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Analysis of Crepitus in Human Subjects

Low Back Pain · Healthy

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
Observacional
Fase
No aplica / no indicada
Rango de edad
30 años - 75 años
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
12 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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 accelerometers and Z joint motion using diagnostic ultrasound (US), and qualitatively assess the US images with particular focus on images taken of Z joints exhibiting crepitus. Like the original study (n=12), the results of a recently developed automated method (AM) is compared with two human observers in the analysis of recordings of human lumbar zygapophyseal (Z) joint crepitus. The recordings will be taken during ranges of motion performed before and after lumbar side-posture spinal manipulation (SMT). Methods: Six (6) healthy and 6 low back pain subjects will participate in the study. Using clinical study procedures developed previously, subjects will be given an initial phone screen before being scheduled for a clinical study appointment. At the appointment, subjects will undergo the informed consent process, and those consenting will be further screened and examined by the Research Clinician who will use the inclusion/exclusion criteria to determine eligibility for the study. Eligible subjects will be enrolled and scheduled for an accelerometry visit. At the accelerometry visit, 11 accelerometers will be applied to the lumbar region, allowing assessment of Z joint crepitus. US imaging of the right L4/L5 Z joint will be included. Each subject will undergo full flexion and full extension (ROM) while recordings are made from the accelerometers. Subjects will then undergo bilateral lumbar SMT, and immediately thereafter will undergo repeated ROM while recordings are made. Two human observers and the AM, blinded to the results of one another, will then assess the recordings to identify Z joints from which crepitus originated. The primary outcomes will be: 1) weighted kappa inter-rater reliability statistic comparing AM and the 2 human observers in identifying Z joint crepitus, and 2) ANOVA test statistic comparing time to complete the crepitus analysis by the AM and human observers. Hypotheses: 1) The automated method will be reliable, agreeing with the human observers' analysis. 2) The automated method will be significantly more time efficient than the analyses made by the human observers. Application: The investigators believe that this program will improve the efficiency of identifying the site of Z joint crepitus, thereby advancing the line of investigation designed to use crepitus as a biomarker of spinal joint dysfunction.

¿Quién podría participar?

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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 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

Población del estudio

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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación
No informado
Enmascaramiento
No informado
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

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

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

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

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

Plazo: 6 month following data collection

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.

Time of analysis of spinal crepitus produced during range of motion

Plazo: 6 month following data collection

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

Medidas secundarias

Change in crepitus following spinal manipulation

Plazo: 6 month following data collection

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. For each participant, crepitus produced during range of motion performed prior to chiropractic adjustment will be compared to crepitus produced following chiropractic adjustment. All participant recordings will be collected prior to the start of analysis. Ultrasound outcomes will be subjective and descriptive to identify imaging of the right L4/L5 Z joint.

El registro no indica resultados publicados.

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Centros de investigación (3)

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3 centros

National University of Health SciencesLombard, Illinois, United StatesEstado desconocido
National University of Health ScienceLombard, Illinois, United StatesEstado desconocido
Jocelyn Faydenko, ND, DCCONTACTjfaydenko@nuhs.edu6308896420
Gregory Cramer, DC, PhDCONTACTgcramer@nuhs.edu6308896536
Gregory Cramer, DC, PhDPRINCIPAL_INVESTIGATOR
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National University of Health ScienceLombard, Illinois, United StatesEstado desconocido

Equipo y fechas

Patrocinador principal
National University of Health Sciences
Inicio del estudio
1 dic 2026 Estimado
Finalización primaria
2027-12 Estimado
Finalización del estudio
1 jun 2028 Estimado
Primera publicación
21 jun 2022 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Jocelyn Faydenko, ND, DCCONTACTjfaydenko@nuhs.edu630-889-6849
Gregory Cramer, DC, PhDCONTACTgcramer@nuhs.edu630-889-6849
Título oficial del estudio

Simultaneous Crepitus and Diagnostic Ultrasound Assessment of the Lumbar Zygapophyseal Joints Expansion of Validation and Reliability of Automated Analysis of Crepitus in Human Subjects

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026