Non-pharmacological Treatment for Pain After Spine Surgery
NCT ID: NCT04770480
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
267 participants
INTERVENTIONAL
2021-12-10
2026-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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Standard Care (SC)
Standard Post-Surgical Care utilizing opioids.
Standard Care (SC)
No attempt will be made to change usual care practice after surgery
Enriched Surgical Management Pathway (EMP)
Enriched Surgical Management Pathway utilizing Physical Therapy and Mindfulness in addition to Standard Protocol.
Enriched Pain Management Pathway (EPM)
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).
Interventions
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Standard Care (SC)
No attempt will be made to change usual care practice after surgery
Enriched Pain Management Pathway (EPM)
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).
Eligibility Criteria
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Inclusion Criteria
2. Age 18 - 75 years at the time of enrollment
3. Scheduled to undergo lumbar spine surgery within the next 60 days. Surgery may be laminectomy with or without fusions including lateral, transforaminal, posterior or anterior approach for 1-4 lumbar levels. Surgery may be performed in military or civilian facility
4. Indication for surgery may include disc herniation, degenerative disc disease, lumbar stenosis, degenerative spondylolisthesis or scoliosis.
5. Anticipates ability to attend treatment sessions over a 16 week period following the surgical procedure with no planned absence of 2 weeks or more for training, vacation or any purpose
Exclusion Criteria
2. A microsurgical technique as the primary procedure, such as an isolated laminotomy or microdiscectomy
3. Surgical procedure is a revision or participant has undergone a lumbar surgical procedure in the past year.
4. Contra-indication to participation in post-operative exercise program including severe orthopedic injury limiting mobility, wheelchair dependency, neurological disorder impacting mobility, reliance on supplemental oxygen for daily activity, etc.
5. Pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury
18 Years
75 Years
ALL
No
Sponsors
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University of Utah
OTHER
Madigan Army Medical Center
FED
Tripler Army Medical Center
FED
59th Medical Wing
FED
National Center for Complementary and Integrative Health (NCCIH)
NIH
Brooke Army Medical Center
FED
Dan Rhon
FED
Responsible Party
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Dan Rhon
Director, Primary Care Musculoskeletal Research Center
Principal Investigators
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Julie M Fritz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Daniel I Rhon, DSc
Role: PRINCIPAL_INVESTIGATOR
Brooke Army Medical Center
Locations
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Tripler Army Medical Center
Honolulu, Hawaii, United States
Brooke Army Medical Center
San Antonio, Texas, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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eIRB
Identifier Type: -
Identifier Source: org_study_id
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