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Palpatory and Ultrasound Assessment of Cervical Dysfunctions and the Effect of Cervical High Velocity Low Amplitude (HVLA) Technique

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ClinicalTrials.gov Identifier: NCT02249858
Recruitment Status : Completed
First Posted : September 26, 2014
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
New York Institute of Technology

Brief Summary:

Osteopathic medicine is a distinct school of medicine. Osteopathic physicians evaluate the neuromusculoskeletal system and work to achieve normal body mechanics. They use palpation to identify somatic dysfunctions. After performing osteopathic manipulative treatment (OMT), such as high velocity low amplitude (HVLA), a dysfunction is reassessed by palpatory assessment. While there are studies which show the effectiveness of OMT, a challenge remains to objectively assess a somatic dysfunction.

The purpose of this study is to investigate the content validity of the palpatory examination for the cervical spine using ultrasonography and the effects of a single cervical HVLA technique. Content validity is the extent to which a measure adequately and comprehensively measures what it claims to be measuring. The Investigators aim to objectively assess diagnosis and treatment of the cervical spine.

HVLA technique employs a rapid, therapeutic force of brief duration that travels a short distance within the anatomic range of motion of a joint, and that engages the restrictive barrier in one or more planes of motion to elicit release of restriction. It is also known as a thrust technique. The goal of the treatment is the restoration of physiological motion to the dysfunctional joint.

Proper diagnosis of a joint dysfunction is important for spinal manipulation. Little assessment has been made of the clinician's ability to reliably identify a joint with biomechanical dysfunctions. Few studies attempt to address the challenge of evidence-based clinical practice. These have found the benefit of consensus training.

In a study conducted by Shaw et al., ultrasound machine was used to assess the content validity of palpatory examination and objectively assess the effect of HVLA in the lumbar spine. The investigators aim to adapt the protocol for the cervical spine, but with the addition of a control cohort. Subjects will be subjected to the cranial vault hold, which assesses the primary respiratory mechanism in and the degree of participation of each bone in the general motion of the cranium. In the experimental group, participants will be receiving cervical HVLA to the key somatic dysfunction.

The Investigators hypothesize that an ultrasound is a reliable instrument to objectively evaluate somatic dysfunction of the cervical spine. Furthermore, the investigators hypothesize that after performing cervical HVLA, the left and right articular pillars of the key somatic dysfunction vertebrae should be symmetrical compared to baseline.


Condition or disease Intervention/treatment
Cervical Dysfunction Procedure: Cranial Vault Hold Procedure: Cervical HVLA

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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Palpatory and Ultrasound Assessment of Cervical Dysfunctions and the Effect of Cervical High Velocity Low Amplitude (HVLA) Technique
Actual Study Start Date : November 2013
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
Control Group: Cranial Vault Protocol Group
Cranial vault protocol group will receive cranial vault hold.
Procedure: Cranial Vault Hold
Experimental Group: HVLA Protocol Group
HVLA protocol group will receive cervical HVLA to the key somatic dysfunction C2-C7 segment.
Procedure: Cervical HVLA



Primary Outcome Measures :
  1. Cervical Range of Motion [ Time Frame: Change in baseline in cervical range of motion ]
    Measured rotation of the cervical spine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be 1st and 2nd year NYIT-COM medical students. 52 students will be recruited.
Criteria

Inclusion Criteria:

  • asymptomatic and healthy participants with not contraindications to HVLA
  • no local metastases
  • no osseous or ligamentous disruption
  • no apprehension on the part of the participant

Exclusion Criteria:

  • contraindications to HVLA
  • diagnosis of fibromyalgia syndrome
  • neck or back or cervical spine pain
  • herniated nucleus pulposus
  • bone diseases (such as osteoporosis)
  • rheumatoid arthritis
  • Down Syndrome
  • prior surgery on back
  • any cervical radiculopathy
  • if rotation of the head and neck causes dizziness, lightheadedness or pain
  • dislocation of the dens associated with rupture or laxity of the transverse ligament of the atlas.
  • advance carotid disease
  • recent history of seizures
  • stroke

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249858


Locations
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United States, New York
New York Institute of Technology College of Osteopathic Medicine
Old Westbury, New York, United States, 11568
Sponsors and Collaborators
New York Institute of Technology
Investigators
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Principal Investigator: Theodore Flaum, DO New York Institute of Technology

Publications:

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Responsible Party: New York Institute of Technology
ClinicalTrials.gov Identifier: NCT02249858    
Other Study ID Numbers: BHS-988
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Keywords provided by New York Institute of Technology:
cervical spine
OMT
HVLA
ultrasound