Low Back Pain
Conditions
Keywords
acute low back pain, primary care, psychologically informed physical therapy, cluster randomized pragmatic trial, comparative effectiveness, secondary prevention
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.
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.
Interventions
BEHAVIORALGuideline 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
BEHAVIORALGuideline Based Care (GBC)
Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
Sponsors
Boston Medical Center
Intermountain Health Care, Inc.
Johns Hopkins University
Medical University of South Carolina
Patient-Centered Outcomes Research Institute
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel assignment of clusters (clinics). Cluster randomized trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Prescribed Opioids | 12 months | Medication prescription for opioids measured using electronic health records over 12 months. |
| Number of Patients With Orders for Diagnostic Imaging Tests | 12 months | Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records |
| Number of Patients Referred to Surgery Specialist | 12 months | Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records |
| Number of Patients Undergoing Interventional Pain Procedures | 12 months | Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records |
| Number of Patients Who Had Back Surgery | 12 months | Documentation that patient underwent back surgery in electronic health records |
| 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 |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GBC+PIPT 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 | 1,207 |
| Guideline Based Care 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 | 1,093 |
| Total | 2,300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Consent refusal | 15 | 24 |
Baseline characteristics
| Characteristic | GBC+PIPT | Total | Guideline Based Care |
|---|---|---|---|
| Age, Continuous | 49.3 years STANDARD_DEVIATION 16.2 | 49.9 years STANDARD_DEVIATION 16.6 | 50.6 years STANDARD_DEVIATION 17.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 75 Participants | 147 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1087 Participants | 2082 Participants | 995 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 45 Participants | 71 Participants | 26 Participants |
| Oswestry Disability Index | 48.0 score on scale STANDARD_DEVIATION 17.4 | 48.1 score on scale STANDARD_DEVIATION 17.4 | 48.3 score on scale STANDARD_DEVIATION 17.5 |
| Race/Ethnicity, Customized Race Black | 181 Participants | 405 Participants | 224 Participants |
| Race/Ethnicity, Customized Race Missing/Unknown | 52 Participants | 95 Participants | 43 Participants |
| Race/Ethnicity, Customized Race Other | 25 Participants | 82 Participants | 57 Participants |
| Race/Ethnicity, Customized Race White | 949 Participants | 1718 Participants | 769 Participants |
| Sex: Female, Male Female | 721 Participants | 1356 Participants | 635 Participants |
| Sex: Female, Male Male | 486 Participants | 944 Participants | 458 Participants |
| STarT Back Subscore | 4.4 score on a scale STANDARD_DEVIATION 0.5 | 4.4 score on a scale STANDARD_DEVIATION 0.5 | 4.3 score on a scale STANDARD_DEVIATION 0.5 |
| STarT Back Total | 7.2 score on a scale STANDARD_DEVIATION 1.1 | 7.2 score on a scale STANDARD_DEVIATION 1.1 | 7.2 score on a scale STANDARD_DEVIATION 1.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 1,207 | 12 / 1,093 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 6 months
Population: Participants with assessment data at 6 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GBC+PIPT | Functional Disability | 27.3 score on a scale |
| Guideline Based Care | Functional Disability | 29.5 score on a scale |
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.
Time frame: 6 months from baseline
Population: Among participants with assessment data at 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBC+PIPT | Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP) | 312 Participants |
| Guideline Based Care | Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP) | 318 Participants |
Secondary
Number of Patients Prescribed Opioids
Medication prescription for opioids measured using electronic health records over 12 months.
Time frame: 12 months
Population: All screened excluding patients that did not consent to EMR data at 12 months at 1 site.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBC+PIPT | Number of Patients Prescribed Opioids | 89 Participants |
| Guideline Based Care | Number of Patients Prescribed Opioids | 86 Participants |
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
Time frame: 12 months
Population: All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBC+PIPT | Number of Patients Referred to Other Rehabilitation or Pain Management Specialist | 45 Participants |
| Guideline Based Care | Number of Patients Referred to Other Rehabilitation or Pain Management Specialist | 26 Participants |
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.
Time frame: 12 months
Population: All screened excluding those not consented for EMR follow up at 12 months at 1 site.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBC+PIPT | Number of Patients Referred to Physical Therapy | 106 Participants |
| Guideline Based Care | Number of Patients Referred to Physical Therapy | 77 Participants |
Secondary
Number of Patients Referred to Surgery Specialist
Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records
Time frame: 12 months
Population: All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBC+PIPT | Number of Patients Referred to Surgery Specialist | 38 Participants |
| Guideline Based Care | Number of Patients Referred to Surgery Specialist | 44 Participants |
Secondary
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
Population: All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBC+PIPT | Number of Patients Undergoing Interventional Pain Procedures | 32 Participants |
| Guideline Based Care | Number of Patients Undergoing Interventional Pain Procedures | 43 Participants |
Secondary
Number of Patients Who Had Back Surgery
Documentation that patient underwent back surgery in electronic health records
Time frame: 12 months
Population: All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBC+PIPT | Number of Patients Who Had Back Surgery | 29 Participants |
| Guideline Based Care | Number of Patients Who Had Back Surgery | 19 Participants |
Secondary
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
Population: All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBC+PIPT | Number of Patients With Orders for Diagnostic Imaging Tests | 74 Participants |
| Guideline Based Care | Number of Patients With Orders for Diagnostic Imaging Tests | 73 Participants |
Other Pre-specified
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBC+PIPT | Number of Patients Prescribed Opioids | 300 Participants |
| Guideline Based Care | Number of Patients Prescribed Opioids | 270 Participants |
Other Pre-specified
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBC+PIPT | Number of Patients Referred to Physical Therapy | 658 Participants |
| Guideline Based Care | Number of Patients Referred to Physical Therapy | 335 Participants |