Analysis of Crepitus in Human Subjects

NCT05425017 | Active Not Recruiting

• 1 other identifier: H2101/H2302
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Low Back Pain; Healthy

Keywords

crepitus; spine; noise; physiological; pathological

Outcome Measures

Primary Outcomes (2)

• Inter-rater reliability of analysis of spinal crepitus produced during range of motion

  Piezoelectric accelerometers are taped to the participants spine. The participant then completes a range of motions while the accelerometers are recording any sounds being produced during the movement. Following range of motion, the participant receives a side posture chiropractic adjustment and then repeats the range of motion while the accelerometers are recording. All participant recordings will be collected prior to the start of analysis. Utilizing previously validated methods to analyze accelerometer recordings taken during participants range of motion, spinal crepitus will be identified and defined and programmed into a computer automated method of analysis. Kappa inter-rater reliability statistic will be compare consensus of two human observers to the computer automated method of analysis will be compared.

  6 month following data collection

• Time of analysis of spinal crepitus produced during range of motion

  Piezoelectric accelerometers are taped to the participants spine. The participant then completes a range of motions while the accelerometers are recording any sounds being produced during the movement. Following range of motion, the participant receives a side posture chiropractic adjustment and then repeats the range of motion while the accelerometers are recording. All participant recordings will be collected prior to the start of analysis. Utilizing previously validated methods to analyze accelerometer recordings taken during participants range of motion, spinal crepitus will be identified and defined and programmed into a computer automated method of analysis. The time it takes to complete analysis of all crepitus recordings will be compared by ANOVA between two human observers and the computer automated method of analysi

  6 month following data collection

Secondary Outcomes (1)

• Change in crepitus following spinal manipulation

  6 month following data collection

Study Arms (2)

Low back pain group

Participants currently experiencing low back pain will have small accelerometers taped along spine, Ultrasound (US) Clinician will place an US transducer at the right L4/L5 Z joint. Participants will complete a range of motions while accelerometers are recording back sounds. Subsequently, they will receive a chiropractic adjustment, then repeat the range of motions

Other: Range of motion with spinal adjustment

Healthy group

Participants without low back pain will have small accelerometers taped along spine. Ultrasound (US) Clinician will place a US transducer at the right L4/L5 Z joint. Participants will perform a range of motions while accelerometers are recording back sounds. Subsequently, they will receive a chiropractic adjustment, then repeat the range of motions

Other: Range of motion with spinal adjustment

Interventions

Range of motion with spinal adjustment OTHER

With accelerometers affixed to spine recording vibrations, the participants complete range of motion. After completing, they receive a low back spinal adjustment and repeat range of motion

Healthy group; Low back pain group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the faculty, student and staff population at National University Of Health Sciences, Lombard, IL. If unable to recruit sufficient number of participants, recruitment will be extended to the general population of the Chicago, IL metro area.

You may qualify if:

• Healthy (no LBP) Subjects (n=6):
• 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):
• 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.

You may not qualify if:

• Healthy Subjects:
• Under 30 or over 75 years of age
• 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)
• 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)

Sponsors & Collaborators

• National University of Health Sciences: lead
• Yale University: collaborator

Study Sites (2)

National University of Health Sciences

Lombard, Illinois, 60148, United States

Location

National University of Health Science

Lombard, Illinois, 60148, United States

Location

Related Publications (19)

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  RESULT

MeSH Terms

Conditions

Low Back Pain

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gregory Cramer, DC, PhD

  National University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Gregory Roytman, DC

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Dean of Research

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: September 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-11

Locations

US (2)