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Cervical DysfunctionNCT02249858

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

An observational study of Cervical Dysfunction, run by New York Institute of Technology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cervical Dysfunction
What is being tested?
Cranial Vault Hold and Cervical HVLA
Type of treatment
Surgery or procedure
How many people
51 participants
Where
1 siteUnited States
Study dates
Nov 2013to May 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participants will be 1st and 2nd year NYIT-COM medical students. 52 students will be recruited.

Who may be able to join

  • 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

Who cannot join

  • contraindications to HVLA
  • diagnosis of fibromyalgia syndrome
  • neck or back or cervical spine pain
  • herniated nucleus pulposus
  • bone diseases (such as osteoporosis)
  • rheumatoid arthritis
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • New York Institute of Technology College of Osteopathic Medicine

    Old Westbury, New York, 11568

Other trials in United States

About this study

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.

Read more

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.

Read the detailed description

The osteopathic philosophy applies to manipulative treatment as well as viewing an individual as a whole entity. The neuromusculoskeletal system is important to sustaining a healthy life. The musculoskeletal system is intimately connected with all other systems of the body through both the voluntary and involuntary nervous systems. Osteopathic physicians are trained to evaluate the neuromusculoskeletal system and work to achieve normal body mechanics through the use of manual manipulative medicine.

Osteopathic physicians use palpatory examination to identify somatic dysfunctions. The accepted definition in the Glossary of Osteopathic Terminology is: "Somatic dysfunction is an impaired or altered function of related components of the somatic (body framework) system: Skeletal, arthrodial, and myo-fascial structures, and related vascular, lymphatic and neural elements". Physicians assess for texture changes, asymmetry, restriction of motion, and tenderness. After performing OMT, such as HVLA, a dysfunction is reassessed by palpatory assessment once again. While there are studies which show the effectiveness of OMT, a challenge remains to objectively assess a somatic dysfunction.

According to the Glossary of Osteopathic Terminology, HVLA technique is defined as "An osteopathic technique employing 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. In the past, osteopathic manipulation was synonymous with the thrust technique. This may have been because this technique can be taught by accurately describing the nature of the restriction and providing techniques for treating the dysfunction.

Proper diagnosis of a joint dysfunction is important for spinal manipulation. However, little assessment has been made of the clinician's ability to reliably identify a joint with biomechanical dysfunctions. Few studies attempts to address the challenge of evidence-based clinical practice. In a study by Degenhardt et al., investigators looked into the inter-observer reliability of the osteopathic palpatory tests. While the study showed that consensus training did show some improvement in the inter-observer reliability, many previously published studies failed to show a level of reproducibility that supports the use of palpation in evidence-based clinical practice. Najm et al. systematic review paper reasoned that one of the challenges behind evaluating the validity of palpatory assessment is due to the lack of a reference standard measuring means. The reference standard can be used to measure the findings made by palpation.

In a study conducted by Shaw et al. they were able to use an ultrasound machine to assess the content validity of palpatory examination as well as to provide objective evidence of the effect of HVLA on somatic dysfunction in the lumbar spine. We aim to adapt their protocol for the cervical spine. The study conducted by Shaw et al. did not have a control group. In our study, we aim to have a control group which will not be getting treatment in the cervical spine. The control group will be subjected to the cranial vault hold which is generally used to assess the primary respiratory mechanism in the cranium and 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 segment. Based on Shaw et al. study, we hypothesize that an ultrasound is a reliable instrument to objectively evaluate somatic dysfunction of the cervical spine. Furthermore, we hypothesize that after performing cervical HVLA, the left and right articular pillars of the key somatic dysfunction vertebrae should be symmetrical compared to baseline.

Previous studies show certain effects observed after an HVLA manipulation. In a systematic review paper by Hegedus et al., it was found that after a single spinal joint mobilization, there were temporary neurophysiological effects for approximately 5 minutes or less. Studies that have revealed the neurophysiological effects of spinal manual therapy have caused a paradigm shift away from a strict biomechanical model. This is important because the neurophysiological effects include pain-related measures, changes in skin conductance, changes in skin temperature and improvements in range of motion with neural tensioning. In a study performed by Martinez-Segura et al., it was found that a single cervical HVLA manipulation was more effective in reducing neck pain at rest and increasing active cervical range of motion than a control mobilization procedure in subjects suffering from mechanical neck pain.

This research design holds significant importance. It can potentially prove intra- and inter-examiner reliability of palpatory assessment. In addition, ultrasonography can be used as a reference standard for evaluating somatic dysfunctions. Furthermore, this study will enable investigators to quantify the palpatory assessment and the extent to which HVLA has an effect on a key somatic dysfunction in the cervical spine. Using an ultrasound machine for the study holds many advantages. It is relatively safe and noninvasive. It enables investigators to visualize the cervical anatomy without any radiation and minimal harm to the participants. Using a cervical goniometric device, investigators will observe how the osteopathic techniques that are utilized in this study will affect active range of motion. The total time of participation is 60 minutes, and the change in range of motion from baseline to 1 hour following the intervention will be assessed.

Being tested
Cranial Vault Hold, Cervical HVLA
Keywords
cervical spine, OMT, HVLA, ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cranial Vault HoldProcedure or surgery

  • Cervical HVLAProcedure or surgery

Study groups in NCT02249858
Study groupRoleWhat they receive
Control Group: Cranial Vault Protocol GroupCranial vault protocol group will receive cranial vault hold.
Receives: Procedure: Cranial Vault Hold
Experimental Group: HVLA Protocol GroupHVLA protocol group will receive cervical HVLA to the key somatic dysfunction C2-C7 segment.
Receives: Procedure: Cervical HVLA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cervical Range of Motion

    Measured rotation of the cervical spine

    Measured: Change in baseline in cervical range of motion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2014 (estimated)
  2. Study startNov 2013
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02249858
Sponsor's protocol ID
BHS-988
Status last verified
Oct 2017
First submitted
11 Feb 2014
Last updated
9 Oct 2017
Results posted
No
Data monitoring committee
No

Publications

  • Burns DK, Wells MR. Gross range of motion in the cervical spine: the effects of osteopathic muscle energy technique in asymptomatic subjects. J Am Osteopath Assoc. 2006 Mar;106(3):137-42.

    PubMed 16585381
  • Hegedus EJ, Goode A, Butler RJ, Slaven E. The neurophysiological effects of a single session of spinal joint mobilization: does the effect last? J Man Manip Ther. 2011 Aug;19(3):143-51. doi: 10.1179/2042618611Y.0000000003.

    PubMed 22851877
  • Martinez-Segura R, Fernandez-de-las-Penas C, Ruiz-Saez M, Lopez-Jimenez C, Rodriguez-Blanco C. Immediate effects on neck pain and active range of motion after a single cervical high-velocity low-amplitude manipulation in subjects presenting with mechanical neck pain: a randomized controlled trial. J Manipulative Physiol Ther. 2006 Sep;29(7):511-7. doi: 10.1016/j.jmpt.2006.06.022.

    PubMed 16949939
  • Najm WI, Seffinger MA, Mishra SI, Dickerson VM, Adams A, Reinsch S, Murphy LS, Goodman AF. Content validity of manual spinal palpatory exams - A systematic review. BMC Complement Altern Med. 2003 May 7;3:1. doi: 10.1186/1472-6882-3-1. Epub 2003 May 7.

    PubMed 12734016
  • Potter L, McCarthy C, Oldham J. Intraexaminer reliability of identifying a dysfunctional segment in the thoracic and lumbar spine. J Manipulative Physiol Ther. 2006 Mar-Apr;29(3):203-7. doi: 10.1016/j.jmpt.2006.01.005.

    PubMed 16584944
  • Degenhardt BF, Snider KT, Snider EJ, Johnson JC. Interobserver reliability of osteopathic palpatory diagnostic tests of the lumbar spine: improvements from consensus training. J Am Osteopath Assoc. 2005 Oct;105(10):465-73.

    PubMed 16314679
  • Shaw KA, Dougherty JJ, Treffer KD, Glaros AG. Establishing the content validity of palpatory examination for the assessment of the lumbar spine using ultrasonography: a pilot study. J Am Osteopath Assoc. 2012 Dec;112(12):775-82. doi: 10.7556/jaoa.2012.112.12.775.

    PubMed 23212428
  • Wood TG, Colloca CJ, Matthews R. A pilot randomized clinical trial on the relative effect of instrumental (MFMA) versus manual (HVLA) manipulation in the treatment of cervical spine dysfunction. J Manipulative Physiol Ther. 2001 May;24(4):260-71. doi: 10.1067/mmt.2001.114365.

    PubMed 11353937
  • Gupta A, Kaur K, Sharma S, Goyal S, Arora S, Murthy RS. Clinical aspects of acute post-operative pain management & its assessment. J Adv Pharm Technol Res. 2010 Apr;1(2):97-108.

    PubMed 22247838

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Dysfunction, run by New York Institute of Technology at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cervical Range of Motion (time frame: Change in baseline in cervical range of motion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02249858, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2017.

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