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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Behavioral: Guideline Based Care (GBC); Behavioral: Guideline Based Care plus Psychologically Informed Physical Therapy

• Registration Number: NCT02647658
• Lead Sponsor: University of Pittsburgh

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-06
• Study Start: 2016-03
• Primary Completion: 2019-03-01
• Study Completion: 2019-06-30
• Results First Submitted: 2019-12-10
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-04
• Last Update Submitted: 2020-02-04
• Results First Posted: 2020-02-10
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2300

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GBC	Guideline Based Care (GBC)	Guideline Based Care (GBC)
GBC+PIPT	Guideline Based Care plus Psychologically Informed Physical Therapy	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP)	6 months from baseline	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.
Functional Disability	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Referred to Surgery Specialist	12 months	Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records
Number of Patients Referred to Other Rehabilitation or Pain Management Specialist	12 months	Referral to any non-physical therapy rehabilitation or pain management specialist (chiropractic, physiatrist, pain management) measured using electronic health records
Number of Patients Prescribed Opioids	12 months	Medication prescription for opioids measured using electronic health records over 12 months.
Number of Patients With Orders for Diagnostic Imaging Tests	12 months	Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records
Number of Patients Who Had Back Surgery	12 months	Documentation that patient underwent back surgery in electronic health records
Number of Patients Referred to Physical Therapy	12 months	Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records over 12 months.
Number of Patients Undergoing Interventional Pain Procedures	12 months	Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records

Trial Locations

Locations (5)

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

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States