Effects of Cervical Manipulation and Mobilization on Salivary Cortisol Concentrations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02628470|
Recruitment Status : Completed
First Posted : December 11, 2015
Last Update Posted : April 26, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Neck Pain||Procedure: cervical manipulation Procedure: cervical control exercises Procedure: Oscillatory mobilization technique||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of Cervical Manipulation and Mobilization on Salivary Cortisol Concentrations|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Experimental: group cervical manipulation
The patient is supine without a pillow and physiotherapist standing in the ipsilateral corner of the hand of the thrust.
Procedure: cervical manipulation
cervical high-velocity low-amplitude thrust manipulation
Placebo Comparator: Placebo group
Participants will receive a protocol of domiciliary cervical control exercises.
Procedure: cervical control exercises
Exercises of flexion, extension and rotation of the cervical spine
Active Comparator: Group cervical mobilization
Oscillatory mobilization technique. With the patient in prone, the investigator applies an oscillatory motion in the most painful cervical segment for three minutes
Procedure: Oscillatory mobilization technique
Joint mobilization technique type III according Maitland
- salivary cortisol [ Time Frame: Change from baseline cortisol concentration at after the intervention(immediately after) ]
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.
- Neck Disability [ Time Frame: Change from baseline disability at one week after intervention ]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
- Neck pain [ Time Frame: Change from baseline neck pain at one week after intervention ]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
- Tenderness [ Time Frame: Change from baseline pain threshold pressure at after the intervention (immediately after) and one week after ]With a algometer we will assessed the tenderness upon facet joints C2-C3 and C5-C6
- Cervical joint Range [ Time Frame: Change from baseline mobility at immediately after at one week after intervention ]Flexion, inclination, extension and rotational movement ranges will be measured with a cervical goniometer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628470
|Alcalá de Henares, Madrid, Spain, 28806|
|Study Director:||Tomás Gallego-Izquierdo, Dr||Alcalá University|