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

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT02647658
• Collaborator: Boston Medical Center (Other), Intermountain Health Care, Inc. (Other), Johns Hopkins University (Other), Medical University of South Carolina (Other), Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 2,300
• Locations: 5
• Arms: 2
• Duration (Months): 40
• Patients Per Site: 460
• Patients Per Site Per Month: 11.5

Study Details

Study Description

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)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 2300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel assignment of clusters (clinics). Cluster randomized trial.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: Mar 1, 2016
• Actual Primary Completion Date: Mar 1, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. Number of Patients Prescribed Opioids [12 months]

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

3. Number of Patients With Orders for Diagnostic Imaging Tests [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 [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 [12 months]

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

6. Number of Patients Undergoing Interventional Pain Procedures [12 months]

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

7. Number of Patients Who Had Back Surgery [12 months]

   Documentation that patient underwent back surgery in electronic health records

Other Outcome Measures

1. Number of Patients Prescribed Opioids [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21287
2	Boston Medical Center	Boston	Massachusetts	United States	02118
3	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
4	Medical University of South Carolina	Charleston	South Carolina	United States	29425
5	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

• Principal Investigator: Anthony Delitto, PT, PhD, University of Pittsburgh
• Principal Investigator: Robert Saper, MD, MPH, Boston Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 1, 2018

More Information

Publications

None provided.

• Responsible Party: Anthony Delitto, Professor and Dean, SHRS, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02647658
• Other Study ID Numbers: PCS-1402-10867
• First Posted: Jan 6, 2016
• Last Update Posted: Feb 10, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Anthony Delitto, Professor and Dean, SHRS, 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: Back Pain; Low Back Pain

Study Results

Participant Flow

Arm/Group Title	GBC+PIPT	Guideline Based Care
Arm/Group Description	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 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) Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
Period Title: Overall Study
STARTED	1207	1093
6 Month Assessment	658	635
COMPLETED	1192	1069
NOT COMPLETED	15	24

Baseline Characteristics

Arm/Group Title	GBC+PIPT	Guideline Based Care	Total
Arm/Group Description	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 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) Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives	Total of all reporting groups
Overall Participants	1207	1093	2300
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.3 (16.2)	50.6 (17.1)	49.9 (16.6)
Sex: Female, Male (Count of Participants)
Female	721 59.7%	635 58.1%	1356 59%
Male	486 40.3%	458 41.9%	944 41%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	75 6.2%	72 6.6%	147 6.4%
Not Hispanic or Latino	1087 90.1%	995 91%	2082 90.5%
Unknown or Not Reported	45 3.7%	26 2.4%	71 3.1%
Race/Ethnicity, Customized (Count of Participants)
White	949 78.6%	769 70.4%	1718 74.7%
Black	181 15%	224 20.5%	405 17.6%
Other	25 2.1%	57 5.2%	82 3.6%
Missing/Unknown	52 4.3%	43 3.9%	95 4.1%
Oswestry Disability Index (score on scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on scale]	48.0 (17.4)	48.3 (17.5)	48.1 (17.4)
STarT Back Total (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	7.2 (1.1)	7.2 (1.1)	7.2 (1.1)
STarT Back Subscore (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	4.4 (0.5)	4.3 (0.5)	4.4 (0.5)

Outcome Measures

1. Primary Outcome

Title	Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP)
Description	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.
Time Frame	6 months from baseline

Outcome Measure Data

Analysis Population Description

Among participants with assessment data at 6 months

Arm/Group Title	GBC+PIPT	Guideline Based Care
Arm/Group Description	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 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) Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
Measure Participants	658	635
Count of Participants [Participants]	312 25.8%	318 29.1%

2. Primary Outcome

Title	Functional Disability
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Participants with assessment data at 6 months.

Arm/Group Title	GBC+PIPT	Guideline Based Care
Arm/Group Description	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 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) Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
Measure Participants	658	635
Mean (95% Confidence Interval) [score on a scale]	27.3	29.5

3. Secondary Outcome

Title	Number of Patients Referred to Physical Therapy
Description	Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records over 12 months.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All screened excluding those not consented for EMR follow up at 12 months at 1 site.

Arm/Group Title	GBC+PIPT	Guideline Based Care
Arm/Group Description	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 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) Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
Measure Participants	1192	1069
Count of Participants [Participants]	106 8.8%	77 7%

4. Secondary Outcome

Title	Number of Patients Prescribed Opioids
Description	Medication prescription for opioids measured using electronic health records over 12 months.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All screened excluding patients that did not consent to EMR data at 12 months at 1 site.

Arm/Group Title	GBC+PIPT	Guideline Based Care
Arm/Group Description	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 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) Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
Measure Participants	1192	1069
Count of Participants [Participants]	89 7.4%	86 7.9%

5. Secondary Outcome

Title	Number of Patients With Orders for Diagnostic Imaging Tests
Description	Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.

Arm/Group Title	GBC+PIPT	Guideline Based Care
Arm/Group Description	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 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) Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
Measure Participants	1192	1069
Count of Participants [Participants]	74 6.1%	73 6.7%

6. Secondary Outcome

Title	Number of Patients Referred to Other Rehabilitation or Pain Management Specialist
Description	Referral to any non-physical therapy rehabilitation or pain management specialist (chiropractic, physiatrist, pain management) measured using electronic health records
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.

Arm/Group Title	GBC+PIPT	Guideline Based Care
Arm/Group Description	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 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) Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
Measure Participants	1192	1069
Count of Participants [Participants]	45 3.7%	26 2.4%

7. Secondary Outcome

Title	Number of Patients Referred to Surgery Specialist
Description	Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.

Arm/Group Title	GBC+PIPT	Guideline Based Care
Arm/Group Description	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 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) Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
Measure Participants	1192	1069
Count of Participants [Participants]	38 3.1%	44 4%

8. Secondary Outcome

Title	Number of Patients Undergoing Interventional Pain Procedures
Description	Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.

Arm/Group Title	GBC+PIPT	Guideline Based Care
Arm/Group Description	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 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) Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
Measure Participants	1192	1069
Count of Participants [Participants]	32 2.7%	43 3.9%

9. Secondary Outcome

Title	Number of Patients Who Had Back Surgery
Description	Documentation that patient underwent back surgery in electronic health records
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.

Arm/Group Title	GBC+PIPT	Guideline Based Care
Arm/Group Description	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 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) Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
Measure Participants	1192	1069
Count of Participants [Participants]	29 2.4%	19 1.7%

10. Other Pre-specified Outcome

Title	Number of Patients Prescribed Opioids
Description	Medication prescription for opioids measured using electronic health records at the index baseline visit for the patient. Measure of intervention fidelity post clinic randomization.
Time Frame	Up to 21 days after initial visit for acute low back pain

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GBC+PIPT	Guideline Based Care
Arm/Group Description	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 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) Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
Measure Participants	1207	1093
Count of Participants [Participants]	300 24.9%	270 24.7%

11. Other Pre-specified Outcome

Title	Number of Patients Referred to Physical Therapy
Description	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.
Time Frame	Up to 21 days after initial visit for acute low back pain

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GBC+PIPT	Guideline Based Care
Arm/Group Description	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 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) Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
Measure Participants	1207	1093
Count of Participants [Participants]	658 54.5%	335 30.6%

Adverse Events

Time Frame	Adverse event data were not collected.
Adverse Event Reporting Description	The TARGET trial was a pragmatic trial in four health care systems. As such, we did not collect data on adverse events.
Arm/Group Title	GBC+PIPT		Guideline Based Care
Arm/Group Description	Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 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) Guideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
All Cause Mortality
	GBC+PIPT		Guideline Based Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/1207 (0.7%)		12/1093 (1.1%)
Serious Adverse Events
	GBC+PIPT		Guideline Based Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	GBC+PIPT		Guideline Based Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.