Mindfulness-Oriented Recovery Enhancement in the Management of Lumbosacral Radiculopathy Symptoms: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Modified Oswestry Low Back Pain Disability Questionnaire Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
RAs recruited onto the study team to conduct study visits will not have access to information regarding participant group assignment. Study leads providing the intervention will have the opportunity to run baseline participant visits but will not be allowed to run follow-up study visits for participants in any cohort to which they have delivered an intervention. The Principal Investigator and statistician will be completely blinded to group assignments
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1: Presence of previous diagnosis of LR
- •1a: Presence of lumbosacral radiculopathy/radiculitis symptoms that extend below the knee secondary to low back pain for greater than 6 weeks with a painDETECT score greater than 18 OR.
- •1b: Diagnosis of lumbosacral radiculopathy/radiculitis secondary to low back pain that extends below the knee, with symptoms present for greater than 6 weeks.
- •1b.1: ICD-10 codes used for diagnostic inclusion: M54.16, M54.17, M51.16, M51.17, M47.26, M47.27, M54.40, M54.41, M54.42, M99.53, M99.54, S34.21, S34.22, G54.4, and G55
- •2: At least 18 years of age and not older than 64 at the time of study enrollment.
- •3: Ability to read and understand English.
- •4: Willingness to be randomized to either an experimental or a control group.
- •5: Willingness to refrain from unnecessary or self-directed pain management/treatment plan changes during study enrollment and to report necessary changes made.
- •6: Daily access to the internet via cell phone, tablet, or computer.
排除标准
- •Epidural steroid injection in the prior 3 months.
- •Inability to complete 20 unassisted gait cycles.
- •Have received a surgical intervention for low back pain or lumbosacral radiculopathy/radiculitis within the previous 6 months.
- •Current active mindfulness meditation practice: 1 time/week or more and/or formal training in mindfulness/meditation practice.
- •Concurrent diagnosis of cancer.
- •Allergy or intolerance to adhesive.
- •Current unmanaged or uncontrolled mental illness known to cause psychosis: schizophrenia and schizotypal disorders, bipolar I disorder with psychosis, major depressive disorder with psychosis.
结局指标
主要结局
Change in Modified Oswestry Low Back Pain Disability Questionnaire Score
时间窗: Change from Baseline to 8-Week Follow-Up
The ODI is designed to assess the intensity of pain and the degree to which pain interferes with activities of daily living such as personal care, lifting, walking, sitting, etc.
次要结局
- Change in SF-12 Patient Questionnaire for Quality of Life Score(Change from Baseline to 8-Week Follow-Up)
- Change in painDETECT Questionnaire Score(Change from Baseline to 8-Week Follow-Up)
- Change in Major Depression Inventory Score(Change from Baseline to 8-Week Follow-Up)
- Change in Five Facet Mindfulness Questionnaire Score(Change from Baseline to 8-Week Follow-Up)
- Change in Visual Analog Scale Score(Change from Intervention Week 1 to Intervention Week 8)
- Change in Mindful Reinterpretation of Painful Sensations Scale Score(Change from Baseline to 8-Week Follow-Up)
- Change in Surface Electromyography RMS and RMS peak time(Change from Baseline to 8-Week Follow-Up)
研究者
Katie Pickworth
Adjunct Faculty
National University of Natural Medicine