The Effect of Manipulation of the Cervical Spine on Pain Biomarkers

The Effect of High-Velocity Low-Amplitude Thrust Manipulation of the Cervical Spine on Pain Biomarkers in Females With Non-Specific Mechanical Neck Pain

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03176654

Acronym

HVLAT

Enrollment

Registered

2017-06-05

Start date

2016-08-15

Completion date

2016-09-20

Last updated

2019-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain, Posterior

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.

Interventions

PROCEDUREHVLAT manipulation

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

PROCEDURESham HVLAT manipulation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Intervention model description

Experimental Group (HVLAT manipulation) Control Group (sham HVLAT manipulation)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Plasma Concentration of Oxytocin	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).

Secondary

Measure	Time frame	Description
Plasma Concentration of Neurotensin	Within 10 minutes after consent signature completion	Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Plasma Concentration of Orexin A	Within 10 minutes after consent signature completion	Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Plasma Concentration of Cortisol	Within 10 minutes after consent signature completion	Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. HVLAT manipulation: HVLAT will be performed 10 minutes after the first blood draw.	13
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. Sham HVLAT manipulation: Sham HVLAT will be performed 10 minutes after the first blood draw.	15
Total	28

Baseline characteristics

Characteristic	Sham HVLAT Manipulation	Total	HVLAT Manipulation
Age, Customized Mean age of participants	30 years	37 years	37 years
Race and Ethnicity Not Collected	—	0 Participants	—
Sex/Gender, Customized	15 Participants	28 Participants	13 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 13	0 / 15
other Total, other adverse events	0 / 13	0 / 15
serious Total, serious adverse events	0 / 13	0 / 15

Outcome results

Primary

Plasma Concentration of Oxytocin

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.