Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-25 @ 5:12 AM
NCT ID:
NCT07125027
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
66 Years
Study:
NCT07125027
Study Brief:
Protocol Section:
NCT07125027