The Effect of Manipulation of the Cervical Spine on Pain Biomarkers

NCT ID: NCT03176654

Last Updated: 2019-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-15

Study Completion Date

2016-09-20

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.

Conditions

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Neck Pain, Posterior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental Group (HVLAT manipulation) Control Group (sham HVLAT manipulation)
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

HVLAT manipulation

Intervention Type PROCEDURE

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

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.

Group Type SHAM_COMPARATOR

Sham HVLAT manipulation

Intervention Type PROCEDURE

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

Interventions

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HVLAT manipulation

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

Intervention Type PROCEDURE

Sham HVLAT manipulation

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Everett Lohman

D.Sc., P.T., OCS Professor Allied Health.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Everett Lohman, D.Sc.

Role: STUDY_CHAIR

Loma Linda University

Locations

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Loma Linda University

Loma Linda, California, United States

Site Status

Countries

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United States

References

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Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort 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.

Reference Type BACKGROUND
PMID: 20510644 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20184717 (View on PubMed)

Other Identifiers

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5160076

Identifier Type: -

Identifier Source: org_study_id

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