- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03581123
Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain (PACBACK)
Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
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
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15219
- University of Pittsburgh
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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Experimental: Spinal Manipulation Therapy (SMT)
Spinal Manipulation Therapy
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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
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Combination Treatment
|
Active Comparator: Standard Medical Care (SMC)
Standard Medical Care
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Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
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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).
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Weekly from enrollment - 52 weeks
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Average disability over one year post-randomization
Time Frame: Measured monthly from enrollment - 52 weeks
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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
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Prevention of chronic low back pain (LBP) that is impactful at 10-12 months follow-up
Time Frame: Months 10 -12
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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).
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Months 10 -12
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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.
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Measured monthly from enrollment - 52 weeks
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Low Back Pain Frequency
Time Frame: Weekly from enrollment - 52 weeks
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Participants report the number of days low back pain has been a problem in the past 7 days.
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Weekly from enrollment - 52 weeks
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Medication Use
Time Frame: Measured monthly from enrollment - 52 weeks
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Over the counter and prescription medication use for low back pain including class and frequency by class.
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Measured monthly from enrollment - 52 weeks
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Healthcare Utilization
Time Frame: Measured monthly from enrollment - 52 weeks
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Includes provider visits, emergency department visits, diagnostic imaging scans, hospitalizations, injections and surgical procedures.
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Measured monthly from enrollment - 52 weeks
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Productivity loss
Time Frame: Measured monthly from enrollment - 52 weeks
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Missed work and reduced productivity while at work will be assessed using questions from the Institute for Medical Technology Assessment's productivity cost questionnaire.
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Measured monthly from enrollment - 52 weeks
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Risk factors for transitioning to chronic low back pain
Time Frame: Baseline, 2, 6, 12 months
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Measured using the STarT Back Screening Tool.
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Baseline, 2, 6, 12 months
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Global Improvement
Time Frame: Baseline, 2, 6, 12 months
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Measured using a 9-point scale (completely recovered to vastly worse)
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Baseline, 2, 6, 12 months
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Patient Satisfaction with Treatment
Time Frame: Baseline, 2, 6, 12 months
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Measured using a 7-point Likert scale (completely satisfied to completely dissatisfied)
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Baseline, 2, 6, 12 months
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Intervention Barriers
Time Frame: Screening, baseline, 2, 6, 12 months
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This qualitative assessment explores barriers to participation in the intervention using open ended questions in an electronic survey.
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Screening, baseline, 2, 6, 12 months
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Intervention Facilitators
Time Frame: Screening, baseline, 2, 6, 12 months
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This qualitative assessment explores facilitators to participation in the intervention using open ended questions in an electronic survey.
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Screening, baseline, 2, 6, 12 months
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Covid 19 Impact
Time Frame: Screening, baseline, 2, 6, 12 months
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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
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Participants' views of the remote intervention delivery platform will be assessed using items adapted from the Telehealth Usability Questionnaire
|
Baseline, 1, 2 months
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Recovery from acute/sub-acute low back pain
Time Frame: 6 months
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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.
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6 months
|
Adverse Events
Time Frame: Measured during treatment and monthly from enrollment - 52 weeks
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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.
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Measured during treatment and monthly from enrollment - 52 weeks
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Chronic Interference with Daily Activities
Time Frame: Baseline, 6 and 12 months
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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).
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Baseline, 6 and 12 months
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Visual Trajectory for Pain
Time Frame: Baseline, 12 months
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Assessed using 8 different diagrams describing back pain change over the last 12 months
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Baseline, 12 months
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Healing Encounters and Attitudes Lists (HEAL)
Time Frame: Baseline, 2 weeks, and 1, 2, 6, 12 months
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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)
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Baseline, 2 weeks, and 1, 2, 6, 12 months
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Prevention of chronic low back pain (LBP)
Time Frame: 6, 12 Months
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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).
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6, 12 Months
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Timed Up and Go Test
Time Frame: Baseline and 2 months
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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.
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Baseline and 2 months
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Sit-to-stand
Time Frame: Baseline and 2 months
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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
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Baseline and 2 months
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The Sock Test
Time Frame: Baseline and 2 months
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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
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Quebec Task Force
Time Frame: Baseline, 2 months
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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.
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Baseline, 2 months
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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.
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Baseline, 2, 6, 12 months
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Catastrophizing
Time Frame: Baseline, 2, 6, 12 months
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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.
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Baseline, 2, 6, 12 months
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Kinesiophobia
Time Frame: Baseline, 2, 6, 12 months
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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.
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Baseline, 2, 6, 12 months
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Coping
Time Frame: Baseline, 2, 6, 12 months
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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.
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Baseline, 2, 6, 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gert Bronfort, PhD, DC, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSH-2018-26524
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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