Neck Pain Clinical Trial
Official title:
Effects of Cervical Manipulation and Mobilization on Salivary Cortisol Concentrations
Verified date | April 2017 |
Source | University of Alcala |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Currently, there are many studies about the effects of manual therapy on pain, but there are
not enough studies to know what are the mechanisms that cause these effects.
Although there is a research measuring neuromodulators substances after a cervical and
dorsal manipulation, it has been done in healthy subjects and there is no information about
mobilization. This work aims to select a sample with chronic neck pain, incorporating the
cervical mobilization as a therapeutic approach to compare the effects of both techniques
because not all patients accept the manipulation as a treatment technique (mobilization is
much better tolerated) and to verify that the liberation of cortisol is not just caused by
the stress on the joint manipulation and the psychological stress and expectation may be
important.
The hypothesis of this paper is that cervical manipulation and mobilization in subjects with
chronic neck pain there will increase salivary cortisol levels.
It is also expected a little increase in the expectation of being manipulated group because
of the psychological stress.
It is expected an improvement in the neck disability, pain and range of motion in the
intervention groups immediately after and in the three groups the following week after the
exercise.
The main objective of the study is to measure and analyze changes in salivary cortisol
concentrations after the intervention in the three groups. Secondary objectives is to
analyze the changes in range of motion and disability caused by neck pain neck pain level
Status | Completed |
Enrollment | 54 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Manifest mechanical pain in the neck to the T1 vertebra as lower limit - Present the medical diagnosis of mechanical neck pain - Do not be getting any kind of hormonal therapy (including oral contraceptives) - Be over 18 years old Exclusion Criteria: - Subjects that are associated with the adrenal gland pathology - Pathologies excess or defect of cortisol - Pathology severe psychological disorders related to anxiety, mood or stress - Participants pregnant due to changes in hormonal determinations - Contraindication to manipulation or mobilization |
Country | Name | City | State |
---|---|---|---|
Spain | Alcalá Universuty | Alcalá de Henares | Madrid |
Lead Sponsor | Collaborator |
---|---|
University of Alcala | Valera-Calero JA; Plaza-Manzano G; Gallego-Izquierdo T |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | salivary cortisol | For measuring salivary cortisol a Cortisol kit RE52611 ELISA® will be provided by the IBL laboratory. The saliva samples will be stored at -20 ° C until analysis, being coded by the researcher and measured by a blinded assessor. For this, it will be added 50 uL sample of saliva in the tubes of the kit with a pipette. Subsequently 100 uL of enzyme conjugate will be added to each tube, covering the plate with adhesive and shaking carefully. It will be incubated 2 hours at room temperature (18-25 ° C) in a centrifuge at 400-600 rpm. After removing the adhesive and remove excess of solution wil be added 100 uL of TMB solution. It wil be centrifuged for 30 min under the same conditions. At the end, they wil be added 100 uL of TMB solution inhibitory. The results wil be measured with a photometer at 450 nm within 15 minutes of adding the last reagent. |
Change from baseline cortisol concentration at after the intervention(immediately after) | |
Secondary | Neck Disability | This test is a questionnaire of 10 questions to fill in the patient and disability measured by neck pain. It has been shown to have high reliability "test-retest" and be valid when compared with other measures of pain and disability | Change from baseline disability at one week after intervention | |
Secondary | Neck pain | Using a visual analogue scale (VAS) of 10 cm consisting of an opaque unnumbered rule by the front and numbered from 0 to 10 in the back side with an expression of no pain at 0 cm and maximum pain at 10 cm | Change from baseline neck pain at one week after intervention | |
Secondary | Tenderness | With a algometer we will assessed the tenderness upon facet joints C2-C3 and C5-C6 | Change from baseline pain threshold pressure at after the intervention (immediately after) and one week after | |
Secondary | Cervical joint Range | Flexion, inclination, extension and rotational movement ranges will be measured with a cervical goniometer | Change from baseline mobility at immediately after at one week after intervention |
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