A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE

Inclusion criteria

• ● Adults age 18-65 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 ≥ 23
• 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)

Exclusion criteria

• ● 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.
• 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
• 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 active mindfulness meditation practice 1 time/week or more, and/or history of formal training in mindfulness/meditation practice
• Concurrent diagnosis of cancer
• 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