Clinical trial NCT03581123: Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain
Official title: Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: University of Washington
name: University of North Texas Health Science Center
name: Oregon Health and Science University
name: Duke University
First posted: 2018-07-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial design
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Average pain intensity over one year post-randomization
timeFrame: Weekly from enrollment - 52 weeks
measure: Average disability over one year post-randomization
timeFrame: Measured monthly from enrollment - 52 weeks
measure: Prevention of chronic low back pain (LBP) that is impactful at 10-12 months follow-up
timeFrame: Months 10 -12
Secondary outcomes:
measure: Recovery from acute/sub-acute low back pain
timeFrame: 6 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: Measured monthly from enrollment - 52 weeks
measure: Low Back Pain Frequency
timeFrame: Weekly from enrollment - 52 weeks
measure: Healthcare Utilization
timeFrame: Measured monthly from enrollment - 52 weeks
measure: Medication Use
timeFrame: Measured monthly from enrollment - 52 weeks
measure: Productivity loss
timeFrame: Measured monthly from enrollment - 52 weeks
measure: Risk factors for transitioning to chronic low back pain
timeFrame: Baseline, 2, 6, 12 months
measure: Global Improvement
timeFrame: Baseline, 2, 6, 12 months
measure: Patient Satisfaction with Treatment
timeFrame: Baseline, 2, 6, 12 months
measure: Healing Encounters and Attitudes Lists (HEAL)
timeFrame: Baseline, 2 weeks, and 1, 2, 6, 12 months
measure: Intervention Barriers
timeFrame: Screening, baseline, 2, 6, 12 months
measure: Intervention Facilitators
timeFrame: Screening, baseline, 2, 6, 12 months
measure: Covid 19 Impact
timeFrame: Screening, baseline, 2, 6, 12 months
measure: Telehealth Usability Questionnaire
timeFrame: Baseline, 1, 2 months
measure: Adverse Events
timeFrame: Measured during treatment and monthly from enrollment - 52 weeks
measure: Prevention of chronic low back pain (LBP)
timeFrame: 6, 12 Months
measure: Timed Up and Go Test
timeFrame: Baseline and 2 months
measure: Sit-to-stand
timeFrame: Baseline and 2 months
measure: The Sock Test
timeFrame: Baseline and 2 months
measure: Chronic Interference with Daily Activities
timeFrame: Baseline, 6 and 12 months
measure: Visual Trajectory for Pain
timeFrame: Baseline, 12 months
measure: Quebec Task Force
timeFrame: Baseline, 2 months
Other outcomes:
measure: Self-efficacy
timeFrame: Baseline, 2, 6, 12 months
measure: Catastrophizing
timeFrame: Baseline, 2, 6, 12 months
measure: Kinesiophobia
timeFrame: Baseline, 2, 6, 12 months
measure: Coping
timeFrame: Baseline, 2, 6, 12 months
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Minnesota
name: Gert Bronfort, PhD, DC
role: PRINCIPAL_INVESTIGATOR
References: