Standard Care (SC)
BehavioralNo attempt will be made to change usual care practice after surgery
NCT Number: NCT04770480
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.
This study is active but is not currently recruiting participants.
18 year–75 year
All sexes
Interventional
Not applicable
Tripler Army Medical Center, Honolulu, Hawaii, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No attempt will be made to change usual care practice after surgery
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).
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.
Time frame: 6 Months
The length of time (recorded in days) until a patient discontinues pain medications after surgery.
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
Dan Rhon
Fed
Exploring Non-pharmacological Approaches to Pain Management After Lumbar Surgery: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04923334
Agnosia, Back Pain
Salt Lake City, Utah, United States
View Trial DetailsNCT04172038
Back Pain, Chronic Pain
Schofield Barracks, Hawaii, United States
View Trial DetailsNCT07641504
Back Pain, Chronic Pain
Birmingham, Alabama, United States
View Trial DetailsNCT07190807
Back Pain, Chronic Leg Pain
Greenwood, Colorado, United States
View Trial Details