Acute PainPhase 3PACBACKNCT03581123

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

A Phase 3 study testing Supported-Self Management (SSM), Spinal Manipulation Therapy (SMT) and SMT + SSM in people with Acute Pain and Low Back Pain, Mechanical, run by University of Minnesota at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Pain, Low Back Pain, Mechanical
What is being tested?: Supported-Self Management (SSM), Spinal Manipulation Therapy (SMT) and SMT + SSM
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,000 participants
Where: 3 sitesUnited States
Study dates: 1 Nov 2018to 12 Jun 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Acute Pain, Low Back Pain, Mechanical
Being tested: Supported-Self Management (SSM), Spinal Manipulation Therapy (SMT), SMT + SSM, Standard Medical Care (SMC)
Keywords: acute/subacute low back pain, randomized clinical trial, self-management, behavioral modification, spinal manipulation therapy, standard medical care, secondary prevention
Medical subject headings: Acute Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Supported-Self Management (SSM)Behavioural
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.
Spinal Manipulation Therapy (SMT)Other
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.
SMT + SSMCombination product
Combination Treatment
Standard Medical Care (SMC)Drug
Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.

Study groups in NCT03581123
Study group	Role	What they receive
Supported-Self management (SSM)	Experimental	Supported-Self management Receives: Behavioral: Supported-Self Management (SSM)
Spinal Manipulation Therapy (SMT)	Experimental	Spinal Manipulation Therapy Receives: Other: Spinal Manipulation Therapy (SMT)
SMT + SSM	Experimental	Spinal Manipulation Therapy + Supported Self-Management Receives: Combination Product: SMT + SSM
Standard Medical Care (SMC)	Active comparator	Standard Medical Care Receives: Drug: Standard Medical Care (SMC)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Average over months 10 -12

Secondary outcomes (30)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Months 1-12
Global Improvement
Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered )
Measured: 2 months
Global Improvement
Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered )
Measured: 6 months
Global Improvement
Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered )
Measured: 12 months
Patient Satisfaction With Treatment
Measured using a 7-point Likert scale: 0 (completely dissatisfied) to 6 (completely satisfied)
Measured: 2 months
Patient Satisfaction With Treatment
Measured using a 7-point Likert scale: 0 (completely dissatisfied) to 6 (completely satisfied)
Measured: 6 months
Patient Satisfaction With Treatment
Measured using a 7-point Likert scale: 0 (completely dissatisfied) to 6 (completely satisfied)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 2 months
Visual Trajectory for Pain
Assessed using 8 different diagrams describing back pain change over the last 12 months
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201812 Jun 2024

First posted10 Jul 2018
Study start1 Nov 2018
Primary completion12 Jun 2024
Study completion12 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Acute PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Model description: 2x2 factorial design
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 1,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03581123
Sponsor's protocol ID: CSH-2018-26524
Acronym: PACBACK
Status last verified: Sep 2025
First submitted: 3 May 2018
Last updated: 16 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Bronfort G, Meier EN, Leininger B, Schneider M, Evans R, Greco C, Hanson L, McFarland C, Chou R, Connett J, Delitto A, George SZ, Glick RM, Keefe F, Licciardone J, Schulz C, Turk D, Comstock BA, Vasconcelos AG, Heagerty PJ. Spinal Manipulation and Clinician-Supported Self-Management for Preventing Chronic Low Back Pain Impact: The PACBACK Randomized Clinical Trial. JAMA Intern Med. 2026 Jun 1:e261893. doi: 10.1001/jamainternmed.2026.1893. Online ahead of print.
PubMed 42223934
Bronfort G, Meier EN, Leininger B, Schneider M, Evans R, Greco C, Hanson L, McFarland C, Chou R, Connett J, Delitto A, George SZ, Glick RM, Keefe F, Licciardone J, Schulz C, Turk D, Heagerty PJ. Spinal Manipulation and Clinician-Supported Biopsychosocial Self-Management for Acute Back Pain: The PACBACK Randomized Clinical Trial. JAMA. 2026 Feb 10;335(6):497-510. doi: 10.1001/jama.2025.21990.
PubMed 41460638
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.
PubMed 37231386
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.
PubMed 37205428

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back
ClinicalTrials.gov ID: NCT03581123
Acronym / sponsor ID: PACBACK / CSH-2018-26524
Conditions: Acute Pain, Low Back Pain, Mechanical
Keywords: acute/subacute low back pain, randomized clinical trial, self-management, behavioral modification, spinal manipulation therapy, standard medical care, secondary prevention
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,000 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Collaborators: University of Pittsburgh, University of Washington, University of North Texas Health Science Center, Oregon Health and Science University, Duke University
Study start: 1 Nov 2018 (actual)
Primary completion: 12 Jun 2024 (actual)
Study completion: 12 Jun 2024 (actual)
First posted: 10 Jul 2018 (actual)
Results: Posted 16 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 4
Model description: 2x2 factorial design

Arm	Type	Receives
Supported-Self management (SSM)	Experimental	Behavioral: Supported-Self Management (SSM)Supported-Self management
Spinal Manipulation Therapy (SMT)	Experimental	Other: Spinal Manipulation Therapy (SMT)Spinal Manipulation Therapy
SMT + SSM	Experimental	Combination Product: SMT + SSMSpinal Manipulation Therapy + Supported Self-Management
Standard Medical Care (SMC)	Active comparator	Drug: Standard Medical Care (SMC)Standard Medical Care

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Supported-Self management (SSM)
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.	Other	Spinal Manipulation Therapy (SMT)
SMT + SSMCombination Treatment	Combination product	SMT + SSM
Standard Medical Care (SMC)Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.	Drug	Standard Medical Care (SMC)

Primary outcome

Pain Intensity
Time frame: Average over weeks 1-52
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.
Disability
Time frame: Average over months 1-12
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.
Low Back Pain (LBP) That is Impactful
Time frame: Average over 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). 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.

30 secondary outcomes

Recovery From Acute/Sub-acute Low Back Pain
Time frame: 6 months
Low Back Pain Frequency - Percent of Days Over 12 Months
Time frame: Weeks 1-52
Number of Participants Who Received Care For Low Back Pain
Time frame: Months 1-12
Medication Use - Percent of Months 4-12
Time frame: Months 4-12
Bothered by Low Back Pain at Work - Percent of Months
Time frame: Months 1-12
Global Improvement
Time frame: 2 months
Global Improvement
Time frame: 6 months
Global Improvement
Time frame: 12 months
Patient Satisfaction With Treatment
Time frame: 2 months
Patient Satisfaction With Treatment
Time frame: 6 months
Patient Satisfaction With Treatment
Time frame: 12 months
Chronic Low Back Pain (LBP)
Time frame: 6 months
Chronic Low Back Pain (LBP)
Time frame: 12 months
Number of Participants Who Reported Chronic Interference With Daily Activities
Time frame: 6 months
Number of Participants Who Reported Chronic Interference With Daily Activities
Time frame: 12 months
Timed Up and Go Test
Time frame: 2 months
Sit-to-stand
Time frame: 2 months
The Sock Test
Time frame: 2 months
Visual Trajectory for Pain
Time frame: 12 months
Quebec Task Force
Time frame: 2 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression
Time frame: Baseline and 2, 6, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Time frame: Baseline and 2, 6, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety
Time frame: Baseline and 2, 6, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue
Time frame: Baseline and 2, 6, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance
Time frame: Baseline and 2, 6, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Participation
Time frame: Baseline and 2, 6, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference
Time frame: Baseline and 2, 6, and 12 months
STarT Back Risk Classification
Time frame: 2 months
STarT Back Risk Classification
Time frame: 6 months
STarT Back Risk Classification
Time frame: 12 months

Results and safety

Results posted to the registry on 16 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Supported Self-Management (SSM)	305	305
Spinal Manipulation Therapy (SMT)	201	201
Combined SSM/SMT	193	193
Medical Care (MC)	301	301

Primary outcome: Pain Intensity

Time frame: Average over weeks 1-52. Mean (Standard Error). Unit: score on a scale

Measure	Supported Self-Management (SSM) n = 305	Spinal Manipulation Therapy (SMT) n = 201	Combined SSM/SMT n = 193	Medical Care (MC) n = 301
Value	2.8 (0.1)	3.0 (0.1)	2.8 (0.1)	3.0 (0.1)

Supported Self-Management (SSM) vs Spinal Manipulation Therapy (SMT) vs Combined SSM/SMT vs Medical Care (MC): p = 0.16, ANOVA
Supported Self-Management (SSM) vs Medical Care (MC): Mean Difference (Net): -0.2 (95% CI -0.5 to 0.0)
Spinal Manipulation Therapy (SMT) vs Medical Care (MC): Mean Difference (Net): 0.0 (95% CI -0.3 to 0.3)

Primary outcome: Disability

Time frame: Average over months 1-12. Mean (Standard Error). Unit: score on a scale

Measure	Supported Self-Management (SSM) n = 305	Spinal Manipulation Therapy (SMT) n = 201	Combined SSM/SMT n = 193	Medical Care (MC) n = 301
Value	4.7 (0.2)	5.5 (0.3)	4.8 (0.3)	5.9 (0.2)

Supported Self-Management (SSM) vs Spinal Manipulation Therapy (SMT) vs Combined SSM/SMT vs Medical Care (MC): p = 0.001, ANOVA
Supported Self-Management (SSM) vs Medical Care (MC): Mean Difference (Net): -1.2 (95% CI -1.9 to -0.5)
Spinal Manipulation Therapy (SMT) vs Medical Care (MC): Mean Difference (Net): -0.4 (95% CI -1.2 to 0.4)

Primary outcome: Low Back Pain (LBP) That is Impactful

Time frame: Average over months 10 -12. Mean (Standard Error). Unit: score on a scale

Measure	Supported Self-Management (SSM) n = 305	Spinal Manipulation Therapy (SMT) n = 201	Combined SSM/SMT n = 193	Medical Care (MC) n = 301
Value	15.3 (0.4)	16.7 (0.5)	15.7 (0.5)	17.0 (0.4)

Supported Self-Management (SSM) vs Spinal Manipulation Therapy (SMT) vs Combined SSM/SMT vs Medical Care (MC): p = 0.006, ANOVA
Supported Self-Management (SSM) vs Medical Care (MC): Mean Difference (Net): -1.7 (95% CI -2.7 to -0.6)
Spinal Manipulation Therapy (SMT) vs Medical Care (MC): Mean Difference (Net): -0.3 (95% CI -1.5 to 1.0)

30 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year from randomization. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Supported Self-Management (SSM)	27 of 298 (9.1%)	93 of 298 (31.2%)	0 of 298
Spinal Manipulation Therapy (SMT)	13 of 198 (6.6%)	63 of 198 (31.8%)	0 of 198
Combined SSM/SMT	22 of 190 (11.6%)	63 of 190 (33.2%)	0 of 190
Medical Care (MC)	22 of 296 (7.4%)	82 of 296 (27.7%)	0 of 296

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42223934Bronfort G, Meier EN, Leininger B, Schneider M, Evans R, Greco C, Hanson L, McFarland C, Chou R, Connett J, Delitto A, George SZ, Glick RM, Keefe F, Licciardone J, Schulz C, Turk D, Comstock BA, Vasconcelos AG, Heagerty PJ. Spinal Manipulation and Clinician-Supported Self-Management for Preventing Chronic Low Back Pain Impact: The PACBACK Randomized Clinical Trial. JAMA Intern Med. 2026 Jun 1:e261893. doi: 10.1001/jamainternmed.2026.1893. Online ahead of print.
Derived from this study: PubMed 41460638Bronfort G, Meier EN, Leininger B, Schneider M, Evans R, Greco C, Hanson L, McFarland C, Chou R, Connett J, Delitto A, George SZ, Glick RM, Keefe F, Licciardone J, Schulz C, Turk D, Heagerty PJ. Spinal Manipulation and Clinician-Supported Biopsychosocial Self-Management for Acute Back Pain: The PACBACK Randomized Clinical Trial. JAMA. 2026 Feb 10;335(6):497-510. doi: 10.1001/jama.2025.21990.
Derived from this study: PubMed 37231386Bronfort 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.
Derived from this study: PubMed 37205428Bronfort 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gert Bronfort, PhD, DC principal investigator

University of Minnesota

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (time frame: Average over weeks 1-52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03581123, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.