The Effect of Manipulation of the Cervical Spine on Pain Biomarkers

Not Applicable

Completed

• Conditions: Neck Pain, Posterior

• Registration Number: NCT03176654
• Lead Sponsor: Loma Linda University

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.

Study Timeline

• Study Start: 2016-08-15
• Primary Completion: 2016-09-20
• Study Completion: 2016-09-20
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-05
• Results First Submitted: 2018-01-30
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-30
• Last Update Submitted: 2019-07-30
• Results First Posted: 2019-08-01
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Plasma Concentration of Oxytocin	Blood will be drawn immediately after HVLAT procedure.	Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).

Secondary Outcome Measures

Name	Time	Method
Plasma Concentration of Neurotensin	Blood will be drawn immediately after HVLAT procedure.	Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Plasma Concentration of Cortisol	Blood will be drawn immediately after HVLAT procedure.	Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
Plasma Concentration of Orexin A	Blood will be drawn immediately after HVLAT procedure.	Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States