CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,000 enrolled
Drug / intervention
SMT + SSM +3 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03581123
NCT03581123Phase 3Completed
CompareCT.gov

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

University of Minnesota·interventional·Posted Jul 10, 2018·Updated Oct 16, 2025

In Brief

A Phase 3 clinical trial evaluating Supported-Self Management (SSM), Spinal Manipulation Therapy (SMT), and 2 other interventions for Acute Pain and Low Back Pain, Mechanical. Completed, enrolled 1,000 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain, Low Back Pain, Mechanical
CountriesUnited States
CollaboratorsUniversity of Pittsburgh, University of Washington, University of North Texas Health Science Center, Oregon Health and Science University, Duke University

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 10, 2018
Enrollment StartNov 1, 2018
Primary CompletionJun 12, 2024
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 8.0 years ago

Interventions

Supported-Self Management (SSM)behavioral

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

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.