This project has results

Comparing Ways to Treat Low Back Pain and Prevent Chronic Pain and Disability -- The TARGET Trial

Results Summary and Professional Abstract

Results Summary

What was the research about?

Low back pain is a common reason people seek health care. For most, the pain is temporary. For others, the pain persists. This chronic pain causes problems with sitting, walking, working, or other activities. Some patients may be at higher risk of developing chronic pain than others.

In this study, the research team looked separately at patients with recent low back pain who had different risks for developing chronic pain. To assess chronic pain risk, the team asked patients questions about how they were coping with back pain.

For patients at high risk, the research team compared two types of care:

Usual care, which included home treatment such as over-the-counter pain medicine.
Usual care plus a referral to psychologically informed physical therapy, or PIPT. PIPT helps patients learn coping skills to manage back pain.

For patients at low or medium risk of chronic low back pain, the team looked at patients’ rates of chronic back pain six months after they received usual care.

What were the results?

Of patients at high risk, 50 percent developed chronic pain with both types of care. Level of disability and use of health care for low back pain were also similar for both types of care.

After six months, 20 percent of low-risk and 33 percent of medium-risk patients developed chronic low back pain. Also, 30 to 40 percent of low- and medium-risk patients had another doctor visit for low back pain.

For patients at all risk levels, doctors often ordered non-recommended tests and treatments, such as x-rays and opioids.

What did the research team do?

The research team assigned 76 clinics from four health systems across the United States by chance to one of the two groups. In the PIPT group, the research team asked doctors to refer high-risk patients to physical therapists trained in PIPT. In the other group, doctors provided care as usual. The team reviewed the health records of all 2,300 high-risk patients. Of these, 75 percent were White, 17 percent were Black, 4 percent were another race, and 4 percent didn’t report a race; 6 percent were Hispanic. The average age was 50, and 59 percent were women.

Next, the research team reviewed the health records of 7,247 patients at low and medium risk. Of these, 81 percent were White, 13 percent were Black, 3 percent were another race, and 3 percent didn’t report a race; 4 percent were Hispanic. The average age was 51, and 58 percent were women. The team looked at health records to determine how often low back pain turned into chronic pain. They also looked at level of disability and healthcare use.

Patients with low back pain, doctors, and insurers helped plan the study.

What were the limits of the study?

Doctors only referred 40 percent of high-risk patients to PIPT. Results may have differed if doctors had referred more patients to PIPT.

Future research could look at ways to help primary care doctors prevent chronic pain for patients with low back pain.

How can people use the results?

Doctors and patients can use these results when considering ways to treat low back pain.

Professional Abstract

Objective

(1) To compare the effectiveness of usual care versus usual care plus psychologically informed physical therapy (PIPT) in preventing the transition from acute to chronic low back pain and disability among patients at high risk for chronic back pain; (2) To describe rates of transition from acute to chronic low back pain among patients at low to medium risk

Study Design

Design Element	Description
Design	Pragmatic cluster randomized trial Observational: cohort study
Population	Randomized trial: 2,300 patients ages 18 and older from four health systems across the United States presenting with acute low back pain at primary care clinics and identified as high risk for developing chronic low back pain. Observational cohort: 7,247 patients ages 18 and older at 4 health systems across the United States presenting with acute low back pain at primary care clinics and identified as medium or low risk for developing chronic low back pain.
Interventions/ Comparators	Randomized trial: usual care versus usual care plus PIPT Observational cohort: Not applicable
Outcomes	Primary: patient transition from acute to chronic low back pain, level of low back pain-related disability Secondary: low back pain-related healthcare utilization
Timeframe	6-month follow-up for primary outcomes; 12-month surveillance for secondary outcomes

In a pragmatic cluster randomized trial, researchers randomly assigned 76 primary care clinics to either usual care or usual care plus PIPT. Patients who were already experiencing chronic low back pain were excluded.

All clinics used the STarT Back questionnaire to stratify patient risk level for chronic low back pain as high, medium, or low. In the usual care plus PIPT group, clinics received instructions to refer patients at high risk to local physical therapists trained in PIPT methods, which include using enhanced communication and teaching patients psychologically informed coping skills to manage pain. In the usual care group, clinics received no instructions to alter their normal clinical procedures. Researchers assessed outcomes through electronic health records extraction and follow-up surveys of the 2,300 patients at high risk for chronic low back pain. Of these, 75% were White, 17% were Black, 4% were another race, and 4% declined to answer; 6% were Hispanic. The average age was 50, and 59% were female.

For the 7,247 patients identified as low or medium risk in the randomized trial, researchers reviewed health records to describe the rates of developing chronic low back pain. Of the patients, 81% were White, 13% were Black, 3% were another race, and 3% declined to answer; 4% were Hispanic. The average age was 51, and 58% were female.

Patients with low back pain, clinicians, and health insurers helped design and conduct the study.

Results

In the randomized trial, the usual care and usual care plus PIPT groups had similar proportions of patients who transitioned from acute to chronic low back pain (50%), low back pain-related disability levels, and low back pain-related healthcare utilization. Patients frequently received treatments and tests that are not recommended by guidelines. Clinicians prescribed opioids at 25% of initial visits and imaging at 27% of initial visits.

In the observational cohort, rates of transition to chronic pain were 20% and 33% for patients at low and medium risk, respectively. Non-guideline-recommended treatments and tests were also frequent in this cohort. Clinicians prescribed opioids at 16% and imaging at 23% of initial visits.

Limitations

Clinicians in the usual care plus PIPT group had a low referral rate of patients to PIPT (40%), which may have affected the results.

Conclusions and Relevance

In this study, usual care plus PIPT did not demonstrate a reduction in transition from acute to chronic low back pain or a lower level of low back pain-related disability, compared with usual care alone.

Future Research Needs

Future research could explore ways to assist primary care clinicians in preventing the transition from acute to chronic low back pain.

This project's final research report is expected to be available by September 2021.

Journal Articles

BMC Musculoskeletal Disorders

Implementing stratified care for acute low back pain in primary care using the STarT Back instrument: a process evaluation within the context of a large pragmatic cluster randomized trial

Contemporary Clinical Trials

Study protocol for targeted interventions to prevent chronic low back pain in high-risk patients: A multi-site pragmatic cluster randomized controlled trial (TARGET Trial)

Trials

Targeted interventions to prevent transitioning from acute to chronic low back pain in high-risk patients: development and delivery of a pragmatic training course of psychologically informed physical therapy for the TARGET trial

Physical Therapy

Pragmatic Clinical Trials: Implementation Opportunity, or Just Another Fad?

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

The reviewers asked for more information on what interventions patients received during physical therapy. The researchers stated that they did not have this information because they designed the study pragmatically, focusing on training physical therapists in psychologically-informed physical therapy (PIPT), and providing a checklist to remind physical therapists about this model. Therefore, the researchers did not measure adherence to PIPT.
The reviewers asked whether PIPT-trained physical therapists treated any patients in the usual care group and vice versa, since physical therapists in the referral area of the intervention primary care clinics received the PIPT training but were not limited to only seeing patients from the intervention primary care clinics. The researchers acknowledged that they did not have a way to match up PIPT-trained physical therapists with intervention group patients only, nor could they check to see if these physical therapists treated any patients in the usual care group.
The reviewers questioned the references to the care practices in the control group as guideline-based care, given the variability of those care practices and how often the treatment for low-back pain was not in line with current care guidelines. The researchers explained that they had been encouraged to use guideline-based care to more specifically describe the expected interventions in the control group but agreed that the term usual care better described the variability of clinical practices in the control group. Although the researchers had been told that usual care would not be a specific enough comparator, the reviewers felt that usual care was an appropriate control group in a pragmatic trial.

Conflict of Interest Disclosures

View the COI disclosure form.

Project Details

Principal Investigator

Anthony Delitto, PhD, PT, FAPTA

Project Status

Completed; PCORI Public and Professional Abstracts Posted

Project Title

Comparing Two Approaches to Prevent Long-Term Low Back Pain in High-Risk Patients -- The TARGET Trial

Board Approval Date

February 2015

Project End Date

December 2020

Organization

University of Pittsburgh

Year Awarded

2015

State

Pennsylvania

Year Completed

2020

Project Type

Research Project

Health Conditions

Mental/Behavioral Health

Depression

Multiple/Comorbid Chronic Conditions

Muscular and Skeletal Disorders

Chronic Back Pain

Nutritional and Metabolic Disorders

Obesity

Trauma/Injuries

Occupational Injury

Intervention Strategies

Behavioral Interventions
Other Clinical Interventions
Care Coordination
Training and Education Interventions

Populations

Individuals with Multiple Chronic/co-morbid Conditions
Low Income
Racial/Ethnic Minorities
Rural
Urban

Funding Announcement

Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes

Project Budget

$8,744,371

Study Registration Information

HSRP20153600

NCT02647658

Page Last Updated:

January 25, 2021