Non-pharmacological Treatment for Pain After Spine Surgery

April 18, 2023 updated by: Dan Rhon

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96859
        • Not yet recruiting
        • Tripler Army Medical Center
        • Contact:
        • Principal Investigator:
          • Matthew Cage, MD
    • Texas
      • San Antonio, Texas, United States, 78234
        • Recruiting
        • Brooke Army Medical Center
        • Contact:
        • Principal Investigator:
          • Rich Hurley, MD
        • Sub-Investigator:
          • Bryan Pickens, DPT, DSc
    • Washington
      • Tacoma, Washington, United States, 98391
        • Not yet recruiting
        • Madigan Army Medical Center
        • Contact:
        • Principal Investigator:
          • Lisa Konitzer, DSc
        • Sub-Investigator:
          • Dan Kang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Tricare beneficiary receiving care in a participating MHS facility.
  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:

  1. Indication for surgery is infection, fracture, tumor, trauma or other indication requiring emergency surgery.
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Care (SC)
Standard Post-Surgical Care utilizing opioids.
Behavioral: Standard Care (SC)
No attempt will be made to change usual care practice after surgery
Active Comparator: Enriched Surgical Management Pathway (EMP)
Enriched Surgical Management Pathway utilizing Physical Therapy and Mindfulness in addition to Standard Protocol.
Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain, Enjoyment, and General Activity Scale (PEG-3)
Time Frame: 6 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Discontinuation of Opioids After Surgery
Time Frame: 6 Months
The length of time (recorded in days) until a patient discontinues pain medications after surgery.
6 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 version 2.0
Time Frame: 6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dan Rhon

Collaborators

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

Investigators

  • Principal Investigator: Daniel I Rhon, DSc, Brooke Army Medical Center
  • Principal Investigator: Julie M Fritz, PhD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2021

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eIRB
  • 3UH3AT009763-04S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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