Effects of Cervical Manipulation and Mobilization on Salivary Cortisol Concentrations

NCT02628470 | Completed DMC

• 1 other identifier: CEI/HU/2015/10
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neck Pain

Keywords

Cervical pain, cervicalgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Neck Disability

  Change from baseline disability at one week after intervention

• Neck pain

  Change from baseline neck pain at one week after intervention

• Tenderness

  Change from baseline pain threshold pressure at after the intervention (immediately after) and one week after

• Cervical joint Range

  Change from baseline mobility at immediately after at one week after intervention

Study Arms (3)

group cervical manipulation

EXPERIMENTAL

The patient is supine without a pillow and physiotherapist standing in the ipsilateral corner of the hand of the thrust.

Procedure: cervical manipulation

Placebo group

PLACEBO COMPARATOR

Participants will receive a protocol of domiciliary cervical control exercises.

Procedure: cervical control exercises

Group cervical mobilization

ACTIVE COMPARATOR

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

Interventions

cervical manipulation PROCEDURE

cervical high-velocity low-amplitude thrust manipulation

group cervical manipulation

cervical control exercises PROCEDURE

Exercises of flexion, extension and rotation of the cervical spine

Placebo group

Oscillatory mobilization technique PROCEDURE

Joint mobilization technique type III according Maitland

Group cervical mobilization

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alcala: lead
• Valera-Calero JA; Plaza-Manzano G; Gallego-Izquierdo T: collaborator

Study Sites (1)

Alcalá Universuty

Alcalá de Henares, Madrid, 28806, Spain

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Tomás Gallego-Izquierdo, Dr

  Alcalá University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Pecos-Martin, D

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 11, 2015
• Study Start: December 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

ES (1)