- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03176654
The Effect of Manipulation of the Cervical Spine on Pain Biomarkers (HVLAT)
July 30, 2019 updated by: Everett Lohman, Loma Linda University
The Effect of High-Velocity Low-Amplitude Thrust Manipulation of the Cervical Spine on Pain Biomarkers in Females With Non-Specific Mechanical Neck Pain
This study evaluates the effect of high-velocity low-amplitude thrust (HVLAT) manipulation to the cervical spine on neuropeptide expression as determined by the plasma concentration of oxytocin, neurotensin, orexin A and cortisol; and Examine the effect of HVLAT manipulation on pain perception in symptomatic females with non-specific mechanical cervical spine pain
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A high-velocity low-amplitude thrust (HVLAT) manipulation or commonly known as a spinal manipulation, is an intervention frequently used by physical therapists and other healthcare practitioners as an alternative treatment to help relieve spinal pain The mechanism by which HVLAT manipulation modulates pain remains undefined, although this does not contradict the clinical effects from HVLAT manipulation.
Furthermore, there is evidence that suggests analgesia after HVLAT manipulation.
There is a variety of observed and proposed phenomena that can explain the mechanisms for the psychological, mechanical, or neurophysiological responses from a HVLAT manipulation associated with alterations in pain processing or sympathetic and motor systems' excitation.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Loma Linda, California, United States, 92350
- Loma Linda University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 20 - 45 years of age
- A score of 10 or more out of 50 on the Neck Disability Index (NDI) questionnaire
- Symptoms of pain present for 30 days or less and no pain symptoms below your shoulder
Exclusion Criteria:
- Serious condition (such as cancer, spondylolisthesis, rheumatoid arthritis, or ankylosing spondylitis)
- Cervical spinal stenosis signs (such as incoordination in hands, arms and legs, inability of walking at a brisk pace, or bowel and bladder incontinence)
- Nerve root compression (such as changes in sensation, muscle weakness, or decreased reflexes)
- Works the night shift
- Steroid medication within 3 months
- Pregnancy or postpartum
- Pending legal action regarding their neck pain
- History of whiplash associated disorder and/or cervical spine surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HVLAT manipulation
An HVLAT manipulation is applied to the site of pain or restriction with the patient in supine.
This technique uses both primary levers (pre-manipulation rotation - away (30 ° - 45 °) from the side of pain or limitation) and secondary levers (Side bending - towards coupled with lateral shift - away, and posterior-anterior (PA) shift (extension).
This is a bimanual technique.
For the applicator hand, the anterolateral portion of the first or second phalanx of the second ray was positioned on the superior joint partner of the target vertebrae using a cradle hold.
The other hand is placed on the posterolateral aspect of the occiput (above the ear).
While maintaining these positions the clinician performed the thrust with the arc of rotation dependent on the level of the target vertebrae.
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HVLAT will be performed 10 minutes after the first blood draw.
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Sham Comparator: Sham HVLAT manipulation
Subjects in the control group were instructed to lay on a table in the same position as the HVLAT manipulation group.
The clinician went through the same basic steps as the HVLAT manipulation, localizing the appropriate vertebral landmarks but without carrying out the final HVLA thrust procedure.
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Sham HVLAT will be performed 10 minutes after the first blood draw.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Concentration of Oxytocin
Time Frame: Blood will be drawn 10 minutes prior to HVLAT procedure.
|
Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
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Blood will be drawn 10 minutes prior to HVLAT procedure.
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Plasma Concentration of Oxytocin
Time Frame: Blood will be drawn immediately after HVLAT procedure.
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Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
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Blood will be drawn immediately after HVLAT procedure.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Concentration of Neurotensin
Time Frame: Within 10 minutes after consent signature completion
|
Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
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Within 10 minutes after consent signature completion
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Plasma Concentration of Neurotensin
Time Frame: Blood will be drawn immediately after HVLAT procedure.
|
Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
|
Blood will be drawn immediately after HVLAT procedure.
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Plasma Concentration of Orexin A
Time Frame: Within 10 minutes after consent signature completion
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Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
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Within 10 minutes after consent signature completion
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Plasma Concentration of Orexin A
Time Frame: Blood will be drawn immediately after HVLAT procedure.
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Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
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Blood will be drawn immediately after HVLAT procedure.
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Plasma Concentration of Cortisol
Time Frame: Within 10 minutes after consent signature completion
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Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
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Within 10 minutes after consent signature completion
|
Plasma Concentration of Cortisol
Time Frame: Blood will be drawn immediately after HVLAT procedure.
|
Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
|
Blood will be drawn immediately after HVLAT procedure.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Everett Lohman, D.Sc., Loma Linda University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL; COG. Manipulation or mobilisation for neck pain: a Cochrane Review. Man Ther. 2010 Aug;15(4):315-33. doi: 10.1016/j.math.2010.04.002. Epub 2010 May 26.
- Bronfort G, Haas M, Evans R, Leininger B, Triano J. Effectiveness of manual therapies: the UK evidence report. Chiropr Osteopat. 2010 Feb 25;18:3. doi: 10.1186/1746-1340-18-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2016
Primary Completion (Actual)
September 20, 2016
Study Completion (Actual)
September 20, 2016
Study Registration Dates
First Submitted
June 2, 2017
First Submitted That Met QC Criteria
June 2, 2017
First Posted (Actual)
June 5, 2017
Study Record Updates
Last Update Posted (Actual)
August 1, 2019
Last Update Submitted That Met QC Criteria
July 30, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5160076
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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