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

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

• Status: Completed
• Conditions: Low Back Pain, Mechanical; Acute Pain
• Intervention / Treatment: Behavioral: Supported-Self Management (SSM); Other: Spinal Manipulation Therapy (SMT); Combination product: SMT + SSM; Drug: Standard Medical Care (SMC)

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

Study Locations

• United States
  • 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

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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Measured using the 0-10 numerical rating scale (0=no LBP, 10=the worst LBP possible). Missing weekly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline pain intensity.	Average over weeks 1-52
Disability	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. Score ranges from 0 to 24 with higher values indicating more disability. Missing monthly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline RMDQ.	Average over months 1-12
Low Back Pain (LBP) That is Impactful	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). Missing monthly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline LBP impact score.	Average over 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
Low Back Pain Frequency - Percent of Days Over 12 Months	Participants report the number of days that low back pain has been a problem in the past 7 days for 52 weeks. This measure is the percent of days that low back pain has been a problem. Mean and confidence intervals are estimated using marginal standardization and bootstrapping. Adjustment for site, time period, and risk for chronicity.	Weeks 1-52
Number of Participants Who Received Care For Low Back Pain	Includes provider visits, emergency department visits, diagnostic imaging scans, hospitalizations, injections and surgical procedures. This is a binary indicator of any care from providers outside the study for low back pain.	Months 1-12
Medication Use - Percent of Months 4-12	Over the counter and prescription medication use for low back pain. Since the MC arm intervention includes medications, only months 4-12 (i.e. after the intervention) are considered for this outcome. The measure is the percent of months 4-12 in which medication was used for low back pain. Mean and confidence intervals are estimated using marginal standardization and bootstrapping. Adjustment for site, time period, and risk for chronicity.	Months 4-12
Bothered by Low Back Pain at Work - Percent of Months	Participants indicated in monthly follow-ups if they were bothered by low back pain over the last month. This measure is the percent of months that participants were bothered by low back pain at work. Mean and confidence intervals are estimated using marginal standardization and bootstrapping. Adjustment for site, time period, and risk for chronicity.	Months 1-12
Global Improvement	Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered )	2 months
Global Improvement	Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered )	6 months
Global Improvement	Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered )	12 months
Patient Satisfaction With Treatment	Measured using a 7-point Likert scale: 0 (completely dissatisfied) to 6 (completely satisfied)	2 months
Patient Satisfaction With Treatment	Measured using a 7-point Likert scale: 0 (completely dissatisfied) to 6 (completely satisfied)	6 months
Patient Satisfaction With Treatment	Measured using a 7-point Likert scale: 0 (completely dissatisfied) to 6 (completely satisfied)	12 months
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 months
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).	12 months
Number of Participants Who Reported 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). Here we dichotomize to "at least half the days in the past 6 months" or more.	6 months
Number of Participants Who Reported 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). Here we dichotomize to "at least half the days in the past 6 months" or more.	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.	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	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. Each leg is scored separately with the greater leg score serving as the overall score.	2 months
Visual Trajectory for Pain	Assessed using 8 different diagrams describing back pain change over the last 12 months	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.	2 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression	The PROMIS depression scale consists of 4 questions related to depression over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 41.0 - 79.3. Higher scores indicate greater depression. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.	Baseline and 2, 6, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function	The PROMIS physical function scale consists of 4 questions about ability to perform tasks of daily living. The raw score is converted to the T-Score that is reported here. The range of possible scores is 22.6 - 57.0. Higher scores indicate greater physical function. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.	Baseline and 2, 6, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety	The PROMIS anxiety scale consists of 4 questions related to anxiety over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 40.3 - 81.4. Higher scores indicate greater anxiety. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.	Baseline and 2, 6, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue	The PROMIS fatigue scale consists of 4 questions related to fatigue over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 33.7 - 75.8. Higher scores indicate greater fatigue. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.	Baseline and 2, 6, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance	The PROMIS sleep disturbance scale consists of 4 questions related to sleep disturbance over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 32.0 - 73.3. Higher scores indicate greater sleep disturbance. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.	Baseline and 2, 6, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Participation	The PROMIS participation scale consists of 4 questions related to participation in social activities. The raw score is converted to the T-Score that is reported here. The range of possible scores is 27.5 - 64.2. Higher scores indicate greater ability to participate in social activities. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.	Baseline and 2, 6, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference	The PROMIS participation scale consists of 4 questions related to pain interference in the last 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 41.6 - 75.6. Higher scores indicate greater pain interference. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation.	Baseline and 2, 6, and 12 months
STarT Back Risk Classification	The STarT Back Screening Tool is a 9-item questionnaire used to identify prognostic risk factors in patients with low back pain. It assesses physical and psychosocial factors, including referred pain, disability, fear-avoidance, anxiety, and depression. Scores are totaled (0-9) and a psychosocial subscale score (items 5-9, range 0-5) is calculated. Patients are classified as: low risk (total ≤3), medium risk (total ≥4 and psychosocial subscale ≤3), or high risk (total ≥4 and psychosocial subscale ≥4).	2 months
STarT Back Risk Classification	The STarT Back Screening Tool is a 9-item questionnaire used to identify prognostic risk factors in patients with low back pain. It assesses physical and psychosocial factors, including referred pain, disability, fear-avoidance, anxiety, and depression. Scores are totaled (0-9) and a psychosocial subscale score (items 5-9, range 0-5) is calculated. Patients are classified as: low risk (total ≤3), medium risk (total ≥4 and psychosocial subscale ≤3), or high risk (total ≥4 and psychosocial subscale ≥4).	6 months
STarT Back Risk Classification	The STarT Back Screening Tool is a 9-item questionnaire used to identify prognostic risk factors in patients with low back pain. It assesses physical and psychosocial factors, including referred pain, disability, fear-avoidance, anxiety, and depression. Scores are totaled (0-9) and a psychosocial subscale score (items 5-9, range 0-5) is calculated. Patients are classified as: low risk (total ≤3), medium risk (total ≥4 and psychosocial subscale ≤3), or high risk (total ≥4 and psychosocial subscale ≥4).	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy	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	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	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	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

• Sponsor: University of Minnesota
• Collaborators: University of Pittsburgh; Duke University; Oregon Health and Science University; University of Washington; University of North Texas Health Science Center
• Investigators: Principal Investigator: Gert Bronfort, PhD, DC, University of Minnesota

Publications and helpful links

General Publications

• Bronfort G, Delitto A, Schneider M, Heagerty PJ, Chou R, Connett J, Evans R, George S, Glick RM, Greco C, Hanson L, Keefe F, Leininger B, Licciardone J, McFarland C, Meier E, Schulz C, Turk D. Effectiveness of spinal manipulation and biopsychosocial self-management compared to medical care for low back pain: a randomized trial study protocol. BMC Musculoskelet Disord. 2023 May 25;24(1):415. doi: 10.1186/s12891-023-06549-w.
• Bronfort G, Delitto A, Schneider M, Heagerty P, Chou R, Connett J, Evans R, George S, Glick R, Greco C, Hanson L, Keefe F, Leininger B, Licciardone J, McFarland C, Meier E, Schulz C, Turk D. Effectiveness of Spinal Manipulation and Biopsychosocial Self-Management compared to Medical Care for Low Back Pain: A Randomized Trial Study Protocol. Res Sq [Preprint]. 2023 May 3:rs.3.rs-2865633. doi: 10.21203/rs.3.rs-2865633/v1.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): June 12, 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 (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: self-management; behavioral modification; randomized clinical trial; secondary prevention; spinal manipulation therapy; acute/subacute low back pain; standard medical care
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Acute Pain; Low Back Pain; specific substance maruyama
• Other Study ID Numbers: CSH-2018-26524

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No