Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 1,000
- Locations
- 3
- Primary Endpoint
- Pain Intensity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Supported-Self management (SSM)
Supported-Self management
Intervention: Supported-Self Management (SSM) (Behavioral)
Spinal Manipulation Therapy (SMT)
Spinal Manipulation Therapy
Intervention: Spinal Manipulation Therapy (SMT) (Other)
SMT + SSM
Spinal Manipulation Therapy + Supported Self-Management
Intervention: SMT + SSM (Combination Product)
Standard Medical Care (SMC)
Standard Medical Care
Intervention: Standard Medical Care (SMC) (Drug)
Outcomes
Primary Outcomes
Pain Intensity
Time Frame: 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.
Disability
Time Frame: 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.
Low Back Pain (LBP) That is Impactful
Time Frame: 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.
Secondary Outcomes
- Recovery From Acute/Sub-acute Low Back Pain(6 months)
- Low Back Pain Frequency - Percent of Days Over 12 Months(Weeks 1-52)
- Number of Participants Who Received Care For Low Back Pain(Months 1-12)
- Medication Use - Percent of Months 4-12(Months 4-12)
- Bothered by Low Back Pain at Work - Percent of Months(Months 1-12)
- Global Improvement(12 months)
- Patient Satisfaction With Treatment(12 months)
- Chronic Low Back Pain (LBP)(12 months)
- Number of Participants Who Reported Chronic Interference With Daily Activities(12 months)
- Timed Up and Go Test(2 months)
- Sit-to-stand(2 months)
- The Sock Test(2 months)
- Visual Trajectory for Pain(12 months)
- Quebec Task Force(2 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression(Baseline and 2, 6, and 12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function(Baseline and 2, 6, and 12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety(Baseline and 2, 6, and 12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue(Baseline and 2, 6, and 12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance(Baseline and 2, 6, and 12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Participation(Baseline and 2, 6, and 12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference(Baseline and 2, 6, and 12 months)
- STarT Back Risk Classification(12 months)