Evidence map›Paper›PMID 37231386›Full record

ArticleBMC musculoskeletal disorders2023

Effectiveness of spinal manipulation and biopsychosocial self-management compared to medical care for low back pain: a randomized trial study protocol.

Gert Bronfort, Anthony Delitto, Michael Schneider, Patrick J Heagerty, Roger Chou, John Connett, Roni Evans, Steven George, Ronald M Glick, Carol Greco and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC musculoskeletal disorders, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03581123 (Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03581123 phase3completednot on this map

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

TypeinterventionalSponsorUniversity of MinnesotaRan2018 to 2024Enrolled1,000ConditionsAcute Pain, Low Back Pain, MechanicalArmsSupported-Self Management (SSM), Spinal Manipulation Therapy (SMT), SMT + SSM, Standard Medical Care (SMC)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Trial
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 7 institutions in 1 country.

Gert BronfortIntegrative Health and Wellbeing Research Program Earl E. Bakken Center for Spirituality & Healing, University of Minnesota, Mayo Memorial Building C504, 420 Delaware Street, Minneapolis, MN, 55414, USA. bronf003@umn.edu.
Anthony DelittoSchool of Health and Rehabilitation Sciences, Department of Physical Therapy, University of Pittsburgh, 4029 Forbes Tower, Pittsburgh, PA, 15260, USA.
Michael SchneiderSchool of Health and Rehabilitation Sciences, Department of Physical Therapy, University of Pittsburgh, Bridgeside Point 1, 100 Technology Drive, Suite 500, Pittsburgh, PA, 15219, USA.
Patrick J HeagertySchool of Public Health, Department of Biostatistics, University of Washington, 1959 NE Pacific Street, Box 357232, Seattle, WA, 98195, USA.
Roger ChouSchool of Medicine, Division of General Internal Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road L475, Portland, OR, 97239-3098, USA.
John ConnettSchool of Public Health, Division of Biostatistics, University of Minnesota, 717 Delaware Street SE, 2nd Floor, Minneapolis, MN, 5455, USA.
Roni EvansIntegrative Health and Wellbeing Research Program Earl E. Bakken Center for Spirituality & Healing, University of Minnesota, Mayo Memorial Building C504, 420 Delaware Street, Minneapolis, MN, 55414, USA.
Steven GeorgeSchool of Medicine, Department of Orthopaedic Surgery, Duke University, 8020 North Pavilion, Durham, NC, 27705, USA.
Ronald M GlickSchool of Medicine, Departments of Psychiatry and Physical Medicine & Rehabilitation, University of Pittsburgh, 580 S. Aiken Avenue, Suite 310, Pittsburgh, PA, 15232, USA.
Carol GrecoSchool of Medicine, Department of Psychiatry, University of Pittsburgh, 580 S. Aiken Avenue, Suite 310, Pittsburgh, PA, 15232, USA.
Linda HansonIntegrative Health and Wellbeing Research Program Earl E. Bakken Center for Spirituality & Healing, University of Minnesota, Mayo Memorial Building C504, 420 Delaware Street, Minneapolis, MN, 55414, USA.
Francis KeefeSchool of Medicine, Department of Medicine, Duke University, 2200 W Main St., Suite 340, Durham, NC, 27705, USA.
Brent LeiningerIntegrative Health and Wellbeing Research Program Earl E. Bakken Center for Spirituality & Healing, University of Minnesota, Mayo Memorial Building C504, 420 Delaware Street, Minneapolis, MN, 55414, USA.
John LicciardoneHealth Science Center, University of North Texas, 3500 Camp Bowie Blvd, Fort Worth, TX, 76107, USA.
Christine McFarlandSchool of Health and Rehabilitation Sciences, Department of Physical Therapy, University of Pittsburgh, Bridgeside Point 1, 100 Technology Drive, Suite 500, Pittsburgh, PA, 15219, USA.
Eric MeierSchool of Public Health, Department of Biostatistics, University of Washington, 4333 Brooklyn Avenue NE, Box 359461, Seattle, WA, 98195, USA.
Craig SchulzIntegrative Health and Wellbeing Research Program Earl E. Bakken Center for Spirituality & Healing, University of Minnesota, Mayo Memorial Building C504, 420 Delaware Street, Minneapolis, MN, 55414, USA.
Dennis TurkDepartment of Anesthesiology & Pain Medicine, University of Washington, Box 358045, Seattle, WA, 98195, USA.
University of Minnesota · USUniversity of Pittsburgh · USUniversity of Washington · USDuke University · USBakken Museum · USOregon Health & Science University · USUniversity of North Texas Health Science Center · US

Funding

Transform Dissemination and Implementation Science in CTSA ProgramsUL1TR002319 · NCATS · UNIVERSITY OF WASHINGTON · PI John K. Amory · 2017 to 2026
$100.0M
Spinal Manipulation and Patient Self-Management to Prevent Back Pain ChronicityUH3AT008769 · NCCIH · UNIVERSITY OF MINNESOTA · PI BRONFORT, GERT · 2019 to 2023
$9.4M
Data Coordinating Center for Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain (PACBACK)UH3AT008767 · NCCIH · UNIVERSITY OF WASHINGTON · PI HEAGERTY, PATRICK J · 2019 to 2023
$2.0M
Clinical Coordinating Center for Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain (PACBACK)UG3AT008769 · NCCIH · UNIVERSITY OF MINNESOTA · PI BRONFORT, GERT, DELITTO, ANTHONY · 2017 to 2017
$1.9M
NCATS NIH HHS UL1 TR002319NCCIH NIH HHS UG3 AT008769NCCIH NIH HHS UG3AT008769 and UH3AT008769NCCIH NIH HHS UH3 AT008767NCCIH NIH HHS UH3 AT008769
6 · The paper itself

Abstract

backgroundChronic low back pain (cLBP) is widespread, costly, and burdensome to patients and health systems. Little is known about non-pharmacological treatments for the secondary prevention of cLBP. There is some evidence that treatments addressing psychosocial factors in higher risk patients are more effective than usual care. However, most clinical trials on acute and subacute LBP have evaluated interventions irrespective of prognosis.

methodsWe have designed a phase 3 randomized trial with a 2 × 2 factorial design. The study is also a Hybrid type 1 trial with focus on intervention effectiveness while simultaneously considering plausible implementation strategies. Adults (n = 1000) with acute/subacute LBP at moderate to high risk of chronicity based on the STarT Back screening tool will be randomized in to 1 of 4 interventions lasting up to 8 weeks: supported self-management (SSM), spinal manipulation therapy (SMT), both SSM and SMT, or medical care. The primary objective is to assess intervention effectiveness; the secondary objective is to assess barriers and facilitators impacting future implementation. Primary effectiveness outcome measures are: (1) average pain intensity over 12 months post-randomization (pain, numerical rating scale); (2) average low back disability over 12 months post-randomization (Roland-Morris Disability Questionnaire); (3) prevention of cLBP that is impactful at 10-12 months follow-up (LBP impact from the PROMIS-29 Profile v2.0). Secondary outcomes include: recovery, PROMIS-29 Profile v2.0 measures to assess pain interference, physical function, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities. Other patient-reported measures include LBP frequency, medication use, healthcare utilization, productivity loss, STarT Back screening tool status, patient satisfaction, prevention of chronicity, adverse events, and dissemination measures. Objective measures include the Quebec Task Force Classification, Timed Up & Go Test, the Sit to Stand Test, and the Sock Test assessed by clinicians blinded to the patients' intervention assignment. DISCUSSION: By targeting those subjects at higher risk this trial aims to fill an important gap in the scientific literature regarding the effectiveness of promising non-pharmacological treatments compared to medical care for the management of patients with an acute episode of LBP and the prevention of progression to a severe chronic back problem.

trial registrationClinicalTrials.gov Identifier: NCT03581123.

Indexed as

Low Back PainManipulation, SpinalSelf-ManagementAdultHumansPatient SatisfactionPrognosisRandomized Controlled Trials as TopicTreatment OutcomeLow back painMedical careSelf-managementSpinal manipulation

Identifiers

PMID37231386
PMCPMC10209583
OpenAlexW4378228599

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.