Phase 3
N=1,000
Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain
Acute Pain · Low Back Pain, Mechanical
Bottom Line
View on ClinicalTrials.gov: NCT03581123 ↗Enrolled (actual)
1,000
Serious AEs
8.6%
Results posted
Oct 2025
Primary outcome: Primary: Pain Intensity — 2.8; 3.0; 2.8; 3.0 score on a scale — p=0.16
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Supported-Self Management (SSM) (Behavioral); Spinal Manipulation Therapy (SMT) (Other); SMT + SSM (Combination_product); Standard Medical Care (SMC) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity |
2.8; 3.0; 2.8; 3.0 | 0.16 |
| PRIMARY Disability |
4.7; 5.5; 4.8; 5.9 | 0.001 sig |
| PRIMARY Low Back Pain (LBP) That is Impactful |
15.3; 16.7; 15.7; 17.0 | 0.006 sig |
| SECONDARY Recovery From Acute/Sub-acute Low Back Pain |
56; 29; 33; 38 | — |
| SECONDARY Low Back Pain Frequency - Percent of Days Over 12 Months |
39; 44; 38; 46 | — |
| SECONDARY Number of Participants Who Received Care For Low Back Pain |
82; 67; 53; 128 | — |
| SECONDARY Medication Use - Percent of Months 4-12 |
37; 40; 37; 54 | — |
| SECONDARY Bothered by Low Back Pain at Work - Percent of Months |
43; 45; 43; 51 | — |
| SECONDARY Global Improvement |
6.2; 5.8; 6.3; 5.5 | — |
| SECONDARY Global Improvement |
6.2; 5.8; 6.3; 5.5 | — |
| SECONDARY Global Improvement |
6.2; 5.8; 6.3; 5.5 | — |
| SECONDARY Patient Satisfaction With Treatment |
4.7; 4.6; 5.1; 4.0 | — |
| SECONDARY Patient Satisfaction With Treatment |
4.7; 4.6; 5.1; 4.0 | — |
| SECONDARY Patient Satisfaction With Treatment |
4.7; 4.6; 5.1; 4.0 | — |
| SECONDARY Chronic Low Back Pain (LBP) |
93; 93; 68; 151 | — |
| SECONDARY Chronic Low Back Pain (LBP) |
93; 93; 68; 151 | — |
| SECONDARY Number of Participants Who Reported Chronic Interference With Daily Activities |
41; 36; 36; 76 | — |
| SECONDARY Number of Participants Who Reported Chronic Interference With Daily Activities |
41; 36; 36; 76 | — |
| SECONDARY Timed Up and Go Test |
9.5; 9.5; 9.5; 10.0 | — |
| SECONDARY Sit-to-stand |
10.5; 11.4; 10.9; 10.9 | — |
| SECONDARY The Sock Test |
112; 65; 53; 114; 28; 15 | — |
| SECONDARY Visual Trajectory for Pain |
18; 6; 13; 15; 103; 53 | — |
| SECONDARY Quebec Task Force |
70; 38; 32; 59; 150; 106 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression |
50.6; 50.2; 50.8; 50.8; 49.6; 49.0 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function |
40.7; 21.7; 41.3; 40.5; 46.0; 46.8 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety |
53.5; 53.6; 54.2; 53.8; 51.7; 51.2 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue |
55.2; 54.3; 54.8; 55.2; 52.4; 51.2 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance |
52.0; 51.8; 52.0; 52.1; 52.6; 52.2 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) - Participation |
46.8; 47.7; 47.7; 46.6; 53.2; 53.5 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference |
60.3; 59.2; 59.9; 60.3; 52.9; 52.0 | — |
| SECONDARY STarT Back Risk Classification |
243; 158; 157; 226; 34; 23 | — |
| SECONDARY STarT Back Risk Classification |
243; 158; 157; 226; 34; 23 | — |
| SECONDARY STarT Back Risk Classification |
243; 158; 157; 226; 34; 23 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03581123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.