Status:
ACTIVE_NOT_RECRUITING
Analysis of Crepitus in Human Subjects
Lead Sponsor:
National University of Health Sciences
Collaborating Sponsors:
Yale University
Conditions:
Low Back Pain
Healthy
Eligibility:
All Genders
30-75 years
Brief 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 pro...
Detailed Description
Objective: This is an expansion of the initial study "Analysis of Crepitus in Human Subjects" to assess the feasibility of simultaneously recording zygapophyseal (Z) joint crepitus using piezoelectric...
Eligibility Criteria
Inclusion
- 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
- 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 listed on exam form; (because these subjects will be assessed as healthy individuals, indication of somatic pathology or neurological deficit are exclusionary criteria)
- Decreased range of motion (as measured with a goniometer) of the lumbar region (recording during flexion and extension ranges of motion are conducted in the study; consequently a full range of motion is necessary for the healthy subjects). The following ranges will be exclusionary: Flexion: \< 40º (normal = 60º); Extension: \< 10º (normal = 20º);
- Pain or discomfort during set-up for lumbar side-posture spinal manipulation (SMT) or during lumbar SMT given at the conclusion of the examination (the study assesses changes following SMT, consequently ability to tolerate SMT is important)
- Contraindication to manipulative treatment
- LBP Subjects:
- Under 30 or over 75 years of age
- Absence of Current LBP of at least one-week (7 days) duration
- BMI over 30 for males; BMI over 28 for females (subject will be weighed at exam)
- Known allergies to latex or adhesives (including Band Aids) applied to the skin (accelerometers are taped to the skin)
- Pregnancy (because of unique biomechanical patterns and changes in the ranges of motion that occur during pregnancy)
- Pain radiating below the knee
- 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
- Prior spinal surgery
- Negative findings on all of the orthopedic or neurological tests listed on exam form
- Contraindication to manipulative treatment
Key Trial Info
Start Date :
September 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05425017
Start Date
September 1 2024
End Date
December 1 2025
Last Update
December 5 2024
Active Locations (2)
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1
National University of Health Sciences
Lombard, Illinois, United States, 60148
2
National University of Health Science
Lombard, Illinois, United States, 60148