The Effect of Manipulation of the Cervical Spine on Pain Biomarkers

Neck Pain, Posterior Clinical Trial

— HVLAT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176654
• Other study ID #: 5160076
• Status: Completed
• Phase: N/A
• Start date: August 15, 2016
• Est. completion date: September 20, 2016

Study information

• Verified date: July 2019
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 20, 2016
• Est. primary completion date: September 20, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain
• Neck Pain, Posterior

Intervention

Procedure:
• HVLAT manipulation
HVLAT will be performed 10 minutes after the first blood draw.
• Sham HVLAT manipulation
Sham HVLAT will be performed 10 minutes after the first blood draw.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Brønfort 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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
Secondary	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.