Randomized Trial on the Clinical Utility of a Novel Biomarker Panel to Identify Treatable Determinants of Chronic Pain
Abstract
:1. Introduction
2. Materials and Methods
2.1. Ethics
2.2. Physician Selection
2.3. Intervention
2.4. Analysis
3. Results
3.1. Clinical Performance after the Introduction of the Foundation Pain Index (FPI) Test
3.2. Diagnosing Chronic Pain and Co-Morbidities
3.3. Treatment of Chronic Pain and Co-Morbidities
3.4. Diagnosing Pain Pathways
3.5. Treating Pain Pathways
3.6. Patients with Mental Health Diagnoses
3.7. Patients on Chronic Opioids
3.8. Unnecessary Imaging and Pain Referrals for Low Back Pain
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Conflicts of Interest
References
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Case | Primary Diagnosis | Primary Contributing Diagnosis | Secondary Diagnosis/Co-Morbidity |
---|---|---|---|
Case Type 1: Chronic Central Pain with Mental Health-Related Comorbidities | |||
1A | Lumbar spinal stenosis | Vitamin B12 deficiency Low serotonin synthesis | Depression Hypertension |
1B | Phantom limb pain | Vitamin B12 and B6 deficiencies | Anxiety disorder Hypertension Dyslipidemia |
1C | Non-specific chronic low back pain | - | Depression |
Case Type 2: Chronic Neuropathic Pain | |||
2A | Distal symmetric polyneuropathy, likely from diabetes | Vitamin B12 deficiency Carnitine depletion | Type 2 DM CKD stage 3 Dyslipidemia |
2B | Distal symmetric polyneuropathy, idiopathic | Functional vitamin B12 deficiency Carnitine depletion | Type 1 DM CKD stage 2 GERD |
2C | Distal symmetric polyneuropathy, idiopathic | - | Depression Obesity |
Case Type 3: Chronic Pain Associated with Other Causes | |||
3A | Intractable migraine Medication overuse headache | Glutathione depletion from chronic acetaminophen intake Acrolein exposure | Fibromyalgia |
3B | Chronic pain syndrome Chronic fatigue | Severe vitamin B6 deficiency Acrolein exposure | - |
3C | Lumbar spinal stenosis | - | GERD Opioid-related constipation and sedation |
Variables | Control | Intervention | p-Value |
---|---|---|---|
N | 76 | 75 | -- |
Male | 72.4% | 80.0% | 0.271 |
Age | 55.4 ± 9.1 | 55.9 ± 8.7 | 0.707 |
Board Certification * | |||
Family Medicine | 52.6% | 50.7% | 0.809 |
Internal Medicine | 44.7% | 48.0% | 0.688 |
Neurology | 0.0% | 1.3% | 0.312 |
PM&R | 2.6% | 2.7% | 0.989 |
Other | 4.0% | 9.3% | 0.183 |
Years in Practice | 25.3 ± 8.4 | 27.3 ± 9.0 | 0.151 |
Region | |||
Midwest | 25.0% | 16.0% | 0.434 |
Northeast | 21.1% | 29.3% | |
South | 19.7% | 17.3% | |
West | 34.2% | 37.3% | |
Locale | |||
Urban | 29.0% | 26.7% | 0.791 |
Suburban | 60.5% | 65.3% | |
Rural | 10.5% | 8.0% | |
Employed by Practice, % | 73.7% | 85.3% | 0.076 |
Practice Setting | |||
Private Practice, Solo | 18.4% | 18.7% | 0.614 |
Private Practice, Single Specialty | 31.6% | 42.7% | |
Private Practice, Multi-Specialty | 35.5% | 25.3% | |
Hospital-Based | 9.2% | 9.3% | |
Federally-Qualified Health Center | 5.3% | 4.0% | |
Outpatient Time, % | 89.0% ± 24.1% | 91.2% ± 18.5% | 0.526 |
Payer Type | |||
Public (Medicare/Medicaid) | 42.7% ± 19.7% | 40.3% ± 18.5% | 0.444 |
Commercial | 48.1% ± 21.7% | 50.9% ± 20.7% | 0.434 |
Self | 5.4% ± 6.0% | 6.8% ± 13.0% | 0.371 |
Other | 3.8% ± 16.1% | 2.0% ± 4.5% | 0.356 |
CMS Quality Participation 1 | |||
MIPS | 29.0% | 40.0% | 0.153 |
BPCI | 10.5% | 13.3% | 0.595 |
Other | 4.0% | 6.7% | 0.456 |
Do not participate | 43.4% | 32.0% | 0.148 |
Don’t know | 21.1% | 12.0% | 0.135 |
Receive Quality Bonus | 44.7% | 45.3% | 0.941 |
Diagnosis and Treatment | Round | ||
---|---|---|---|
1 | 2 | p-value | |
Control | 23.6% ± 15.0% | 20.1% ± 11.4% | 0.006 * |
Intervention | 21.0% ± 13.4% | 26.8% ± 16.9% | <0.001 * |
p-value | 0.055 * | <0.001 * | <0.001 † |
Primary Pain Diagnosis | Round | ||
1 | 2 | p-value | |
Control | 83.2% | 83.8% | 0.866 ‡ |
Intervention | 79.0% | 85.3% | 0.080 ‡ |
p-value | 0.259 ‡ | 0.646 ‡ | 0.269 § |
Secondary Diagnosis | Round | ||
1 | 2 | p-value | |
Control | 41.0% | 39.1% | 0.701 ‡ |
Intervention | 44.3% | 41.0% | 0.504 ‡ |
p-value | 0.498 ‡ | 0.699 ‡ | 0.839 § |
Nutritional Deficiency Diagnosis | Round | ||
1 | 2 | p-value | |
Control | 7.1% | 13.1% | 0.164 ‡ |
Intervention | 8.9% | 41.5% | <0.001 ‡ |
p-value | 0.647 ‡ | <0.001 ‡ | <0.001 § |
Treatment of Nutritional Deficiency | Round | ||
1 | 2 | p-value | |
Control | 5.0% | 8.8% | 0.249 ‡ |
Intervention | 9.2% | 59.5% | <0.001 ‡ |
p-value | 0.208‡ | <0.001 ‡ | 0.001 § |
Treatment of Oxidative Stress | Round | ||
1 | 2 | p-value | |
Control | 1.2% | 0.5% | 0.494 ‡ |
Intervention | 0.0% | 26.1% | <0.001 ‡ |
p-value | 0.152 ‡ | <0.001 ‡ | <0.001 § |
Treatment of Metabolic Abnormality | Round | ||
1 | 2 | p-value | |
Control | 1.0% | 1.1% | 0.929 ‡ |
Intervention | 0.0% | 29.4% | <0.001 ‡ |
p-value | 0.314 ‡ | <0.001 ‡ | <0.001 § |
(a) | ||
---|---|---|
Variable | Coef. | p > t |
Male | −2.7 | 0.017 |
Age group (ref age < 50) | ||
50–59 | 3.1 | 0.009 |
60+ | 5.5 | 0.000 |
Family medicine | 1.6 | 0.100 |
Northeast | −2.1 | 0.060 |
Urban setting | 0.0 | 0.980 |
Solo, private practice | −3.4 | 0.007 |
Intervention | −2.5 | 0.065 |
Round | −3.5 | 0.008 |
Intervention * round | 9.3 | 0.000 |
Constant | 23.0 | 0.000 |
(b) | |||
---|---|---|---|
[95% Conf. Interval] | |||
Variable | Odds Ratio | Lower | Upper |
Male | 0.5 | 0.3 | 1.0 |
Age group (ref age < 50) | |||
50–59 | 1.0 | 0.5 | 2.1 |
60+ | 1.0 | 0.4 | 2.1 |
Family medicine | 0.5 | 0.3 | 0.9 |
Northeast | 1.2 | 0.6 | 2.3 |
Urban setting | 1.4 | 0.8 | 2.6 |
Solo, private practice | 0.7 | 0.3 | 1.5 |
Intervention | 1.3 | 0.4 | 3.6 |
Round | 1.9 | 0.7 | 5.0 |
Intervention * round | 4.1 | 1.1 | 14.4 |
Constant | 0.2 | 0.1 | 0.4 |
(c) | |||
---|---|---|---|
[95% Conf. Interval] | |||
Variable | Odds Ratio | Lower | Upper |
Male | 0.5 | 0.2 | 1.1 |
Age group (ref age < 50) | |||
50–59 | 0.9 | 0.3 | 2.2 |
60+ | 0.9 | 0.3 | 2.5 |
Family medicine | 0.8 | 0.4 | 1.8 |
Northeast | 0.5 | 0.2 | 1.2 |
Urban setting | 1.2 | 0.5 | 2.9 |
Solo, private practice | 1.5 | 0.6 | 3.8 |
Diagnosis of nutritional deficiency | 61.2 | 24.0 | 156.1 |
Intervention | 3.2 | 0.8 | 12.8 |
Round | 1.6 | 0.4 | 6.4 |
Intervention * round | 6.3 | 1.2 | 33.6 |
Constant | 0.0 | 0.0 | 0.2 |
(d) | |||
---|---|---|---|
[95% Conf. Interval] | |||
Variable | Odds Ratio | Lower | Upper |
Male | 1.2 | 0.8 | 1.9 |
Age group (ref age < 50) | |||
50–59 | 0.9 | 0.6 | 1.5 |
60+ | 0.8 | 0.5 | 1.3 |
Family medicine | 0.8 | 0.6 | 1.2 |
Northeast | 0.9 | 0.6 | 1.5 |
Urban setting | 1.1 | 0.7 | 1.7 |
Solo, private practice | 1.1 | 0.7 | 1.8 |
Intervention | 0.8 | 0.5 | 1.4 |
Round | 0.7 | 0.4 | 1.2 |
Intervention * round | 1.8 | 0.8 | 3.7 |
Constant | 0.6 | 0.3 | 1.1 |
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Peabody, J.; Paculdo, D.; Tamondong-Lachica, D.; Cabaluna, I.T.; Gunn, J. Randomized Trial on the Clinical Utility of a Novel Biomarker Panel to Identify Treatable Determinants of Chronic Pain. Diagnostics 2020, 10, 513. https://doi.org/10.3390/diagnostics10080513
Peabody J, Paculdo D, Tamondong-Lachica D, Cabaluna IT, Gunn J. Randomized Trial on the Clinical Utility of a Novel Biomarker Panel to Identify Treatable Determinants of Chronic Pain. Diagnostics. 2020; 10(8):513. https://doi.org/10.3390/diagnostics10080513
Chicago/Turabian StylePeabody, John, David Paculdo, Diana Tamondong-Lachica, Ian Theodore Cabaluna, and Joshua Gunn. 2020. "Randomized Trial on the Clinical Utility of a Novel Biomarker Panel to Identify Treatable Determinants of Chronic Pain" Diagnostics 10, no. 8: 513. https://doi.org/10.3390/diagnostics10080513
APA StylePeabody, J., Paculdo, D., Tamondong-Lachica, D., Cabaluna, I. T., & Gunn, J. (2020). Randomized Trial on the Clinical Utility of a Novel Biomarker Panel to Identify Treatable Determinants of Chronic Pain. Diagnostics, 10(8), 513. https://doi.org/10.3390/diagnostics10080513