Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self-limited ("acute"), but some people can progress to a state of persistent pain. Often termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily activities, including job performance. This study will compare two approaches for preventing patients with acute LBP (aLBP) from developing cLBP using a pragmatic, cluster randomized trial. The first approach is to provide PCPs with information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage PCPs to treat patients according to accepted clinical guidelines. The second approach is to provide the same risk information and have PCPs team up with physical therapists to deliver psychologically-informed physical therapy (PIPT) for those patients determined to be at high risk for transitioning to cLBP. The 1,860 patients expected to be enrolled at five regional sites (Pittsburgh, Pennsylvania; Boston, Massachusetts; Baltimore, Maryland; Charleston, South Carolina; and Salt Lake City, Utah) will start the study when their LBP is in an acute phase. The study's primary aims are to compare the proportions of cLBP and measures of functional ability between the two groups at 6 months. Secondary aims are to measure the referrals to physical therapists and specialists, opioid prescriptions, LBP-related x-rays or MRIs, surgeries, and other medical procedures during a 12-month follow-up period.
Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self-limited ("acute"), but some people can progress to a state of persistent pain. Often termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily activities, including job performance. Most patients see chiropractors or primary care physicians (PCPs) for initial episodes of LBP. This study will compare two approaches for preventing patients with acute LBP (aLBP) from developing cLBP using a cluster randomized trial. Both treatments can be delivered in an outpatient PCP setting. The first approach is to provide PCPs with information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage PCPs to treat patients according to accepted clinical guidelines (Guideline Based Care, GBC). The second approach is to provide the same risk information and have PCPs team up with physical therapists to deliver psychologically-informed physical therapy (PIPT) for those patients determined to be at high risk for transitioning to cLBP (GBC+PIPT). PIPT is designed to help patients identify and overcome physical and psychological barriers to recovery. The 1,860 patients expected to be enrolled as part of quality improvement at five regional sites (Pittsburgh, Pennsylvania; Boston, Massachusetts; Baltimore, Maryland; Charleston, South Carolina; and Salt Lake City, Utah) will start the study when their LBP is in an acute phase. The study's primary aims are to compare the proportions of cLBP and measures of functional ability between the two groups at 6 months. Secondary aims are to measure the referrals to physical therapists and specialists, opioid prescriptions, LBP-related x-rays or MRIs, surgeries, and other medical procedures during a 12-month follow-up period. This study was designed with input from a variety of national and local stakeholders, including patients with LBP, providers, payers, professional organizations, purchasers, and policy representatives.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,300
PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
Johns Hopkins University
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Intermountain Healthcare
Salt Lake City, Utah, United States
Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP)
Measured using a 2-item Chronic Low Back Pain (LBP) questionnaire. Patient endorses low back pain that interferes with regular daily activities more than 3 months and more then 1/2 the days in the past 6 months.
Time frame: 6 months from baseline
Functional Disability
Measured using the 10-item Oswestry Disability Index (version 2.1a). Also known as the Oswestry Low Back Pain Disability Questionnaire. A measure of a patient's functional disability. The scale ranges from 0% to 100% with higher scores indicating more disability.
Time frame: 6 months
Number of Patients Referred to Physical Therapy
Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records over 12 months.
Time frame: 12 months
Number of Patients Prescribed Opioids
Medication prescription for opioids measured using electronic health records over 12 months.
Time frame: 12 months
Number of Patients With Orders for Diagnostic Imaging Tests
Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records
Time frame: 12 months
Number of Patients Referred to Other Rehabilitation or Pain Management Specialist
Referral to any non-physical therapy rehabilitation or pain management specialist (chiropractic, physiatrist, pain management) measured using electronic health records
Time frame: 12 months
Number of Patients Referred to Surgery Specialist
Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records
Time frame: 12 months
Number of Patients Undergoing Interventional Pain Procedures
Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records
Time frame: 12 months
Number of Patients Who Had Back Surgery
Documentation that patient underwent back surgery in electronic health records
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.