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The Effect of Manipulation of the Cervical Spine on Pain Biomarkers (HVLAT)

Primary Purpose

Neck Pain, Posterior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HVLAT manipulation
Sham HVLAT manipulation
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neck Pain, Posterior

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Loma Linda University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

HVLAT manipulation

Sham HVLAT manipulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Plasma Concentration of Oxytocin
Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Plasma Concentration of Oxytocin
Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).

Secondary Outcome Measures

Plasma Concentration of Neurotensin
Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Plasma Concentration of Neurotensin
Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Plasma Concentration of Orexin A
Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Plasma Concentration of Orexin A
Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Plasma Concentration of Cortisol
Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Plasma Concentration of Cortisol
Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).

Full Information

First Posted
June 2, 2017
Last Updated
July 30, 2019
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT03176654
Brief Title
The Effect of Manipulation of the Cervical Spine on Pain Biomarkers
Acronym
HVLAT
Official Title
The Effect of High-Velocity Low-Amplitude Thrust Manipulation of the Cervical Spine on Pain Biomarkers in Females With Non-Specific Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 15, 2016 (Actual)
Primary Completion Date
September 20, 2016 (Actual)
Study Completion Date
September 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Posterior

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental Group (HVLAT manipulation) Control Group (sham HVLAT manipulation)
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HVLAT manipulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham HVLAT manipulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
HVLAT manipulation
Intervention Description
HVLAT will be performed 10 minutes after the first blood draw.
Intervention Type
Procedure
Intervention Name(s)
Sham HVLAT manipulation
Intervention Description
Sham HVLAT will be performed 10 minutes after the first blood draw.
Primary Outcome Measure Information:
Title
Plasma Concentration of Oxytocin
Description
Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Time Frame
Blood will be drawn 10 minutes prior to HVLAT procedure.
Title
Plasma Concentration of Oxytocin
Description
Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Time Frame
Blood will be drawn immediately after HVLAT procedure.
Secondary Outcome Measure Information:
Title
Plasma Concentration of Neurotensin
Description
Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Time Frame
Within 10 minutes after consent signature completion
Title
Plasma Concentration of Neurotensin
Description
Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Time Frame
Blood will be drawn immediately after HVLAT procedure.
Title
Plasma Concentration of Orexin A
Description
Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Time Frame
Within 10 minutes after consent signature completion
Title
Plasma Concentration of Orexin A
Description
Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Time Frame
Blood will be drawn immediately after HVLAT procedure.
Title
Plasma Concentration of Cortisol
Description
Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Time Frame
Within 10 minutes after consent signature completion
Title
Plasma Concentration of Cortisol
Description
Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Time Frame
Blood will be drawn immediately after HVLAT procedure.

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Everett Lohman, D.Sc.
Organizational Affiliation
Loma Linda University
Official's Role
Study Chair
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20510644
Citation
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.
Results Reference
background
PubMed Identifier
20184717
Citation
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.
Results Reference
background

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The Effect of Manipulation of the Cervical Spine on Pain Biomarkers

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