Neck PainNCT02628470
Effects of Cervical Manipulation and Mobilization on Salivary Cortisol Concentrations
A study testing cervical manipulation and Oscillatory mobilization technique in people with Neck Pain, run by University of Alcala at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- cervical manipulation and Oscillatory mobilization technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
Read the detailed description
STUDY DESIGN:
Experimental study using a randomized controlled trial with blinded evaluator with three parallel groups, two experimental and one placebo.
INTERVENTION
- Experimental group cervical manipulation: The patient is supine without a pillow and physiotherapist standing in the ipsilateral corner of the hand of the thrust. If the segment to manipulate is the upper cervical spine, the radial aspect of the distal phalanx of the index finger of the pulse is placed on the posterolateral aspect of the transverse process of the atlas (In medium or low segments of cervical spine on the vertebra on which we want to make the thrust). The thumb rests on the zygomatic arch and the other fingers rest on the back of the skull, leaving the forearm perpendicular to the neck. In middle or lower cervical spine, the thumb rests on the angle of the jaw and the other fingers on the back of the neck. The contralateral hand rests against the contralateral side of the patient's skull with the fingers facing caudally, so we left ear between the index and middle fingers. To take the patient to the end of range of motion will be added ipsilateral inclination and contralateral rotation without exceeding the 30-40 °. There will be a contralateral displacement of the head and a posteroanterior glide to take the patient to energizing. The impulse is made in pure contralateral rotation.
- Experimental Group of cervical posterior-anterior mobilization in the most painful segment: Maitland described by the patient is prone with his forehead in the palms. The thumb rests on the articular pillar (on the transverse blade) and the other fingers around the neck to stabilize the soft tissue. The limit pressure will be that cause pain to the patient. The oscillatory motion is produced by the arms and the body while the hands remain stable with a pressure distributed uniformly around the patient's neck. It is important that the neck and hands move as a unit. high-amplitude technique may be performed by raising the patient's neck with the pads of the fingers This technique was performed for 3 minutes remaining below the pain threshold of the patient.
- Placebo group:
The subjects of this group will expect a cervical manipulation to check the psychological component has an effect on cortisol segregation. It will proceed with the same protocol as in the group of cervical manipulation, but without joint stress or thrust.
Participants will receive a protocol of domiciliary cervical control exercises adapted to each subject for deep cervical muscles after taking the second salivary sample.
Seasonal timing will be considered (evaluating the subjects in the same month), circadian rhythms (evaluating subjects mid-morning to avoid peak morning cortisol) and periods of the menstrual cycle as they are factors that can determine the results. In the case of the menstrual cycle they are cited the seventh day of the cycle.
- Conditions
- Neck Pain
- Being tested
- cervical manipulation, cervical control exercises, Oscillatory mobilization technique
- Keywords
- Cervical pain, cervicalgia
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical manipulationProcedure or surgery
cervical high-velocity low-amplitude thrust manipulation
cervical control exercisesProcedure or surgery
Exercises of flexion, extension and rotation of the cervical spine
Oscillatory mobilization techniqueProcedure or surgery
Joint mobilization technique type III according Maitland
| Study group | Role | What they receive |
|---|---|---|
| group cervical manipulation | Experimental | The patient is supine without a pillow and physiotherapist standing in the ipsilateral corner of the hand of the thrust. Receives: Procedure: cervical manipulation |
| Placebo group | Placebo comparator | Participants will receive a protocol of domiciliary cervical control exercises. Receives: 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 Receives: Procedure: Oscillatory mobilization technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline cortisol concentration at after the intervention(immediately after)
Secondary outcomes (4)
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
Measured: Change from baseline disability at one week after intervention
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
Measured: Change from baseline neck pain at one week after intervention
Tenderness
With a algometer we will assessed the tenderness upon facet joints C2-C3 and C5-C6
Measured: Change from baseline pain threshold pressure at after the intervention (immediately after) and one week after
Cervical joint Range
Flexion, inclination, extension and rotational movement ranges will be measured with a cervical goniometer
Measured: Change from baseline mobility at immediately after at one week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startDec 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Collaborators
- Valera-Calero JA; Plaza-Manzano G; Gallego-Izquierdo T
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Tomás Gallego-Izquierdo, Dr, Study director, Alcalá University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628470
- Sponsor's protocol ID
- CEI/HU/2015/10
- Status last verified
- Apr 2017
- First submitted
- 30 Nov 2015
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervical Manipulation and Mobilization on Salivary Cortisol Concentrations
- ClinicalTrials.gov ID
- NCT02628470
- Acronym / sponsor ID
- CEI/HU/2015/10
- Conditions
- Neck Pain
- Keywords
- Cervical pain, cervicalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Collaborators
- Valera-Calero JA; Plaza-Manzano G; Gallego-Izquierdo T
- Study start
- Dec 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
STUDY DESIGN:
Experimental study using a randomized controlled trial with blinded evaluator with three parallel groups, two experimental and one placebo.
INTERVENTION
- Experimental group cervical manipulation: The patient is supine without a pillow and physiotherapist standing in the ipsilateral corner of the hand of the thrust. If the segment to manipulate is the upper cervical spine, the radial aspect of the distal phalanx of the index finger of the pulse is placed on the posterolateral aspect of the transverse process of the atlas (In medium or low segments of cervical spine on the vertebra on which we want to make the thrust). The thumb rests on the zygomatic arch and the other fingers rest on the back of the skull, leaving the forearm perpendicular to the neck. In middle or lower cervical spine, the thumb rests on the angle of the jaw and the other fingers on the back of the neck. The contralateral hand rests against the contralateral side of the patient's skull with the fingers facing caudally, so we left ear between the index and middle fingers. To take the patient to the end of range of motion will be added ipsilateral inclination and contralateral rotation without exceeding the 30-40 °. There will be a contralateral displacement of the head and a posteroanterior glide to take the patient to energizing. The impulse is made in pure contralateral rotation.
- Experimental Group of cervical posterior-anterior mobilization in the most painful segment: Maitland described by the patient is prone with his forehead in the palms. The thumb rests on the articular pillar (on the transverse blade) and the other fingers around the neck to stabilize the soft tissue. The limit pressure will be that cause pain to the patient. The oscillatory motion is produced by the arms and the body while the hands remain stable with a pressure distributed uniformly around the patient's neck. It is important that the neck and hands move as a unit. high-amplitude technique may be performed by raising the patient's neck with the pads of the fingers This technique was performed for 3 minutes remaining below the pain threshold of the patient.
- Placebo group:
The subjects of this group will expect a cervical manipulation to check the psychological component has an effect on cortisol segregation. It will proceed with the same protocol as in the group of cervical manipulation, but without joint stress or thrust.
Participants will receive a protocol of domiciliary cervical control exercises adapted to each subject for deep cervical muscles after taking the second salivary sample.
Seasonal timing will be considered (evaluating the subjects in the same month), circadian rhythms (evaluating subjects mid-morning to avoid peak morning cortisol) and periods of the menstrual cycle as they are factors that can determine the results. In the case of the menstrual cycle they are cited the seventh day of the cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group cervical manipulation | Experimental | Procedure: cervical manipulationThe patient is supine without a pillow and physiotherapist standing in the ipsilateral corner of the hand of the thrust. |
| Placebo group | Placebo comparator | Procedure: cervical control exercisesParticipants will receive a protocol of domiciliary cervical control exercises. |
| Group cervical mobilization | Active comparator | Procedure: Oscillatory mobilization techniqueOscillatory mobilization technique. With the patient in prone, the investigator applies an oscillatory motion in the most painful cervical segment for three minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical manipulationcervical high-velocity low-amplitude thrust manipulation | Procedure or surgery | group cervical manipulation |
| cervical control exercisesExercises of flexion, extension and rotation of the cervical spine | Procedure or surgery | Placebo group |
| Oscillatory mobilization techniqueJoint mobilization technique type III according Maitland | Procedure or surgery | Group cervical mobilization |
Primary outcome
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.
4 secondary outcomes
Neck Disability
Time frame: Change from baseline disability at one week after intervention
Neck pain
Time frame: Change from baseline neck pain at one week after intervention
Tenderness
Time frame: Change from baseline pain threshold pressure at after the intervention (immediately after) and one week after
Cervical joint Range
Time frame: Change from baseline mobility at immediately after at one week after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomás Gallego-Izquierdo, Dr study director
Alcalá University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical manipulation and Oscillatory mobilization technique in people with Neck Pain, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivary cortisol (time frame: Change from baseline cortisol concentration at after the intervention(immediately after)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.