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Completed

NCT Number: NCT03176654

The Effect of Manipulation of the Cervical Spine on Pain Biomarkers

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

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92350, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HVLAT manipulation

Procedure

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

Sham HVLAT manipulation

Procedure

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

Primary outcomes

  1. 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).

  2. Plasma Concentration of Oxytocin

    Time frame: Blood will be drawn immediately after HVLAT procedure.

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

Secondary outcomes

  1. 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).

  2. 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).

  3. Plasma Concentration of Orexin A

    Time frame: Within 10 minutes after consent signature completion

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

  4. Plasma Concentration of Orexin A

    Time frame: Blood will be drawn immediately after HVLAT procedure.

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

  5. Plasma Concentration of Cortisol

    Time frame: Within 10 minutes after consent signature completion

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

  6. 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).

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study 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

Acronym: HVLAT

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 5, 2017
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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