Innovative Imaging of Cerebrum and Muscle (iCAM) Repeatability Study

Completed

Conditions studied: Low Back Pain, Aging

In brief

Impairments in postural control are linked to low back pain and reductions in physical function in the elderly. Unfortunately, many techniques to assess the neural control of movement are not feasible, or directly applicable, to the trunk musculature. In a prior pilot study, we developed and optimized innovative approaches to study these muscles. We will continue to develop a reliable, fMRI protocol that investigates the activity of the motor cortical networks of selected trunk muscles (specific aim 1). We will also continue the development a reliable muscle functional MRI (mfMRI) protocol to assess the spatial muscle activation patterns of the deeper lumbopelvic muscles (specific aim 2). We will examine the test-retest reliability of these approaches in four distinct target populations: healthy adults, adults with chronic low back pain, older adults, and older adults with high levels of trunk muscle control (i.e., individuals with expertise in Pilates). By enrolling groups of various levels of trunk muscle control, pathology state and age, we will be able to not only determine the intra-individual reliability, but also the inter-individual reliability as we expect the variability of the measures to be influenced by physical ability, pain state and age. Lastly, in an exploratory aim we will examine the association of our novel neurophysiological measures from Aim 1 and 2 with classic biomechanical and muscle function measures (e.g., trunk extensor strength and trunk extensor steadiness). Successfully developing reliable techniques of this nature will result in new and improved research tools for conducting rigorous studies of therapeutic approaches, such as spinal manipulation and yoga, within the context of trunk muscle control and function.

Key facts

Study ID

NCT03548168

Run by

Ohio University

People needed

28

Starts

2018-05-18

Expected to finish

2020-05-05

Last updated by the study team

2021-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A subject must meet the following criteria to be eligible for inclusion in the study:
• Men and women aged 18- 30 years, with no significant health issues or conditions that, in the investigator's opinion, would limit the subject's ability to complete the study activities or that would impact the capability to get an accurate measurement of study endpoints.
• Body mass index (BMI) between 17 and 30 kg/m2.
• Willing to undergo multiple MRI sessions.
• Willing and able to return for all visits and complete all study-related activities.
• Able to read, understand, and complete study-related questionnaires
• Able to read and understand, and willing to sign the informed consent form (ICF).

You may not qualify if…

• A subject who meets any of the following criteria will be excluded from the study:
• Having body dimensions that exceed the MRI or exercise equipment limits.
• Unable to undergo MRI (e. g. body containing any metallic medical devices or equipment, including heart pacemakers, metal prostheses, implants or surgical clips, any prior injury from shrapnel or grinding metal, exposure to metallic dusts, metallic shavings or having tattoos containing metallic dyes)
• Abnormal or uncontrolled blood pressure at the screening visit defined as BP > 180/100 mmHg.
• Positive pregnancy test.
• Having a personal history of the following neurological disorders: Alzheimers, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinsons, Stroke
• Having a personal history of the following cardiorespiratory disorders: Congestive heart failure, Heart attack in past 24 months
• Having a personal history of the following musculoskeletal disorders: Rheumatoid Arthritis, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis. Including a history of spine surgery or a hip arthroplasty.
• Having neurological symptoms (ie. burning, numbness, tingling sensations into the legs), muscle weakness associated with neural dysfunction (i.e. foot drop), or episodes of incontinence of bowel or bladder.
• Having active cancer
• Blindness
• Having used opioids or muscle relaxants within 30 days prior to study enrollment.
• Reports being pregnant, lactating, or that they anticipate becoming pregnant in the next 3-months. If a woman becomes pregnant while on study protocol they will be withdrawn from the study.
• Reports unexplained weight loss over the past month (greater than 10 lbs).
• Failure to provide informed consent.
• Young adults with chronic low back pain (CLBP) Eligible subjects are males and females aged 18- 30 years with no significant health issues except self report of CLBP
• Inclusion Criteria:
• A subject must meet the following criteria to be eligible for inclusion in the study:
• Men and women aged 18- 30 years, with no significant health issues or conditions that, in the investigator's opinion, would limit the subject's ability to complete the study activities or that would impact the capability to get an accurate measurement of study endpoints.
• Body mass index (BMI) between 17 and 30 kg/m2.
• Willing to undergo multiple MRI sessions.
• Willing and able to return for all visits and complete all study-related activities.
• Able to read, understand, and complete study-related questionnaires.
• Able to read and understand, and willing to sign the informed consent form (ICF).
• Reports average pain intensity (assessed using the Numerical Pain Rating (NPRS) scale) over the past week greater than or equal to 3 on a 0-10 numerical pain scale.

Where it is running

• Ohio Musculoskeletal and Neurological Institute (OMNI) at Ohio University — Athens, Ohio, United States

Full record on ClinicalTrials.gov

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