Non-pharmacological Treatment for Pain After Spine Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Back Pain Lower Back Chronic
- Back Pain, Low
- Chronic Pain
- Low Back Pain
- Surgery
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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: 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
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04770480
- 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
- Investigators
- Principal Investigator: Julie M Fritz, PhD University of Utah Principal Investigator: Daniel I Rhon, DSc Brooke Army Medical Center
Get Well Soon