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

Low Back Pain Clinical Trial

— TARGET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647658
• Other study ID #: PCS-1402-10867
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2300
• Est. completion date: June 30, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Boston Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Intermountain Healthcare	Salt Lake City	Utah

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Patients Prescribed Opioids	Medication prescription for opioids measured using electronic health records at the index baseline visit for the patient. Measure of intervention fidelity post clinic randomization.	Up to 21 days after initial visit for acute low back pain
Other	Number of Patients Referred to Physical Therapy	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.	Up to 21 days after initial visit for acute low back pain
Primary	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
Primary	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	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
Secondary	Number of Patients Prescribed Opioids	Medication prescription for opioids measured using electronic health records over 12 months.	12 months
Secondary	Number of Patients With Orders for Diagnostic Imaging Tests	Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records	12 months
Secondary	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
Secondary	Number of Patients Referred to Surgery Specialist	Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records	12 months
Secondary	Number of Patients Undergoing Interventional Pain Procedures	Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records	12 months
Secondary	Number of Patients Who Had Back Surgery	Documentation that patient underwent back surgery in electronic health records	12 months