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.
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
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.
- Conditions
- Cervical Dysfunction
- 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 group | Role | What they receive |
|---|---|---|
| Control Group: Cranial Vault Protocol Group | Cranial vault protocol group will receive cranial vault hold. Receives: Procedure: Cranial Vault Hold | |
| Experimental Group: HVLA Protocol Group | HVLA 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.
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.
- First posted26 Sep 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cervical DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theodore Flaum, DO, Principal investigator, New York Institute of Technology
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 16585381Hegedus 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 22851877Martinez-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 16949939Najm 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 12734016Potter 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 16584944Degenhardt 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 16314679Shaw 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 23212428Wood 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 11353937Gupta 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palpatory and Ultrasound Assessment of Cervical Dysfunctions and the Effect of Cervical High Velocity Low Amplitude (HVLA) Technique
- ClinicalTrials.gov ID
- NCT02249858
- Acronym / sponsor ID
- BHS-988
- Conditions
- Cervical Dysfunction
- Keywords
- cervical spine, OMT, HVLA, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Cranial Vault Protocol Group | – | Procedure: Cranial Vault HoldCranial vault protocol group will receive cranial vault hold. |
| Experimental Group: HVLA Protocol Group | – | Procedure: Cervical HVLAHVLA protocol group will receive cervical HVLA to the key somatic dysfunction C2-C7 segment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be 1st and 2nd year NYIT-COM medical students. 52 students will be recruited.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- contraindications to HVLA
- diagnosis of fibromyalgia syndrome
- neck or back or cervical spine pain
- herniated nucleus pulposus
- bone diseases (such as osteoporosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranial Vault Hold | Procedure or surgery | Control Group: Cranial Vault Protocol Group |
| Cervical HVLA | Procedure or surgery | Experimental Group: HVLA Protocol Group |
Primary outcome
Cervical Range of Motion
Time frame: Change in baseline in cervical range of motion
Measured rotation of the cervical spine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Background: PubMed 16585381Burns 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.
- Background: PubMed 22851877Hegedus 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.
- Background: PubMed 16949939Martinez-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.
- Background: PubMed 12734016Najm 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.
- Background: PubMed 16584944Potter 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.
- Background: PubMed 16314679Degenhardt 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.
- Background: PubMed 23212428Shaw 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.
- Background: PubMed 11353937Wood 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.
- Background: PubMed 22247838Gupta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore Flaum, DO principal investigator
New York Institute of Technology
1 site in 1 country: see every site and its status.
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.