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| ID | Type | Description | Link |
|---|---|---|---|
| 3UH3AT009763-04S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Utah | OTHER |
| Madigan Army Medical Center | FED |
| Tripler Army Medical Center | FED |
| 59th Medical Wing |
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This study will compare the effectiveness of two pain management pathways (standard vs. enriched) for patients undergoing lumbar spine surgery in the Military Health System (MHS). Effectiveness will be based on post-surgery patient-centered outcomes and extent of opioid use. The study design is a 2-arm, parallel group, individual-randomized trial.
The relevance of our model is supported by evidence that pain catastrophizing, self-efficacy and hypervigilance predict poor surgical outcomes and long-term opioid use. Surgery can exacerbate catastrophic thinking, especially if patients have unrealistic recovery expectations that go unmet. Physical therapy (PT) can improve chronic LBP (low back pain) outcomes, with effects mediated through changes in pain catastrophizing and self-efficacy. Mindfulness techniques help patients disentangle an experience (e.g., pain) from associated emotions and appraisals. Mindfulness can enhance emotion regulation and raise un-conscious behavioral responses (e.g., opioid use) to conscious consideration. The benefits of mindfulness for chronic pain are mediated by changes in hypervigilance and self-efficacy. Physical therapy and mindfulness can disrupt the self-reinforcing cycle of pain, catastrophic appraisal and unconscious behavioral response including opioid use. Our project examines an innovative strategy to integrate mindfulness and PT into an enriched surgical management pathway for individuals undergoing lumbar spine surgery.
Patients at 3 different military hospitals will be randomized prior to surgery to two different treatment groups and followed for a period of 6 months, including the post-operative intervention phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care (SC) | Active Comparator | Standard Post-Surgical Care utilizing opioids. |
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| Enriched Surgical Management Pathway (EMP) | Active Comparator | Enriched Surgical Management Pathway utilizing Physical Therapy and Mindfulness in addition to Standard Protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care (SC) | Behavioral | No attempt will be made to change usual care practice after surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain, Enjoyment, and General Activity Scale (PEG-3) | The PEG-3 measure includes 3 items evaluating 1) pain severity, and interference of pain with 2) enjoyment and 3) general activity. Response options for each item range from 0-10 with higher scores indicating higher pain intensity. The PEG-3 score is expressed as the mean of all item scores. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discontinuation of Opioids After Surgery | The length of time (recorded in days) until a patient discontinues pain medications after surgery. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS)-29 version 2.0 | The PROMIS-29 measures 7 domains of health-related quality of life (pain interference, physical function, anxiety, depression, sleep disturbance, fatigue, and ability to participate in social roles) using 4 items and includes a single 0-10 numeric pain intensity rating scale. Scores are provided as T-scores for all domains and can be used to compute a mental and physical health summary score |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie M Fritz, PhD | University of Utah | Principal Investigator |
| Daniel I Rhon, DSc | Brooke Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tripler Army Medical Center | Honolulu | Hawaii | 96859 | United States | ||
| Brooke Army Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29521813 | Background | Deyo RA, Hallvik SE, Hildebran C, Marino M, O'Kane N, Carson J, Van Otterloo J, Wright DA, Millet LM, Wakeland W. Use of prescription opioids before and after an operation for chronic pain (lumbar fusion surgery). Pain. 2018 Jun;159(6):1147-1154. doi: 10.1097/j.pain.0000000000001202. | |
| 17119140 | Background | Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, Hilibrand AS, Boden SD, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006 Nov 22;296(20):2441-50. doi: 10.1001/jama.296.20.2441. |
| Label | URL |
|---|---|
| HEAL BACPAC | View source |
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Trial data from this trial will be entered into the National Institutes of Health Help End Addiction Long-Term (HEAL)Back Pain Consortium (BACPAC) data repository and coordinating center.
Within 6 months of completion of all trial activities.
Requests to use data from the BACPAC data repository need to go through that organization. Otherwise, reasonable requests will be considered as long as all data sharing agreement (DSA) stipulations from the US Defense Health Agency have been met. More about filling out and submitting DSAs can be found at https://www.health.mil/
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| FED |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Brooke Army Medical Center | FED |
Primary Outcome: The primary analysis will be performed by fitting a longitudinal linear model to the PEG scores at baseline, 2 weeks and 26 weeks.
Secondary Outcome: Kaplan Meier curves with 95% pointwise confidence limits will be constructed to summarize the time to opioid discontinuation in each of the EPM and SC treatment groups. Time to opioid discontinuation will be compared between groups using a stratified log-rank test, with stratification for three randomization stratification factors.
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Study participants and clinicians cannot be blinded to study treatments. Randomization assignment will not be revealed until after enrollment and completion of baseline assessments. Study statisticians cannot be blinded to participants' study treatment assignments because they must complete Data Safety Monitoring Reports and analyze the study outcomes by treatment group. Study investigators will remain blinded to participants' treatment group assignment. Follow-up assessments will be performed by a research assistant who will be blinded to participants' treatment group assignment.
| Enriched Pain Management Pathway (EPM) | Behavioral | Enriched Pain Management Pathway will be delivered by physical therapists trained to integrate physical therapy and mindfulness techniques grounded in a biopsychosocial context. The intervention will be delivered within the context of the post-operative physical therapy routine (the mindfulness approach will be integrated into the post-operative physical therapy care). |
|
| 6 months |
| San Antonio |
| Texas |
| 78234 |
| United States |
| Madigan Army Medical Center | Tacoma | Washington | 98391 | United States |
| 30130023 | Background | Ong KL, Stoner KE, Yun BM, Lau E, Edidin AA. Baseline and postfusion opioid burden for patients with low back pain. Am J Manag Care. 2018 Aug 1;24(8):e234-e240. |
| 17218132 | Background | Woby SR, Urmston M, Watson PJ. Self-efficacy mediates the relation between pain-related fear and outcome in chronic low back pain patients. Eur J Pain. 2007 Oct;11(7):711-8. doi: 10.1016/j.ejpain.2006.10.009. Epub 2007 Jan 10. |
| 27993558 | Background | Morasco BJ, Yarborough BJ, Smith NX, Dobscha SK, Deyo RA, Perrin NA, Green CA. Higher Prescription Opioid Dose is Associated With Worse Patient-Reported Pain Outcomes and More Health Care Utilization. J Pain. 2017 Apr;18(4):437-445. doi: 10.1016/j.jpain.2016.12.004. Epub 2016 Dec 18. |
| 26461996 | Background | Fritz JM, Magel JS, McFadden M, Asche C, Thackeray A, Meier W, Brennan G. Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 13;314(14):1459-67. doi: 10.1001/jama.2015.11648. |
| 29489568 | Background | Rhon DI, Miller RB, Fritz JM. Effectiveness and Downstream Healthcare Utilization for Patients That Received Early Physical Therapy Versus Usual Care for Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2018 Oct 1;43(19):1313-1321. doi: 10.1097/BRS.0000000000002619. |
| 32569762 | Background | Lo YT, Lim-Watson M, Seo Y, Fluetsch N, Alasmari MM, Alsheikh MY, Lamba N, Smith TR, Aglio LS, Mekary RA. Long-Term Opioid Prescriptions After Spine Surgery: A Meta-Analysis of Prevalence and Risk Factors. World Neurosurg. 2020 Sep;141:e894-e920. doi: 10.1016/j.wneu.2020.06.081. Epub 2020 Jun 19. |
| 32202000 | Background | Siglin J, Sorkin JD, Namiranian K. Incidence of Postoperative Opioid Overdose and New Diagnosis of Opioid Use Disorder Among US Veterans. Am J Addict. 2020 Jul;29(4):295-304. doi: 10.1111/ajad.13022. Epub 2020 Mar 22. |
| 29870441 | Background | Schoenfeld AJ, Belmont PJ Jr, Blucher JA, Jiang W, Chaudhary MA, Koehlmoos T, Kang JD, Haider AH. Sustained Preoperative Opioid Use Is a Predictor of Continued Use Following Spine Surgery. J Bone Joint Surg Am. 2018 Jun 6;100(11):914-921. doi: 10.2106/JBJS.17.00862. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |