Back Pain, Neck Pain
Conditions
Brief summary
Low back and neck pain are among the leading causes of medical visits, lost productivity and disability. There is an urgent need to identify effective and efficient ways of helping subjects with acute spine pain while guiding practitioners towards high-value care. This trial will be a block and cluster-randomized open-label multi-centered pragmatic randomized clinical trial comparing healthcare spending and clinical outcomes for subjects with spine pain of less than three months' duration, in whom there are no red flag signs or symptoms. Subjects will be randomized to one of three treatment strategies: (1) usual primary care provider-led care; (2) usual PCP-led care with spine pain treatment directed by the Identify, Coordinate, and Enhanced decision making (ICE) care model, and (3) usual PCP-led care with spine pain treatment directed by the Individualized Postural Therapy (IPT) care model. Our outcomes of interest will be spine-related healthcare utilization at one year as well as pain and functionality of the study participants.
Interventions
OTHERIdentify, Coordinated, Enhanced (ICE) Decision Making + PCP led care
Subjects seeking care at a clinic assigned to this arm will receive the ICE care model through referral by their primary care provider. The ICE care model was developed by the Clinical Excellence Research Center at Stanford University based on a review of the peer-reviewed literature for adult subjects with incident neck or back pain less than six weeks in duration who are not using high-dose opioid medications or receiving spine-related long-term disability payments.
OTHERIndividualized Postural Therapy (IPT) + PCP led care
IPT involves the evaluation of a subject's posture to identify postural and alignment deviations and, based on this, a personalized corrective exercise program is prescribed. This method does involve the use of prescription medications, surgery, or manipulation. A treatment course typically lasts eight sessions over eight weeks. In order to allow for the consistent delivery of this arm of the study at multiple study-sites across the country, IPT will be delivered by The Egoscue Method. Egoscue was founded in 1971 and has 25 clinics worldwide.
OTHERUsual PCP led care
Primary care provider will direct patients' care pathway.
Sponsors
Stanford University
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with back or neck pain of ≤ 3 months' duration. All patients must have spine pain with or without radiation to the extremities or the head * Age ≥ 18 years * Willing and able to provide informed consent
Exclusion criteria
* Patients with symptoms attributed to the spine but without actual pain in the spine (e.g. those with cervicogenic headache without neck pain) * Currently pregnant * Currently receiving disability benefits, worker's compensation, or involved in litigation for a workplace injury * Currently enrolled in another intervention trial for the management of acute back or neck pain * Cancer that is metastatic or being actively treated. (i.e chemotherapy, radiation, surgery) * History of receiving active therapy for back or neck pain in the past 3 months (7+ consecutive days of narcotic use, 6+ sessions of PT, chiropractic care, acupuncture, postural therapy, or other spine therapy delivered by a trained provider) * History of spine surgery or spine injections/ablation in the past 6 months * Severe, active psychosis or major depression inhibiting ability to physically participate in intervention * Red Flag Symptoms (fever, night sweats, unintentional weight loss, bowel or bladder dysfunction, neurologic weakness, history of intravenous drug use)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spine-related Cost of Care at One Year | One year | Measured by patient self-report |
| Change in Pain | Three months | Measured by Oswestry Disability Index The Oswestry Disability Index (ODI) captures pain related disability based on patient self-report. The ODI ranges from 0 (best) to 100 (worst). The Minimal clinically important difference (MCID) for ODI in patients with spine pain is 6 points. The change in participant-level pain related disability from baseline to 3 months using the Oswestry Disability Index has been reported. Reference: Fairbank JCT, Couper J, Davies JB, O'Brien JP. The Oswestry Low Back Pain Disability Questionnaire. Physiotherapy. 1980;66:271-273 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | One year | Measured by Oswestry Disability Index The Oswestry Disability Index (ODI) captures pain related disability based on patient self-report. The ODI ranges from 0 (best) to 100 (worst). The MCID for ODI in patients with spine pain is 6 points. The change in participant-level pain related disability from baseline to 12 months using the Oswestry Disability Index has been reported. Reference: Fairbank JCT, Couper J, Davies JB, O'Brien JP. The Oswestry Low Back Pain Disability Questionnaire. Physiotherapy. 1980;66:271-273 |
| Quality of Life (EQ5D-5L VAS Scores) | One year | EuroQol 5-Dimensional Visual Analogue Scale (EQ-5D-5L VAS) by the EuroQol Group measures patient's self-rated health-related quality of life on a vertical visual analog scale. EQ-5D-5L VAS range from 0 to 100, with 100 indicating the best score. The MCID for the EQ-5D-5L visual analogue scale ranges from 5.3 to 10.5. The health-related quality of life at 12 months using the EQ-5D-5L VAS has been reported. |
| Self-efficacy | One year | The Lorig self-efficacy functioning sub-scale items ask individuals how confident they are in performing certain daily activities. Lorig self-efficacy functioning sub-scale scores range from 0 to 100, with 100 indicating the best score. The MCID for the Lorig self-efficacy scale has not been established. The patient-reported self-efficacy at 12 months using the Lorig self-efficacy functioning sub-scale has been reported. Reference: Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107. PMID: 2912463. |
Countries
United States
Participant flow
Recruitment details
Individuals ≥18 years with neck and/or back pain of ≤3 months' duration were eligible if they presented to one of the 33 participating primary care clinics in the U.S. between June 2017 and March 2020.
Pre-assignment details
This study was randomized at the clinic level. Once clinics were randomized, all patients within that clinic were in that clinic's assigned arm. Patients who consented AND completed baseline questionnaires are included in the primary analytic dataset.
Participants by arm
| Arm | Count |
|---|---|
| Usual PCP Led Care Usual PCP led care: Primary care provider will direct patients' care pathway. | 992 |
| Identify, Coordinated, Enhanced (ICE) Decision Making Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care: Subjects seeking care at a clinic assigned to this arm will receive the ICE care model through referral by their primary care provider. The ICE care model was developed by the Clinical Excellence Research Center at Stanford University based on a review of the peer-reviewed literature for adult subjects with incident neck or back pain less than six weeks in duration who are not using high-dose opioid medications or receiving spine-related long-term disability payments. | 829 |
| Individualized Postural Therapy (IPT) Individualized Postural Therapy (IPT) + PCP led care: IPT involves the evaluation of a subject's posture to identify postural and alignment deviations and, based on this, a personalized corrective exercise program is prescribed. This method does involve the use of prescription medications, surgery, or manipulation. A treatment course typically lasts eight sessions over eight weeks. In order to allow for the consistent delivery of this arm of the study at multiple study-sites across the country, IPT will be delivered by The Egoscue Method. Egoscue was founded in 1971 and has 25 clinics worldwide. | 1,150 |
| Total | 2,971 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Investigator terminated | 1 | 6 | 3 |
| Overall Study | Missing Baseline data | 43 | 42 | 31 |
| Overall Study | Withdrawal by Subject | 51 | 73 | 104 |
Baseline characteristics
| Characteristic | Usual PCP Led Care | Identify, Coordinated, Enhanced (ICE) Decision Making | Individualized Postural Therapy (IPT) | Total |
|---|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 16 | 50.9 years STANDARD_DEVIATION 16 | 52.6 years STANDARD_DEVIATION 16 | 51.7 years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 108 Participants | 131 Participants | 112 Participants | 351 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 884 Participants | 698 Participants | 1038 Participants | 2620 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 4 Participants | 7 Participants | 17 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 17 Participants | 38 Participants | 73 Participants |
| Race (NIH/OMB) Black or African American | 202 Participants | 77 Participants | 115 Participants | 394 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 6 Participants | 13 Participants | 32 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 113 Participants | 127 Participants | 117 Participants | 357 Participants |
| Race (NIH/OMB) White | 640 Participants | 598 Participants | 860 Participants | 2098 Participants |
| Sex: Female, Male Female | 590 Participants | 514 Participants | 688 Participants | 1792 Participants |
| Sex: Female, Male Male | 402 Participants | 315 Participants | 462 Participants | 1179 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Pain
Measured by Oswestry Disability Index The Oswestry Disability Index (ODI) captures pain related disability based on patient self-report. The ODI ranges from 0 (best) to 100 (worst). The Minimal clinically important difference (MCID) for ODI in patients with spine pain is 6 points. The change in participant-level pain related disability from baseline to 3 months using the Oswestry Disability Index has been reported. Reference: Fairbank JCT, Couper J, Davies JB, O'Brien JP. The Oswestry Low Back Pain Disability Questionnaire. Physiotherapy. 1980;66:271-273
Time frame: Three months
Population: The analytic cohort included patients who consented AND completed baseline questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual PCP Led Care | Change in Pain | -9.4 score on a scale | Standard Deviation 18.3 |
| Identify, Coordinated, Enhanced (ICE) Decision Making | Change in Pain | -15.9 score on a scale | Standard Deviation 16.2 |
| Individualized Postural Therapy (IPT) | Change in Pain | -13.9 score on a scale | Standard Deviation 15.9 |
p-value: <0.00195% CI: [-7.7, -3.9]GEE with identity link and normal errors
p-value: <0.00195% CI: [-5.9, -2.6]GEE with identity link and normal errors
Primary
Spine-related Cost of Care at One Year
Measured by patient self-report
Time frame: One year
Population: The primary analytic cohort included patients who consented AND completed baseline questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual PCP Led Care | Spine-related Cost of Care at One Year | 1587 dollars | Standard Deviation 5774 |
| Identify, Coordinated, Enhanced (ICE) Decision Making | Spine-related Cost of Care at One Year | 1448 dollars | Standard Deviation 2756 |
| Individualized Postural Therapy (IPT) | Spine-related Cost of Care at One Year | 2528 dollars | Standard Deviation 2756 |
p-value: 0.0495% CI: [0.87, 0.997]GEE with log link and Poisson errors
p-value: <0.00195% CI: [1.35, 1.45]GEE with log link and Poisson errors
Secondary
Change in Pain
Measured by Oswestry Disability Index The Oswestry Disability Index (ODI) captures pain related disability based on patient self-report. The ODI ranges from 0 (best) to 100 (worst). The MCID for ODI in patients with spine pain is 6 points. The change in participant-level pain related disability from baseline to 12 months using the Oswestry Disability Index has been reported. Reference: Fairbank JCT, Couper J, Davies JB, O'Brien JP. The Oswestry Low Back Pain Disability Questionnaire. Physiotherapy. 1980;66:271-273
Time frame: One year
Population: The analytic cohort included patients who consented AND completed baseline questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual PCP Led Care | Change in Pain | -9.2 score on a scale | Standard Deviation 18.9 |
| Identify, Coordinated, Enhanced (ICE) Decision Making | Change in Pain | -17.7 score on a scale | Standard Deviation 16.4 |
| Individualized Postural Therapy (IPT) | Change in Pain | -16.3 score on a scale | Standard Deviation 16.1 |
p-value: <0.00195% CI: [-9.4, -5.7]GEE with identity link and normal errors
p-value: <0.00195% CI: [-8.4, -5]GEE with identity link and normal errors
Secondary
Quality of Life (EQ5D-5L VAS Scores)
EuroQol 5-Dimensional Visual Analogue Scale (EQ-5D-5L VAS) by the EuroQol Group measures patient's self-rated health-related quality of life on a vertical visual analog scale. EQ-5D-5L VAS range from 0 to 100, with 100 indicating the best score. The MCID for the EQ-5D-5L visual analogue scale ranges from 5.3 to 10.5. The health-related quality of life at 12 months using the EQ-5D-5L VAS has been reported.
Time frame: One year
Population: The analytic cohort included patients who consented AND completed baseline questionnaires.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual PCP Led Care | Quality of Life (EQ5D-5L VAS Scores) | 3.2 score on a scale |
| Identify, Coordinated, Enhanced (ICE) Decision Making | Quality of Life (EQ5D-5L VAS Scores) | 8.9 score on a scale |
| Individualized Postural Therapy (IPT) | Quality of Life (EQ5D-5L VAS Scores) | 10.5 score on a scale |
p-value: <0.00195% CI: [2.6, 6.8]GEE with identity link and normal errors
p-value: <0.00195% CI: [4.1, 7.9]GEE with identity link and normal errors
Secondary
Self-efficacy
The Lorig self-efficacy functioning sub-scale items ask individuals how confident they are in performing certain daily activities. Lorig self-efficacy functioning sub-scale scores range from 0 to 100, with 100 indicating the best score. The MCID for the Lorig self-efficacy scale has not been established. The patient-reported self-efficacy at 12 months using the Lorig self-efficacy functioning sub-scale has been reported. Reference: Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107. PMID: 2912463.
Time frame: One year
Population: The analytic cohort included patients who consented AND completed baseline questionnaires.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual PCP Led Care | Self-efficacy | -1.0 score on a scale |
| Identify, Coordinated, Enhanced (ICE) Decision Making | Self-efficacy | 7.4 score on a scale |
| Individualized Postural Therapy (IPT) | Self-efficacy | 6.4 score on a scale |
p-value: <0.00195% CI: [5, 8.7]GEE with identity link and normal errors
p-value: <0.00195% CI: [5, 8.4]GEE with identity link and normal errors