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Assessing Tissue Response to High-Velocity Thrust Manipulations on Capsule Length and Stiffness at the C5-C6 Facet Joint Capsule

24. august 2026 oppdatert av: Florida Gulf Coast University

Assessing Tissue Response to High-Velocity Thrust Manipulations: Measuring Lasting Changes in C5-C6 Facet Joint Capsule Length With Musculoskeletal Ultrasound and Stiffness With Elastography

This study is a quasi-experimental study collected quantitative data , with a pre-test-post-test design. Pre-intervention, baseline measurements of C5-C6 right facet joint length and width with the head of the treatment plinth downward at 45 and 90 degrees, (relative to the rest of the table) and stiffness at 90 degrees, were taken prior to applying the long-axis thrust manipulation. Post-intervention measures were taken immediately after a long axis thrust manipulation of C5-C6 and again at 24-hours after the manipulation. The baseline pre-intervention measures were then compared to the post-intervention measurements. The investigator performing the manipulation was blinded to the quantitative measurements of the ultrasound images. The ultrasound operator was blinded to the outcome of the manipulation.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

The study takes place in Marieb Hall rooms 101 and 103 of Florida Gulf Coast University. After meeting the inclusion and exclusion criteria subjects sign the informed consent form described thoroughly on the following page. The participants undergo three recording sessions on two consecutive days. The first recording session consist of obtaining participant consent and general information, such as height and weight. The participants then has their baseline measures cervical flexion ROM, capsular length and width at both 45 and 90 degrees, and stiffness at 90 degrees, taken. The second and third session consist only of repeating these baseline measures post-manipulation and 24-hours post-manipulation respectively. Each participant will be provided a profile on the ultrasound unit, corresponding to their subject number, with each point in time having an individual exam within the profile. At these sessions, recordings are done in the prone position to measure length of the C5-C6 joint capsule and joint capsule tissue extensibility. Locating the articular pillar was a three-fold process. At the intervention table, the C7 spinous process is identified in upright sitting with palpation, due to its relevance in clinical examination and evaluation, serving as the first landmark. From this position, one of the measuring practitioners moves their finger cranially to the C6 spinous process. The participant's head is moved passively into extension, causing the spinous process to move away from the practitioner's finger, providing further confidence in location accurary. This landmark isthen marked for repeatability. The participant then has their cervical flexion range of motion measured with a fluid-filled inclinometer. A fluid-filled inclinometer utilizes gravity to quantify gross motion. This method is easily repeated and validated for clinical measurements. Each participant is given the instructions, "sit up straight and tuck your chin to your chest." At the ultrasound table, a goniometer is secured with the stationary arm in line with the table, the axis through the pivot point for the head of the table, and the moving line in line with the head of the table.

The participant is then instructed to lie prone on the table, with the head of the table positioned at 45 degrees. Anytime the head position of the table is altered, two researchers confirmed the angle of the goniometer. The 45 degree angle was selected to neutralize the natural lordosis of the lower cervical spine. The table insert is removed for the participant's face to lie within the opening. A piece of tape is placed at the base of the table opening . The participants are given the instructions, "tuck your chin and put the front of your chin on the piece of tape." From this point, the ultrasound probe is placed in a right paramedian sagittal/long-axis view. The probe was angled 15 degrees from lateral-to-medial in the posterior-to-anterior direction.

Beginning at the occipital bone, the probe is moved inferiorly. The articular pillar is known to have a jagged, sawtooth like appearance when observed from this angle. The trough at the bottom of the sawtooth indicates the inferior articular process of the cranial vertebra, while the following peak will be depicting the superior articular process of the following caudal vertebra.

This allowed the practitioners to count the peaks observed and identify the spinal levels visualized on the screen. The mark placed on the C6 spinous process is compared to probe location once the C6 level has been visualized on the screen. After the level is confirmed to be correct, the probe remained stationary on the participant. Once the correct level is visualized, the first screen capture video was taken and saved to the participant exam. The head of the table is then angled fully down towards the floor, measured at 90 degrees with the secured goniometer. By having the head of the table as far down as it allows, the process for achieving full cervical flexion remained standardized. This is also confirmed via palpation of the interspinous space of T1 and by both practitioners audibly confirming the observation of the thoracic spine flexion, indicating full cervical flexion is achieved. While the capsule could theoretically be put under more tension by utilizing multiplanar movements, utilizing only flexion offers a standardized, repeatable method that is less susceptible to confounding variables. As the probe remains stationary with the C5-C6 joint in view, the second screen capture video is taken. While remaining in the fully flexed position, the ultrasound operator start the elastography on the ultrasound unit. Once displayed on screen, a third screen capture video is taken.

The participant then returns to the initial table to receive the intervention. The practitioner performing the HVLA long axis C6-C6 manipulation on the right stands at the head of the plinth, on the right side of the patient positioned in supine. The practitioner's right hand is placed under C6, while the left hand is placed under the chin as the arm cradles the head. Using the left hand and arm, the practitioner passively rotated the head away and side-bent the head toward the targeted side. Once end-range motion is achieved, the practitioner provides a high-velocity low-amplitude long-axis thrust in a superior direction, parallel to the angle of the targeted segment.

Following the manipulation, the participant has their cervical range of motion re-measured, and the ultrasound imaging process is repeated in a new exam. Once the immediate post-intervention measures are taken, the subjects are instructed to come back for a third imaging session at the exact same time the following day. At the 24-hour follow-up, the participants cervical flexion range of motion is repeated, as well as the three ultrasound procedures.

Studietype

Intervensjonell

Registrering (Faktiske)

42

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Florida
      • Fort Myers, Florida, Forente stater, 33965
        • Florida Gulf Coast University Marieb Hall 101

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Healthy individuals between 18-35 without neck pain
  • Able to to read and understand English

Exclusion Criteria:

  • autoimmune disease
  • down syndrome
  • fusion, fracture
  • spinal cord compression
  • vascular pathology
  • cancer,
  • any other conditions that induce severe instability
  • inflammation
  • weakened bone.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Sample
C5-C6 long axis joint manipulation
Long axis trust manipulation C5-C6

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
facet capsule length and width
Tidsramme: before intervention, immediately after, and at 24 hour follow up
MSK US measure facet length and with in mm
before intervention, immediately after, and at 24 hour follow up

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cervical motion
Tidsramme: before intervention, immediately after, and at 24 hour follow up
Max neck flexion motion in sitting measured in degrees
before intervention, immediately after, and at 24 hour follow up
elastography
Tidsramme: Before intervention, immediately after, and 24 hours after
tissue pliability assessment with MSK US
Before intervention, immediately after, and 24 hours after

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

  • 1. Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The global spine care initiative: a summary of the global burden of low back and neck pain studies. Euro Spine Journ. 2018;27(1):796-801. 2. Brown S. Distracted doctoring. Springer Cham; 2017 3. Herzog W. The biomechanics of spinal manipulation. Journ Body and Move Ther. 2010;14(3):280-286. https://doi.org/10.1016/j.jbmt.2010.03.004 4. Olson KA. Manual Physical Therapy of the Spine. Elsevier - Health Science; 2021. 5. Pettman E. A history of manipulative therapy. Journ of Man & Manip Ther. 2007;15(3):165-174. https://doi.org/10.1179/106698107790819873 6. Giacalone A, Febbi M, Magnifica F, Ruberti E. The effect of high velocity low amplitude cervical manipulations on the musculoskeletal system: literature review. Cureus. 2020;12(4). doi: 10.7759/cureus.7682 7. Young IA, Pozzi F, Dunning J, Linkonis R, Michener LA. Immediate and short-term effects of thoracic spine manipulation in patients with cervical radiculopathy: a randomized controlled trial. JOSPT. 2019;49(5):299-309. doi: 10.2519/jospt.2019.8150 8. Reggars JW. The manipulative crack. Journ Chiro Osteo Coll of Aust. 1996;5(2):39-44. doi: 9. Manning A, Butts R, Dunning J. Audible pop during spinal manipulation: plausible mechanisms and clinical relevance. AAMT. June 21, 2016. Accessed October 14, 2024. https://spinalmanipulation.org/2016/06/21/audible-popping-during-spinal-manipulation-plausible-mechanisms-and-clinical-relevance/ 10. Moorman AC. Impact of audible pops associated with spinal manipulation on perceived pain; a systematic review. Chiro and Manual Ther. 2022;30(1). https://doi.org/10.1186/s12998-022-00454-0 11. Smith J, Finnoff JT. Diagnostic and interventional musculoskeletal ultrasound: Part 1. fundamentals. PM&R. 2009;1(1):64-75. https://doi.org/10.1016/j.pmrj.2008.09.001 12. Moreno B, Barbosa J. Ultrasound-guided procedures in the cervical spine. Cureus. 2021. https://doi.org/10.7759/cureus.20361 13. Vasiliadis ES, Grivas TB, Kaspiris A. Histo

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. februar 2025

Primær fullføring (Faktiske)

1. juni 2026

Studiet fullført (Faktiske)

1. august 2026

Datoer for studieregistrering

Først innsendt

10. juli 2026

Først innsendt som oppfylte QC-kriteriene

10. juli 2026

Først lagt ut (Faktiske)

15. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2025-10 (Istanbul Medipol University Scientific Research Projects Commission)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

only unidentifiable data will be shared.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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