18 and older, any sex, with Acute Pain or Low Back Pain, Mechanical. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pain IntensityPrimary· 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.
Group
Value
95% CI
Supported Self-Management (SSM)
2.8
± 0.1
Spinal Manipulation Therapy (SMT)
3.0
± 0.1
Combined SSM/SMT
2.8
± 0.1
Medical Care (MC)
3.0
± 0.1
DisabilityPrimary· 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.
Group
Value
95% CI
Supported Self-Management (SSM)
4.7
± 0.2
Spinal Manipulation Therapy (SMT)
5.5
± 0.3
Combined SSM/SMT
4.8
± 0.3
Medical Care (MC)
5.9
± 0.2
Low Back Pain (LBP) That is ImpactfulPrimary· 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.
Group
Value
95% CI
Supported Self-Management (SSM)
15.3
± 0.4
Spinal Manipulation Therapy (SMT)
16.7
± 0.5
Combined SSM/SMT
15.7
± 0.5
Medical Care (MC)
17.0
± 0.4
Recovery From Acute/Sub-acute Low Back PainSecondary· 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.
Group
Value
95% CI
Supported Self-Management (SSM)
56
Spinal Manipulation Therapy (SMT)
29
Combined SSM/SMT
33
Medical Care (MC)
38
Low Back Pain Frequency - Percent of Days Over 12 MonthsSecondary· Weeks 1-52
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.
Group
Value
95% CI
Supported Self-Management (SSM)
39
36 – 43
Spinal Manipulation Therapy (SMT)
44
40 – 48
Combined SSM/SMT
38
34 – 42
Medical Care (MC)
46
42 – 49
Number of Participants Who Received Care For Low Back PainSecondary· Months 1-12
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.
Group
Value
95% CI
Supported Self-Management (SSM)
82
Spinal Manipulation Therapy (SMT)
67
Combined SSM/SMT
53
Medical Care (MC)
128
Medication Use - Percent of Months 4-12Secondary· 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.
Group
Value
95% CI
Supported Self-Management (SSM)
37
33 – 42
Spinal Manipulation Therapy (SMT)
40
34 – 46
Combined SSM/SMT
37
31 – 43
Medical Care (MC)
54
50 – 58
Bothered by Low Back Pain at Work - Percent of MonthsSecondary· Months 1-12
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.
Group
Value
95% CI
Supported Self-Management (SSM)
43
39 – 47
Spinal Manipulation Therapy (SMT)
45
40 – 51
Combined SSM/SMT
43
38 – 48
Medical Care (MC)
51
47 – 55
Global ImprovementSecondary· 2 months
Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered )
Group
Value
95% CI
Supported Self-Management (SSM)
6.2
± 1.2
Spinal Manipulation Therapy (SMT)
6.3
± 1.0
Combined SSM/SMT
6.4
± 1.1
Medical Care (MC)
5.7
± 1.5
Global ImprovementSecondary· 6 months
Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered )
Group
Value
95% CI
Supported Self-Management (SSM)
6.1
± 1.4
Spinal Manipulation Therapy (SMT)
6.0
± 1.3
Combined SSM/SMT
6.3
± 1.4
Medical Care (MC)
5.5
± 1.7
Global ImprovementSecondary· 12 months
Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered )
Group
Value
95% CI
Supported Self-Management (SSM)
6.2
± 1.3
Spinal Manipulation Therapy (SMT)
5.8
± 1.6
Combined SSM/SMT
6.3
± 1.4
Medical Care (MC)
5.5
± 1.6
Patient Satisfaction With TreatmentSecondary· 2 months
Measured using a 7-point Likert scale: 0 (completely dissatisfied) to 6 (completely satisfied)
Group
Value
95% CI
Supported Self-Management (SSM)
4.9
± 1.0
Spinal Manipulation Therapy (SMT)
5.0
± 0.9
Combined SSM/SMT
5.2
± 0.9
Medical Care (MC)
4.2
± 1.3
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year from randomization.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Supported Self-Management (SSM)
Serious: 27/298 (9%)
Deaths: 0/298
Spinal Manipulation Therapy (SMT)
Serious: 13/198 (7%)
Deaths: 0/198
Combined SSM/SMT
Serious: 22/190 (12%)
Deaths: 0/190
Medical Care (MC)
Serious: 22/296 (7%)
Deaths: 0/296
Serious adverse events (28 terms)
Reaction
System
Supported Self-Management …
Spinal Manipulation Therap…
Combined SSM/SMT
Medical Care (MC)
Other surgical/medical procedure
Surgical and medical procedures
—
—
—
—
Cardiac problems
Cardiac disorders
—
—
—
—
Gastrointestinal issues
Gastrointestinal disorders
—
—
—
—
Lumbar back-related procedure
Surgical and medical procedures
—
—
—
—
Fall or accident
Injury, poisoning and procedural complications
—
—
—
—
Nervous system problem
Nervous system disorders
—
—
—
—
Non-COVID infection
Infections and infestations
—
—
—
—
Diabetes complications
Endocrine disorders
—
—
—
—
Respiratory issue
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
—
—
COVID
Infections and infestations
—
—
—
—
Suicidal ideation
Psychiatric disorders
—
—
—
—
Substance abuse
Psychiatric disorders
—
—
—
—
Inpatient mental health visit
Psychiatric disorders
—
—
—
—
Nephrolithiasis
Renal and urinary disorders
—
—
—
—
Cancers
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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· NA
· recruiting
NCT07335159 — Does Patient Testimonial Improve the Pain Relief Derived From a Brief Intervention
· NA
· recruiting
NCT07348523 — Comparison of the Postoperative Analgesic Efficacy of Classical and Modified Erector Spinae Plane Blocks After Lumbar Sp
· NA
· recruiting
NCT07336264 — Characterization of Acute Pain
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Minnesota
Last refreshed: 16 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03581123.