A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
The Move-MORE study is designed to evaluate a multicomponent mindfulness and movement program for patients with lumbosacral radiculopathy. The program brings together mindfulness training to help participants develop awareness of their body and manage pain-related stress, gentle movement practice to improve comfort with physical activity and support function, and motivational interviewing to strengthen motivation, confidence, and the ability to make healthy changes.
The main objectives are to determine whether it is feasible for participants to use each component of the program when delivered online, to assess how acceptable and engaging each component is, and to evaluate the impact on pain, physical function, and daily activity levels. The study intervention will be conducted entirely remotely. Participants will complete online surveys, brief daily check-ins on their phone, and wear a small activity monitor on the hip to measure movement. They will also undergo quantitative sensory testing to evaluate pain sensitivity. At the end of the program, participants will share feedback about their experiences via qualitative interviews.
The findings will help identify which parts of the program provide the greatest benefit, with the ultimate goal of developing a more targeted and effective digital program for people with this condition.
详细描述
Lumbosacral radiculopathy (LR) is a spinal pathology that manifests as pain, weakness, and numbness in the lower extremity. Commonly referred to as "sciatica", LR has a lifetime prevalence up to 43%, and can often become an intractable condition with long-term outcomes unimproved by conventional biomedical treatments such as surgery. Thus, we seek to develop a non-invasive and non-pharmacologic treatment for LR patients
This study aims to 1) develop a multicomponent intervention that integrates Mindfulness-Oriented Recovery Enhancement and physical activity for patients with LR, 2) assess the feasibility and acceptability of this multicomponent intervention, and 3) evaluate preliminary efficacy of the intervention via self-report measures of pain, disability, kinesiophobia, and other psychosocial factors related to chronic pain. In addition, this study will use quantitative sensory testing (i.e., pressure and heat pain thresholds) as an objective measure of pain.
The multicomponent intervention will be developed (AIM 1) using qualitative data from focus groups of LR patients and semi-structured interviews from a multidisciplinary sample of physicians who treat LR. This data will be analyzed using a thematic approach to assess barriers and facilitators to participation, patients' perspectives on non-pharmacologic interventions, and physicians' views of medically necessary considerations. Qualitative findings will be presented to a team of expert mindfulness instructors to support program design. In a single arm trial designed to assess feasibility, acceptability, and preliminary efficacy of the intervention (AIMS 2 and 3), we will administer the multicomponent program developed in Aim 1. Data will be collected from participants at three time points: baseline, midpoint, post-intervention, 3-month follow-up. In addition, ratings of pain intensity will be captured daily via ecologic momentary assessment.
During the intervention period, participants will be asked to attend virtual classes once a week. Between weekly sessions, participants will also be asked to track their home practice, daily levels of pain, and any adverse events via a daily survey. At the end of the study, participants will be asked to participate in a semi-structured exit interview which will inquire about their experience in the intervention.
This study seeks to shift the current research paradigm by being the first to develop and test a novel non-invasive, non-pharmacologic, multicomponent intervention for LR. As such, the proposed research contributes much needed scientific knowledge toward identifying efficacious treatments for a highly prevalent, costly, and intractable condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18-75 years at the time of enrollment
- •Ability to stand for 10 minutes
- •Presence of lumbosacral radicular pain within the past week that extends below the knee (i.e., pain radiating from the low back into the leg in a nerve root distribution) with or without accompanying low back pain, of at least 12 weeks' duration, AND
- •Tampa Scale of Kinesiophobia score ≥
- •If TSK < 23, the participant must endorse at least two of the following experiences in the past month on a structured cognitive interview:
- •Avoids movement due to fear of injury
- •Believes pain indicates harm/damage
- •Believes that movement is unsafe despite clinician reassurance
- •Reports limiting or modifying activity because of fear (not just pain)
- •At least one positive physical examination finding consistent with lumbosacral radiculopathy, including at least one of the following:
- •Positive straight leg raise test (eliciting radicular pain below the knee at ≤70 degrees of elevation);
- •Positive Valsalva maneuver (eliciting radiculcar pain below the knee);
- •Positive slump test;
- •Neurological deficit in a lumbar nerve root distribution, including at least one of the following:
- •Dermatomal sensory loss,
- •Myotomal weakness, or
- •Reduced or absent deep tendon reflexes (e.g., patellar or Achilles reflex) corresponding to the affected nerve root.
- •Daily access to the internet via cell phone, tablet, or computer
- •Willing to engage with Move-MORE 4-5 times per week on your own
- •Willing to attend a two-hour-long virtual Zoom meeting once per week for eight weeks
- •Willing to attend two in-person study visits and a follow-up visit
- •Willing to complete 18 questionnaires pertaining to your pain symptoms, quality of life, psychosocial experiences, and your experiences in the trial
- •Willing to wear an actigraphy device all day, every day, and while sleeping, for the duration of study participation and willing to keep it charged
- •Willing to respond to a daily online survey for the duration of study participation
- •Able to speak, read, and understand the English language
- •Able to provide written informed consent
- •Moderately motivated to participate as reported on a numeric rating scale (≥ 4/10)
排除标准
- •Participants will be excluded if they have clinical signs or symptoms of lumbosacral radiculopathy with progressive neurologic deficits (loss of motor or sensory function) or intolerable pain.
- •o Participants with lumbosacral radiculopathy with progressive neurologic deficits will be referred for immediate medical attention, and are not eligible for participation in this study.
- •Participants will be excluded if they have clinical signs or symptoms suggestive of cauda equina syndrome, including any of the following:
- •New-onset urinary retention or overflow incontinence not attributable to other known causes;
- •Fecal incontinence;
- •New onset of saddle anesthesia (loss of sensation in the buttocks, perineum, and inner thighs);
- •Severe or progressive bilateral lower extremity weakness; ▪ Participants with suspected cauda equina syndrome will be referred for immediate medical attention, and are not eligible for participation in this study.
- •Presence of moderate to severe foot drop, defined as noticeable weakness in ankle dorsiflexion that interferes with walking or requires the use of an assistive device (e.g., ankle-foot orthosis). Participants with suspected or worsening foot drop will be referred for further evaluation and are not eligible for study participation.
- •Current use of a spinal cord stimulator. Individuals with an implanted spinal cord stimulator may be eligible if the device has been deactivated for at least 4 weeks prior to enrollment and the participant agrees to keep the device deactivated for the duration of study enrollment, unless reactivation is medically necessary. Individuals who reactivate spinal cord stimulation during the intervention period may be withdrawn from the study.
- •Have received a lumbosacral nerve ablation in the prior 3 months
- •Have received epidural steroid injection in the prior 3 months
- •Have received a surgical intervention for low back pain or lumbosacral radiculopathy in the previous 6 months
- •Current regular mindfulness meditation practice, defined as formal seated, lying, or walking meditation practiced at least once per week for the past 4 weeks or longer, and/or a history of substantial formal mindfulness or meditation training (e.g., completion of a structured mindfulness-based program, meditation retreat, or equivalent training). Casual awareness of breathing, brief relaxation exercises, prayer, yoga without meditation, general stress-management strategies, or mindful awareness during routine activities do not meet this exclusion criterion unless they are part of a regular formal mindfulness meditation practice.
- •Active malignancy requiring ongoing systemic treatment (e.g., chemotherapy, immunotherapy, targeted therapy, or radiation therapy), or malignancy that, in the judgment of the Principal Investigator or Clinical Investigator, may interfere with study participation, increase participant risk, or plausibly explain the participant's lumbosacral radicular pain. Participants with a history of cancer that has been treated and is currently stable, in remission, or under routine surveillance are eligible. Localized non-melanoma skin cancers (e.g., basal cell carcinoma or squamous cell carcinoma) do not meet this exclusion criterion unless they are expected to interfere with study participation.
- •Current unmanaged or uncontrolled mental illness known to cause psychosis: schizophrenia, schizotypal disorders, bipolar I disorder with psychosis, major depressive disorder with psychosis
- •Diagnosis of Borderline Personality Disorder or score >6 on the McLean Screening Instrument for Borderline Personality Disorder
- •Initiation of or changes to an exercise regimen within 2 weeks prior to screening and/or enrollment
- •Major medical or surgical event requiring hospitalization (for any reason other than a minor scheduled medical procedure) within 3 months prior to screening; or, scheduled or will be scheduled to occur within the 20 weeks (i.e., five months) after enrollment
- •Currently participating in another interventional research study or participated in another interventional study within 2 weeks prior to screening
- •Any reason the Clinical Investigator or Principal Investigator believes confers increased risk to the potential participant, if they were to enroll in the study
研究组 & 干预措施
Treatment
Participants will go through the multicomponent Move-MORE program. Move-MORE is an integrated mind-body intervention which combines mindfulness, physical activity, and motivational interviewing informed by the principles of self-determination theory
干预措施: Move-MORE (Behavioral)
结局指标
主要结局
Oswestry Disability Index
时间窗: Week 0, Week 4, Week 8, Week 20
Activities of daily living. Min = 0%, Max = 100%. Higher score = worse outcomes.
Oswestry Disability Index
时间窗: Week 0, Week 4, Week 8, Week 20
Activities of daily living. Min = 0%, Max = 100%. Higher score = worse outcomes.
Recruitment Proportion
时间窗: End of study
The proportion of patients contacted who consent to screening
Retention
时间窗: End of study
Retention will be assessed by tracking the percentage of participants who complete their primary endpoint visit
Client Satisfaction Questionnaire
时间窗: Week 4, Week 8, Week 20
Intervention Satisfaction. Min = 8, Max = 32. Higher score = greater satisfaction.
Adherence
时间窗: End of study
The proportion of participants completing at least 5 intervention sessions
Adverse Events
时间窗: End of study
The frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring during the study.
Intervention Satisfaction
时间窗: Week 4, Week 8
Satisfaction will be measured using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is a self-report measure designed to assess satisfaction with health services.
次要结局
- painDETECT Questionnaire(Week 0, Week 4, Week 8, Week 20)
- Client Satisfaction Questionnaire(Week 4, Week 8, Week 20)
- painDETECT Questionnaire(Week 0, Week 4, Week 8, Week 20)
- Client Satisfaction Questionnaire(Week 4, Week 8, Week 20)
- Visual Analog Scale(Daily)
- Oswestry Disability Index(Week 0, Week 4, Week 8, Week 20)
- Complex Medical Symptoms Inventory(Week 0, Week 4, Week 8, Week 20)
- Nociplastic Pain Questionnaire(Week 0, Week 4, Week 8, Week 20)
- Patient Global Impression of Change(Week 0, Week 4, Week 8, Week 20)
- Healthcare Utilization Changes(Week 4, Week 8, Week 20)
- The Pain, Enjoyment of Life and General Activity (PEG-3)(Week 0, Week 4, Week 8, Week 20)
- Tampa Scale of Kinesiophobia (TSK-11)(Week 0, Week 4, Week 8, Week 20)
- Pain Catastrophizing Scale (PCS)(Week 0, Week 4, Week 8, Week 20)
- PROMIS Self-Efficacy for Managing Symptoms 8a(Week 0, Week 4, Week 8, Week 20)
- PROMIS Ability to Participate in Social Roles(Week 0, Week 4, Week 8, Week 20)
- PROMIS Sleep Disturbance 6a + Sleep Duration Question(Week 0, Week 4, Week 8, Week 20)
- Whole Person Health Index (WPHI)(Week 0, Week 4, Week 8, Week 20)
- Patients Endorsement of a Biopsychosocial Model of Chronic Pain Scale (PEB)(Week 0, Week 4, Week 8, Week 20)
- World Health Organization Quality of Life Questionnaire - 2 (WHOQOL-2)(Week 0, Week 4, Week 8, Week 20)
- Patient Health Questionnaire - 8 (PHQ-8)(Week 0, Week 4, Week 8, Week 20)
- Generalized Anxiety Questionnaire-7 (GAD-7)(Week 0, Week 4, Week 8, Week 20)
- Treatment Self-Regulation Questionnaire (TSRQ)(Week 0, Week 4, Week 8, Week 20)
- International Physical Activity Questionnaire (IPAQ)(Week 0, Week 4, Week 8, Week 20)
- Five Facet Mindfulness Questionnaire (FFMQ)(Week 0, Week 4, Week 8, Week 20)
- Mindful Reappraisal of Pain Scale (MRPS)(Week 0, Week 4, Week 8, Week 20)
- Multidimensional Assessment of Interceptive Awareness - Version 2 (MAIA-2)(Week 0, Week 4, Week 8, Week 20)
- Purpose in Life Scale(Week 0, Week 4, Week 8, Week 20)
- PROMIS Physical Functioning Short Form 6b(Week 0, Week 4, Week 8, Week 20)
研究者
Ryan Wexler
Assistant Research Investigator
National University of Natural Medicine