MORE in the Management of Lumbosacral Radiculopathy Symptoms: A Randomized Controlled Trial — MORE  

Lumbar Radiculopathy Clinical Trial

Official title: Mindfulness-Oriented Recovery Enhancement in the Management of Lumbosacral Radiculopathy Symptoms: A Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

INTRODUCTION: Chronic low back pain (CLBP) is a ubiquitous musculoskeletal (MSK) complaint that often presents as a chronic and difficult to treat condition. Lumbosacral radiculopathy/radiculitis (LR) or "sciatica" is a common secondary condition that can last well beyond the expected time frame after treatment with physical therapy, oral anti-inflammatory medications, local steroidal injections, and surgery. Challenges in the treatment of LR indicate that persistent pain may have evolved from mechanical to neuropathic. Previous research has shown that, in addition to the aforementioned treatments, mindfulness-based stress reduction (MBSR) is effective in limiting self-reported pain in patients with CLBP and neurogenic conditions such as fibromyalgia. This study proposes a randomized clinical trial to evaluate the effects of a newer mindfulness program, Mindfulness Oriented Recovery Enhancement (MORE), on self-reported pain, physical function, quality of life (QoL), depression symptoms, trait mindfulness, reinterpretation of pain, and surface electromyography (sEMG) findings in patients with LR.

METHODS: Participants will be recruited from the Portland, OR metro area. Upon screening and recruitment, participants will receive a battery of questionnaires collecting demographic, self-reported pain, physical function, QoL, depression symptoms, mindfulness, and reinterpretation of pain data. Participants will also undergo sEMG to identify neurological abnormalities that can be characterized diagnostically. Upon enrollment, participants will be randomized to either the mindfulness-based intervention group (MBI), MORE; or the control group, treatment as usual (TAU), for 8 weeks. Self-reported pain measures and sEMG studies will be conducted again at eight weeks post randomization.

HYPOTHESES: Primarily, investigators hypothesize that MORE will be effective in improving self-reported pain, physical function, QoL, depression symptoms, mindfulness, and reinterpretation of pain scores after eight weeks of mindfulness training. Secondarily, investigators hypothesize that those individuals with abnormal sEMG findings at baseline will have improved sEMG findings at their eight-week follow-up visit.

ANALYSIS PLAN: Changes in self-reported pain, physical function, QoL, depression symptoms, trait mindfulness, and reinterpretation of pain will be analyzed using descriptive statistics as well as ANCOVA. Regression will also be used to evaluate the dose-response relationship between all outcome measures and time spent in mindfulness practice for the intervention group. Finally, ANCOVA will be used to evaluate the relationship between pain and physical function and sEMG findings.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

• NCT number: NCT04818606
• Study type: Interventional
• Source: National University of Natural Medicine
• Contact: Ryan Wexler, BS
• Phone: 503-552-1836
• Email: MOREstudy@nunm.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Completion date: March 2022