ACTIVE_NOT_RECRUITING

Non-pharmacological Treatment for Pain After Spine Surgery

Conditions

Low Back Pain Chronic Pain Surgery Back Pain, Low Back Pain Lower Back Chronic spine surgery non-pharmacological treatment mindfulness physical therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-12-10

Study Completion:2026-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04770480

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Principal Investigator

Julie M Fritz, PhD

PRINCIPAL_INVESTIGATOR

University of Utah

Daniel I Rhon, DSc

PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Study Locations (Sites)

Tripler Army Medical Center

Honolulu, Hawaii, 96859

United States

Brooke Army Medical Center

San Antonio, Texas, 78234

United States

Madigan Army Medical Center

Tacoma, Washington, 98391

United States

Collaborators and Investigators

Sponsor: Dan Rhon

Julie M Fritz, PhD, PRINCIPAL_INVESTIGATOR, University of Utah
Daniel I Rhon, DSc, PRINCIPAL_INVESTIGATOR, Brooke Army Medical Center

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 Registration Dates

Study Start Date2021-12-10

Study Completion Date2026-03-30

Study Record Updates

Study Start Date2021-12-10

Study Completion Date2026-03-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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