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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02647658
Recruitment Status : Completed
First Posted : January 6, 2016
Results First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Collaborators:
Boston Medical Center
Intermountain Health Care, Inc.
Johns Hopkins University
Medical University of South Carolina
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Anthony Delitto, 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Behavioral: Guideline Based Care plus Psychologically Informed Physical Therapy Behavioral: Guideline Based Care (GBC) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment of clusters (clinics). Cluster randomized trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic Cluster Randomized Controlled Trial
Study Start Date : March 2016
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: GBC+PIPT
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Behavioral: Guideline Based Care plus Psychologically Informed Physical Therapy
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

Active Comparator: GBC
Guideline Based Care (GBC)
Behavioral: Guideline Based Care (GBC)
Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647658


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Utah
Intermountain Healthcare
Salt Lake City, Utah, United States, 84111
Sponsors and Collaborators
University of Pittsburgh
Boston Medical Center
Intermountain Health Care, Inc.
Johns Hopkins University
Medical University of South Carolina
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Anthony Delitto, PT, PhD University of Pittsburgh
Principal Investigator: Robert Saper, MD, MPH Boston Medical Center
  Study Documents (Full-Text)

Documents provided by Anthony Delitto, University of Pittsburgh:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anthony Delitto, Professor and Dean, SHRS, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02647658    
Other Study ID Numbers: PCS-1402-10867
First Posted: January 6, 2016    Key Record Dates
Results First Posted: February 10, 2020
Last Update Posted: February 10, 2020
Last Verified: February 2020
Keywords provided by Anthony Delitto, University of Pittsburgh:
acute low back pain
primary care
psychologically informed physical therapy
cluster randomized pragmatic trial
comparative effectiveness
secondary prevention
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms