Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 65 years old at the time of joining the trial
• People who are able to stand for 10 minutes
• People who have had pain radiating from the lower back down into the leg (reaching below the knee), lasting at least 12 weeks, with or without lower back pain
• People who score 23 or higher on a questionnaire called the Tampa Scale of Kinesiophobia, which measures fear of movement related to pain
• People who have at least one physical examination finding that supports a diagnosis of nerve root pain in the lower back, such as: pain triggered below the knee during a straight leg raise test at 70 degrees or less; pain triggered below the knee during a Valsalva maneuver (bearing down); a positive slump test; or a nerve-related finding such as reduced sensation, muscle weakness, or reduced/absent reflexes (such as the knee or ankle reflex) in the affected area
• People with daily access to the internet through a phone, tablet, or computer
• People willing to use the Move-MORE program independently 4 to 5 times per week
• People willing to attend a two-hour virtual Zoom session once a week for eight weeks
• People willing to attend two in-person study visits and one follow-up visit
• People willing to complete 18 questionnaires about pain, quality of life, and experiences in the trial
• People willing to wear an activity-tracking wristband (actigraphy device) all day, every day — including while sleeping — for the full duration of the study, and to keep it charged
• People willing to complete a short online survey every day throughout the study
• People who can speak, read, and understand English
• People who are able to give written consent to participate
• People who rate their motivation to participate at 4 out of 10 or higher on a simple rating scale

Who may not be able to join:

• People whose nerve-related symptoms in the lower back are getting progressively worse (such as worsening loss of movement or sensation) or who have pain that is no longer tolerable
• People with signs of a condition called cauda equina syndrome, which may include: newly developed difficulty urinating or loss of bladder control not explained by another condition; loss of bowel control; new loss of sensation in the buttocks, groin, or inner thighs; or severe or worsening weakness in both legs
• People with moderate to severe foot drop — meaning noticeable weakness in lifting the front of the foot that makes walking difficult or requires a brace or support device
• People currently using a spinal cord stimulator device
• People who have received a steroid injection into the spine in the past 3 months
• People who have had surgery for lower back pain or lower back nerve pain in the past 6 months
• People who already practise mindfulness meditation at least once a week, or who have had formal training in mindfulness or meditation
• People currently diagnosed with cancer
• People with a current unmanaged or uncontrolled mental health condition known to cause psychosis, including schizophrenia, schizotypal disorders, bipolar I disorder with psychosis, or major depressive disorder with psychosis
• People diagnosed with Borderline Personality Disorder, or who score above 6 on a screening tool called the McLean Screening Instrument for Borderline Personality Disorder
• People who have started a new exercise routine or made changes to their existing one within 2 weeks before screening or enrollment
• People who have had a major medical or surgical event requiring a hospital stay (for any reason other than a minor scheduled procedure) within the past 3 months, or who have such an event planned within 5 months after joining the trial
• People currently taking part in another interventional research study, or who participated in one within 2 weeks before screening
• People whom the trial investigators believe may face increased risk by participating, for any reason (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.