NCT03176654

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 1, 2019

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

1 month

First QC Date

June 2, 2017

Results QC Date

January 30, 2018

Last Update Submit

July 30, 2019

Conditions

Neck Pain, Posterior

Outcome Measures

Primary Outcomes (2)

  • Plasma Concentration of Oxytocin

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

    Blood will be drawn 10 minutes prior to HVLAT procedure.

  • Plasma Concentration of Oxytocin

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

    Blood will be drawn immediately after HVLAT procedure.

Secondary Outcomes (6)

  • Plasma Concentration of Neurotensin

    Within 10 minutes after consent signature completion

  • Plasma Concentration of Neurotensin

    Blood will be drawn immediately after HVLAT procedure.

  • Plasma Concentration of Orexin A

    Within 10 minutes after consent signature completion

  • Plasma Concentration of Orexin A

    Blood will be drawn immediately after HVLAT procedure.

  • Plasma Concentration of Cortisol

    Within 10 minutes after consent signature completion

  • +1 more secondary outcomes

Study Arms (2)

HVLAT manipulation

EXPERIMENTAL

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.

Procedure: HVLAT manipulation

Sham HVLAT manipulation

SHAM COMPARATOR

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.

Procedure: Sham HVLAT manipulation

Interventions

HVLAT manipulationPROCEDURE

HVLAT will be performed 10 minutes after the first blood draw.

HVLAT manipulation
Sham HVLAT manipulationPROCEDURE

Sham HVLAT will be performed 10 minutes after the first blood draw.

Sham HVLAT manipulation

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

Related Publications (2)

  • 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.

    PMID: 20510644BACKGROUND

  • 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.

    PMID: 20184717BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

One limitation of this study may be the lack of a control group with no touch contact. There may be an increase in oxytocin in both groups as a consequence of the touch and pressure applied to the subject's cervical spine.

Results Point of Contact

Title
Everett Lohman, PhD. Professor
Organization
Loma Linda University Health
elohman@llu.edu

Study Officials

  • Everett Lohman, D.Sc.

    Loma Linda University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Experimental Group (HVLAT manipulation) Control Group (sham HVLAT manipulation)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
D.Sc., P.T., OCS Professor Allied Health.

Study Record Dates

First Submitted

June 2, 2017

First Posted

June 5, 2017

Study Start

August 15, 2016

Primary Completion

September 20, 2016

Study Completion

September 20, 2016

Last Updated

August 1, 2019

Results First Posted

August 1, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)