Non-pharmacological Treatment for Pain After Spine Surgery

Sponsor

Dan Rhon (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT04770480

Collaborator

University of Utah (Other), Madigan Army Medical Center (U.S. Fed), Tripler Army Medical Center (U.S. Fed), 59th Medical Wing (U.S. Fed), National Center for Complementary and Integrative Health (NCCIH) (NIH), Brooke Army Medical Center (U.S. Fed)

272

Enrollment

Locations

Arms

23.7

Anticipated Duration (Months)

90.7

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Chronic Pain Surgery Back Pain, Low Back Pain Lower Back Chronic	Behavioral: Standard Care (SC) Behavioral: Enriched Pain Management Pathway (EPM)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

272 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Double (Investigator, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 10, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Time to Discontinuation of Opioids After Surgery [6 Months]
The length of time (recorded in days) until a patient discontinues pain medications after surgery.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859
2	Brooke Army Medical Center	San Antonio	Texas	United States	78234
3	Madigan Army Medical Center	Tacoma	Washington	United States	98391