The Effect of Manipulation of the Cervical Spine on Pain Biomarkers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neck Pain, Posterior

Intervention / Treatment
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* Procedure: HVLAT manipulation
* Procedure: Sham HVLAT manipulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental Group (HVLAT manipulation) Control Group (sham HVLAT manipulation)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HVLAT manipulation<br>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<br>* HVLAT will be performed 10 minutes after the first blood draw.<br>|
| Sham Comparator: Sham HVLAT manipulation<br>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<br>* Sham HVLAT will be performed 10 minutes after the first blood draw.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of Neurotensin | Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Within 10 minutes after consent signature completion | 
| Plasma Concentration of Neurotensin | Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Blood will be drawn immediately after HVLAT procedure. | 
| Plasma Concentration of Orexin A | Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Within 10 minutes after consent signature completion | 
| Plasma Concentration of Orexin A | Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Blood will be drawn immediately after HVLAT procedure. | 
| Plasma Concentration of Cortisol | Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Within 10 minutes after consent signature completion | 
| Plasma Concentration of Cortisol | Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Blood will be drawn immediately after HVLAT procedure. |