Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic Cluster Randomized Controlled Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: Guideline Based Care plus Psychologically Informed Physical Therapy
* Behavioral: Guideline Based Care (GBC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Receiving care for acute low back pain during a primary care clinic visit Able to provide informed consent Exclusion Criteria: Medical contraindications to physical therapy based on the judgment of the primary care provider as documented in the medical record (i.e., red flag signs and symptoms of a potentially serious condition such as cauda equina syndrome, major or rapidly progressing neurological deficit, cancer, spinal infection or fracture)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment of clusters (clinics). Cluster randomized trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GBC+PIPT<br>Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) | Behavioral: Guideline Based Care plus Psychologically Informed Physical Therapy<br>* 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<br>|
| Active Comparator: GBC<br>Guideline Based Care (GBC) | Behavioral: Guideline Based Care (GBC)<br>* Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| Number of Patients Prescribed Opioids | Medication prescription for opioids measured using electronic health records over 12 months. | 12 months | 
| Number of Patients With Orders for Diagnostic Imaging Tests | Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records | 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 | 12 months | 
| Number of Patients Referred to Surgery Specialist | Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records | 12 months | 
| Number of Patients Undergoing Interventional Pain Procedures | Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records | 12 months | 
| Number of Patients Who Had Back Surgery | Documentation that patient underwent back surgery in electronic health records | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute low back pain, primary care, psychologically informed physical therapy, cluster randomized pragmatic trial, comparative effectiveness, secondary prevention