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Non-pharmacological Treatment for Pain After Spine Surgery

Primary Purpose

Low Back Pain, Chronic Pain, Surgery

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard Care (SC)

Enriched Pain Management Pathway (EPM)

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring chronic pain, low back pain, spine surgery, non-pharmacological treatment, mindfulness, physical therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Tripler Army Medical Center
Brooke Army Medical CenterRecruiting
Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Standard Care (SC)

Enriched Surgical Management Pathway (EMP)

Arm Description

Standard Post-Surgical Care utilizing opioids.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Discontinuation of Opioids After Surgery

The length of time (recorded in days) until a patient discontinues pain medications after surgery.

Full Information

NCT ID

NCT04770480

First Posted

February 22, 2021

Last Updated

April 18, 2023

Sponsor

Dan Rhon

Collaborators

University of Utah, Madigan Army Medical Center, Tripler Army Medical Center, 59th Medical Wing, National Center for Complementary and Integrative Health (NCCIH), Brooke Army Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04770480

Brief Title

Non-pharmacological Treatment for Pain After Spine Surgery

Official Title

Exploring Non-pharmacological Approaches to Pain Management After Lumbar Surgery: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 10, 2021 (Actual)

Primary Completion Date

October 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dan Rhon

Collaborators

University of Utah, Madigan Army Medical Center, Tripler Army Medical Center, 59th Medical Wing, National Center for Complementary and Integrative Health (NCCIH), Brooke Army Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

InvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

272 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Care (SC)

Arm Type

Active Comparator

Arm Description

Standard Post-Surgical Care utilizing opioids.

Arm Title

Enriched Surgical Management Pathway (EMP)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Standard Care (SC)

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Enriched Pain Management Pathway (EPM)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Pain, Enjoyment, and General Activity Scale (PEG-3)

Description

Time Frame

6 Months

Secondary Outcome Measure Information:

Title

Time to Discontinuation of Opioids After Surgery

Description

The length of time (recorded in days) until a patient discontinues pain medications after surgery.

Time Frame

6 Months

Other Pre-specified Outcome Measures:

Title

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

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mary Laugesen, DPT

Phone

(210)-808-2575

mary.c.laugesen.ctr@mail.mil

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie M Fritz, PhD

Organizational Affiliation

University of Utah

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Daniel I Rhon, DSc

Organizational Affiliation

Brooke Army Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tripler Army Medical Center

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96859

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paola Olvera-Munoz

Phone

808-433-3561

molvera@genevausa.org

First Name & Middle Initial & Last Name & Degree

Matthew Cage, MD

Facility Name

Brooke Army Medical Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mary Laugesen, DPT

Phone

210-916-3303

mary.c.laugesen.ctr@mail.mil

First Name & Middle Initial & Last Name & Degree

Rich Hurley, MD

First Name & Middle Initial & Last Name & Degree

Bryan Pickens, DPT, DSc

Facility Name

Madigan Army Medical Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98391

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rachel J Mayhew, DPT

rachel.J.mayhew.ctr@mail.mil

First Name & Middle Initial & Last Name & Degree

Lisa Konitzer, DSc

First Name & Middle Initial & Last Name & Degree

Dan Kang, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

Within 6 months of completion of all trial activities.

IPD Sharing 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/

IPD Sharing URL

https://www.health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Submit-a-Data-Sharing-Application

Citations:

PubMed Identifier

29521813

Citation

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.

Results Reference

background

PubMed Identifier

17119140

Citation

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.

Results Reference

background

PubMed Identifier

30130023

Citation

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.

Results Reference

background

PubMed Identifier

17218132

Citation

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.

Results Reference

background

PubMed Identifier

27993558

Citation

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.

Results Reference

background

PubMed Identifier

26461996

Citation

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.

Results Reference

background

PubMed Identifier

29489568

Citation

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.

Results Reference

background

PubMed Identifier

32569762

Citation

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.

Results Reference

background

PubMed Identifier

32202000

Citation

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.

Results Reference

background

PubMed Identifier

29870441

Citation

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.

Results Reference

background

Links:

URL

https://heal.nih.gov/research/clinical-research/back-pain

Description

HEAL BACPAC

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Non-pharmacological Treatment for Pain After Spine Surgery

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