An interventional study of Guideline Based Care plus Psychologically Informed Physical Therapy and Guideline Based Care (GBC) in Low Back Pain, sponsored by University of Pittsburgh. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-10.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 2,300 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Criteria:
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
Behavioral: Guideline Based Care plus Psychologically Informed Physical Therapy
Guideline Based Care (GBC)
Behavioral: Guideline Based Care (GBC)
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
Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
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.
Time frame: 6 months from baseline
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.
Time frame: 6 months
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.
Time frame: 12 months
Number of Patients Prescribed Opioids
Medication prescription for opioids measured using electronic health records over 12 months.
Time frame: 12 months
Number of Patients With Orders for Diagnostic Imaging Tests
Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records
Time frame: 12 months
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
Time frame: 12 months
Number of Patients Referred to Surgery Specialist
Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records
Time frame: 12 months
Number of Patients Undergoing Interventional Pain Procedures
Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records
Time frame: 12 months
Number of Patients Who Had Back Surgery
Documentation that patient underwent back surgery in electronic health records
Time frame: 12 months
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.
Time frame: Up to 21 days after initial visit for acute low back pain
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.
Time frame: Up to 21 days after initial visit for acute low back pain
| Milestone | GBC+PIPT | Guideline Based Care |
|---|---|---|
| Started | 1207 | 1093 |
| 6 month assessment | 658 | 635 |
| Completed | 1192 | 1069 |
| Not completed | 15 | 24 |
| Withdrew: Consent refusal | 15 | 24 |
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.
| Participants | GBC+PIPT | Guideline Based Care |
|---|---|---|
| Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP) | 312 | 318 |
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.
| score on a scale | GBC+PIPT | Guideline Based Care |
|---|---|---|
| Functional Disability | 27.3 (25.4 to 29.3) | 29.5 (27.5 to 31.5) |
Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records over 12 months.
| Participants | GBC+PIPT | Guideline Based Care |
|---|---|---|
| Number of Patients Referred to Physical Therapy | 106 | 77 |
Medication prescription for opioids measured using electronic health records over 12 months.
| Participants | GBC+PIPT | Guideline Based Care |
|---|---|---|
| Number of Patients Prescribed Opioids | 89 | 86 |
Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records
| Participants | GBC+PIPT | Guideline Based Care |
|---|---|---|
| Number of Patients With Orders for Diagnostic Imaging Tests | 74 | 73 |
Referral to any non-physical therapy rehabilitation or pain management specialist (chiropractic, physiatrist, pain management) measured using electronic health records
| Participants | GBC+PIPT | Guideline Based Care |
|---|---|---|
| Number of Patients Referred to Other Rehabilitation or Pain Management Specialist | 45 | 26 |
Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records
| Participants | GBC+PIPT | Guideline Based Care |
|---|---|---|
| Number of Patients Referred to Surgery Specialist | 38 | 44 |
Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records
| Participants | GBC+PIPT | Guideline Based Care |
|---|---|---|
| Number of Patients Undergoing Interventional Pain Procedures | 32 | 43 |
Documentation that patient underwent back surgery in electronic health records
| Participants | GBC+PIPT | Guideline Based Care |
|---|---|---|
| Number of Patients Who Had Back Surgery | 29 | 19 |
Medication prescription for opioids measured using electronic health records at the index baseline visit for the patient. Measure of intervention fidelity post clinic randomization.
| Participants | GBC+PIPT | Guideline Based Care |
|---|---|---|
| Number of Patients Prescribed Opioids | 300 | 270 |
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.
| Participants | GBC+PIPT | Guideline Based Care |
|---|---|---|
| Number of Patients Referred to Physical Therapy | 658 | 335 |
Collected over Adverse event data were not collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GBC+PIPT | 8/1,207 (0.7%) | — | — |
| Guideline Based Care | 12/1,093 (1.1%) | — | — |
| Age, Continuous(years) | GBC+PIPT | Guideline Based Care | Total |
|---|---|---|---|
| Mean | 49.3 ± 16.2 | 50.6 ± 17.1 | 49.9 ± 16.6 |
| Sex: Female, Male(Participants) | GBC+PIPT | Guideline Based Care | Total |
|---|---|---|---|
| Female | 721 | 635 | 1356 |
| Male | 486 | 458 | 944 |
| Ethnicity (NIH/OMB)(Participants) | GBC+PIPT | Guideline Based Care | Total |
|---|---|---|---|
| Hispanic or Latino | 75 | 72 | 147 |
| Not Hispanic or Latino | 1087 | 995 | 2082 |
| Unknown or Not Reported | 45 | 26 | 71 |
| Race/Ethnicity, Customized(Participants) | GBC+PIPT | Guideline Based Care | Total |
|---|---|---|---|
| Race — White | 949 | 769 | 1718 |
| Race — Black | 181 | 224 | 405 |
| Race — Other | 25 | 57 | 82 |
| Race — Missing/Unknown | 52 | 43 | 95 |
| Oswestry Disability Index(score on scale) | GBC+PIPT | Guideline Based Care | Total |
|---|---|---|---|
| Mean | 48.0 ± 17.4 | 48.3 ± 17.5 | 48.1 ± 17.4 |
| STarT Back Total(score on a scale) | GBC+PIPT | Guideline Based Care | Total |
|---|---|---|---|
| Mean | 7.2 ± 1.1 | 7.2 ± 1.1 | 7.2 ± 1.1 |
| STarT Back Subscore(score on a scale) | GBC+PIPT | Guideline Based Care | Total |
|---|---|---|---|
| Mean | 4.4 ± 0.5 | 4.3 ± 0.5 | 4.4 ± 0.5 |
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