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Investigation of Gait Measures Collected from a Novel Sensor Device for Healthy Participants and Participants with Chronic Lower Back Pain and Knee Osteoarthritis

Trial ID: CBP-00000003

Trial Description

Eli Lilly and Company (the study sponsor) is evaluating the link between patient-reported pain scales and gait (the way that someone walks) as collected from a shoe insole device. While doctors have some options to treat and manage chronic low back and knee pain, many people still do not have adequate pain control and have problems with their daily functioning because of their pain, and more research is needed to better understand this public health problem. This study will enroll 175 adult participants. Some will not have a medical condition, and some will have osteoarthritis or chronic back pain. This trial will last approximately 8 weeks and will not have any drug or medicine involved. The study will be conducted virtually, and participants can complete all study tasks at home.

Estimated Enrollment

175 Participants

Phase

N/A: Trial does not have a phase

Eligibility Criteria

Participants must:

  • Be at least 18 years old
  • Have been diagnosed by a physician with a musculoskeletal condition (degenerative joint disease, degenerative disc disease, chronic muscle pain, lumbar spinal stenosis) causing low back pain for at least 3 months located between the 12th thoracic vertebra (width of a hand above waistline to tail bone) and the lower gluteal folds
  • Be capable of providing informed consent and carrying out all study activities and assessments

Participants must not:

  • have any of the following medical conditions:
    • fibromyalgia
    • chronic pain syndrome
    • rheumatoid arthritis
    • psoriatic arthritis
    • ankylosing spondylitis
    • arthritis associated with inflammatory bowel disease
    • sarcoidosis
    • amyloidosis
    • history of gout
    • history of pseudogout
    • had a recent major trauma (within 6 months)
    • using a spinal cord stimulator or dorsal root ganglion stimulator
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Site Locations

This study is completely virtual and all study assessments can be conducted at home. There are no clinic visits.

What Will Happen In This Study

In this study, participants will be screened and enrolled into the study online.

All study activities will be done virtually over approximately 8 weeks.

Eligible participants will be sent all the study kit materials which include a wrist-worn actigraphy device, FeetMe shoe insoles, a smartphone with the FeetMe Research App, and charging cab les for both the insoles and smartphone.

Participants will wear the actigraphy device on the wrist throughout the entire study and will wear the shoe insoles for at least 2 hours every day.

Participants in the study will answer online a daily question on pain level and several brief questionnaires related to pain, physical functioning and sleep every 2 weeks throughout the study. Information collected from these questionnaires, the wrist-worn actigraphy device, and the shoe insole devices may provide new information into the pain condition .

Frequently Asked Questions (FAQs)