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Completed

NCT Number: NCT02647658

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Guideline Based Care plus Psychologically Informed Physical Therapy

Behavioral

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

Guideline Based Care (GBC)

Behavioral

Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives

Primary outcomes

  1. Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP)

    Time frame: 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.

  2. Functional Disability

    Time frame: 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 outcomes

  1. Number of Patients Referred to Physical Therapy

    Time frame: 12 months

    Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records over 12 months.

  2. Number of Patients Prescribed Opioids

    Time frame: 12 months

    Medication prescription for opioids measured using electronic health records over 12 months.

  3. Number of Patients With Orders for Diagnostic Imaging Tests

    Time frame: 12 months

    Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records

  4. Number of Patients Referred to Other Rehabilitation or Pain Management Specialist

    Time frame: 12 months

    Referral to any non-physical therapy rehabilitation or pain management specialist (chiropractic, physiatrist, pain management) measured using electronic health records

  5. Number of Patients Referred to Surgery Specialist

    Time frame: 12 months

    Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records

  6. Number of Patients Undergoing Interventional Pain Procedures

    Time frame: 12 months

    Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records

  7. Number of Patients Who Had Back Surgery

    Time frame: 12 months

    Documentation that patient underwent back surgery in electronic health records

Other outcomes

  1. Number of Patients Prescribed Opioids

    Time frame: Up to 21 days after initial visit for acute low back pain

    Medication prescription for opioids measured using electronic health records at the index baseline visit for the patient. Measure of intervention fidelity post clinic randomization.

  2. Number of Patients Referred to Physical Therapy

    Time frame: Up to 21 days after initial visit for acute low back pain

    Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records at the index baseline visit. This is a measure of intervention fidelity post-randomization of the clinics.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Boston Medical Center
  • Intermountain Health Care, Inc.
  • Johns Hopkins University
  • Medical University of South Carolina
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: TARGET

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 6, 2016
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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