Non-pharmacological Treatment for Pain After Spine Surgery

NCT04770480 | Active Not Recruiting DMC

• 2 other identifiers: eIRB3UH3AT009763-04S1
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Low Back Pain; Chronic Pain; Surgery; Back Pain, Low; Back Pain Lower Back Chronic

Keywords

chronic pain; low back pain; spine surgery; non-pharmacological treatment; mindfulness; physical therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time to Discontinuation of Opioids After Surgery

  6 Months

Other Outcomes (1)

• Patient-Reported Outcomes Measurement Information System (PROMIS)-29 version 2.0

  6 months

Study Arms (2)

Standard Care (SC)

ACTIVE COMPARATOR

Standard Post-Surgical Care utilizing opioids.

Behavioral: Standard Care (SC)

Enriched Surgical Management Pathway (EMP)

ACTIVE COMPARATOR

Enriched Surgical Management Pathway utilizing Physical Therapy and Mindfulness in addition to Standard Protocol.

Behavioral: Enriched Pain Management Pathway (EPM)

Interventions

Standard Care (SC) BEHAVIORAL

No attempt will be made to change usual care practice after surgery

Standard Care (SC)

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).

Enriched Surgical Management Pathway (EMP)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tricare beneficiary receiving care in a participating MHS facility.
• Age 18 - 75 years at the time of enrollment
• 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
• Indication for surgery may include disc herniation, degenerative disc disease, lumbar stenosis, degenerative spondylolisthesis or scoliosis.
• 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

You may not qualify if:

• Indication for surgery is infection, fracture, tumor, trauma or other indication requiring emergency surgery.
• A microsurgical technique as the primary procedure, such as an isolated laminotomy or microdiscectomy
• Surgical procedure is a revision or participant has undergone a lumbar surgical procedure in the past year.
• 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.
• Pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury

Sponsors & Collaborators

• Dan Rhon: lead
• University of Utah: collaborator
• Madigan Army Medical Center: collaborator
• Tripler Army Medical Center: collaborator
• 59th Medical Wing: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Brooke Army Medical Center: collaborator

Study Sites (3)

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98391, United States

Location

Related Publications (10)

• 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.

  PMID: 29521813 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.

  PMID: 17119140 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.

  PMID: 30130023 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.

  PMID: 17218132 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.

  PMID: 27993558 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.

  PMID: 26461996 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.

  PMID: 29489568 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.

  PMID: 32569762 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.

  PMID: 32202000 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.

  PMID: 29870441 BACKGROUND

Related Links

• HEAL BACPAC

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Julie M Fritz, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Daniel I Rhon, DSc

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Primary Care Musculoskeletal Research Center

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: December 10, 2021
• Primary Completion: November 30, 2025
• Study Completion: March 30, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 6 months of completion of all trial activities.
• Access Criteria: 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/

Locations

US (3)