Analysis of Crepitus in Human Subjects (NCT05425017) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Analysis of Crepitus in Human Subjects
United States12 participantsStarted 2024-09-01
Plain-language summary
Chiropractic adjustment has been shown to gap certain joints in the spine, thereby improving mobility in individuals with decreased movement capabilities. During normal motion, joints in the spine produce sounds and vibrations called crepitus. The purpose of this study is to assess how this crepitus may be used as an indicator for joint degeneration in healthy human subjects and those with low back pain, and if chiropractic adjusting causes change in this crepitus. The investigators hypothesize that change in crepitus after adjustment may be a useful indication of changes in joint mobility and joint stiffness.
Who can participate
Age range
30 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Healthy (no LBP) Subjects (n=6):
* 30 to 75 years of age
* No previous history of LBP lasting for more than two weeks, or no more than three episodes of back pain of brief duration (one week) in any given year (to recruit healthy subjects with no history, or a minimal history, of LBP).
* No presence of current LBP
* Female with a BMI of 28 or less; Male with a BMI of 30 or less.
LBP Subjects Criteria (n=6):
* 30 to 75 years of age
* Current LBP of at least one-week (7 days) duration
* Female with a BMI of 28 or less; Male with a BMI of 30 or less.
Exclusion Criteria:
Healthy Subjects:
* Under 30 or over 75 years of age
* History of an episode of LBP lasting for more than two weeks, or more than three episodes of back pain of brief duration (one week) in any given year (see reasons for no LBP in Inclusion Criteria)
* Presence of Current LBP
* Prior spinal surgery
* Presence of current spinal fracture, tumor, infection, or scoliosis of greater than 5 degrees (Cobb's angle, scoliosis decreases ability to place the accelerometers); or other known significant pathology
* Known allergies to latex or adhesives (including Band-Aids) applied to the skin (accelerometers are taped to the skin)
* BMI over 30 for males; BMI over 28 for females (subject will be weighed at exam)
* Pregnancy (because of unique biomechanical patterns and changes in the ranges of motion that occur during pregnancy)
* Positive findings on any of the orthopedic or neurological tests li…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Inter-rater reliability of analysis of spinal crepitus produced during range of motion
Timeframe: 6 month following data collection
2
Time of analysis of spinal crepitus produced during range of motion