
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
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 Treatment
Active Comparator: Standard Medical Care (SMC)
Standard Medical Care
Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average pain intensity over one year post-randomization
Time Frame: Weekly from enrollment - 52 weeks
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
Time Frame: Measured monthly from enrollment - 52 weeks
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
Time Frame: Months 10 -12
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
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.
Measured monthly from enrollment - 52 weeks
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.
Weekly from enrollment - 52 weeks
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.
Measured monthly from enrollment - 52 weeks
Healthcare Utilization
Time Frame: Measured monthly from enrollment - 52 weeks
Includes provider visits, emergency department visits, diagnostic imaging scans, hospitalizations, injections and surgical procedures.
Measured monthly from enrollment - 52 weeks
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.
Measured monthly from enrollment - 52 weeks
Risk factors for transitioning to chronic low back pain
Time Frame: Baseline, 2, 6, 12 months
Measured using the STarT Back Screening Tool.
Baseline, 2, 6, 12 months
Global Improvement
Time Frame: Baseline, 2, 6, 12 months
Measured using a 9-point scale (completely recovered to vastly worse)
Baseline, 2, 6, 12 months
Patient Satisfaction with Treatment
Time Frame: Baseline, 2, 6, 12 months
Measured using a 7-point Likert scale (completely satisfied to completely dissatisfied)
Baseline, 2, 6, 12 months
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.
Screening, baseline, 2, 6, 12 months
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.
Screening, baseline, 2, 6, 12 months
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
Screening, baseline, 2, 6, 12 months
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
Baseline, 1, 2 months
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) 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
Adverse Events
Time Frame: Measured during treatment and monthly from enrollment - 52 weeks
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
Chronic Interference with Daily Activities
Time Frame: Baseline, 6 and 12 months
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
Time Frame: Baseline, 12 months
Assessed using 8 different diagrams describing back pain change over the last 12 months
Baseline, 12 months
Healing Encounters and Attitudes Lists (HEAL)
Time Frame: Baseline, 2 weeks, and 1, 2, 6, 12 months
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
Prevention of chronic low back pain (LBP)
Time Frame: 6, 12 Months
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
Time Frame: Baseline and 2 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.
Baseline and 2 months
Sit-to-stand
Time Frame: Baseline and 2 months
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
Time Frame: Baseline and 2 months
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
Quebec Task Force
Time Frame: Baseline, 2 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.
Baseline, 2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. This is a psychosocial mediating measure.
Baseline, 2, 6, 12 months
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). This is a psychosocial mediating measure.
Baseline, 2, 6, 12 months
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). This is a psychosocial mediating measure.
Baseline, 2, 6, 12 months
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). This is a psychosocial mediating measure.
Baseline, 2, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gert Bronfort, PhD, DC, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Actual)

June 2, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain, Mechanical

Clinical Trials on Supported-Self Management (SSM)

3
Subscribe