Clinical trial NCT03176654: The Effect of Manipulation of the Cervical Spine on Pain Biomarkers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain, Posterior
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 28
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental Group (HVLAT manipulation) Control Group (sham HVLAT manipulation)
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma Concentration of Oxytocin
timeFrame: Blood will be drawn 10 minutes prior to HVLAT procedure.
measure: Plasma Concentration of Oxytocin
timeFrame: Blood will be drawn immediately after HVLAT procedure.
Secondary outcomes:
measure: Plasma Concentration of Neurotensin
timeFrame: Within 10 minutes after consent signature completion
measure: Plasma Concentration of Neurotensin
timeFrame: Blood will be drawn immediately after HVLAT procedure.
measure: Plasma Concentration of Orexin A
timeFrame: Within 10 minutes after consent signature completion
measure: Plasma Concentration of Orexin A
timeFrame: Blood will be drawn immediately after HVLAT procedure.
measure: Plasma Concentration of Cortisol
timeFrame: Within 10 minutes after consent signature completion
measure: Plasma Concentration of Cortisol
timeFrame: Blood will be drawn immediately after HVLAT procedure.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Everett Lohman, D.Sc.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.