Movement DisordersNCT04001868
Sub Occipital Inhibition Technique on Postural Balance
A study testing Suboccipital inhibition in people with Movement Disorders, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
In the present study the investigators want to verify if the inhibition of the suboccipital muscles improves the postural balance in subjects with cervical pain objectified by stabilometry. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Movement Disorders
- What is being tested?
- Suboccipital inhibition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jul 2019to 18 Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who suffer neck pain for at least 3 months
- Come to receive physiotherapy treatment at Clinica Osteomed (NRS: 8415-CV), Elche, Alicante, Spain.
- Age between 18 and 65 years old.
- Sign the informed consent.
Who cannot join
- Suffering or having suffered pathologies of the postural control system (postural sensors, central nervous system or locomotor system)
- Presenting deformities or orthopedic injuries in the lower limbs or rachis
- Presenting pain at the moment of study
- Present contraindications to the intervention under study
- Have received physiotherapy treatment in the last six months
- Have undergone surgical treatment of any kind.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effect of Sub Occipital Inhibition Technique on Postural Balance: Stabilometric Study.
In the present study the investigators want to verify if the inhibition of the suboccipital muscles improves the postural balance in subjects with cervical pain objectified by stabilometry.
- Conditions
- Movement Disorders
- Being tested
- Suboccipital inhibition, Placebo technique
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suboccipital inhibitionProcedure or surgery
With the patient in the supine position and the therapist sitting at the head of the bed with the elbows resting on its surface. The therapist palpates the cervical spinous processes and slides the fingers upwards until contacting the posterior projection of the posterior arch of the atlas. Then, flexing the metacarpophalangeal at 90 degrees slowly raises the skull. The therapist's hands should remain together and the base of the skull should rest on his palms pressing with the index, middle and ring fingers of each hand in a sustained manner, but without causing pain. This pressure must be maintained during 4 minutes.
Placebo techniqueProcedure or surgery
A superficial contact in the same area as the intervention, to rule out the exteroceptive effect associated with the therapist's contact.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Application of the sub occipital inhibition technique. Receives: Procedure: Suboccipital inhibition |
| Placebo Group | Placebo comparator | Hand contact in the sub occipital region without executing any technique. Receives: Procedure: Placebo technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface of the ellipse open eyes
Determines the surface of the ellipse formed from the oscillations in the X and Y coordinates with open eyes. The measurement is made using a stabilometric platform with 4 pressure sensors per square centimeter. The software of the stabilometric platform collects 40 measurements per second through its pressure sensors, calculating the position of the projection of the center of gravity on the ground 40 times every second. The described variable evaluates the surface of the ellipse that contains the successive points of the displacement of the projection of the center of gravity in the ground during the standarized time for the stabilometric recording (51.2 seconds). It is a unique value, measured in a single moment. If the ellipse formed is larger, it implies a greater amplitude of the displacement of the center of gravity, and therefore a lower equilibrium capacity. Interval: 0-1000 (mm2).
Measured: Postintervention immediate
Surface of the ellipse closed eyes
Determines the surface of the ellipse formed from the oscillations in the X and Y coordinates with closed eyes. The measurement is made using a stabilometric platform with 4 pressure sensors per square centimeter. The software of the stabilometric platform collects 40 measurements per second through its pressure sensors, calculating the position of the projection of the center of gravity on the ground 40 times every second. The described variable evaluates the surface of the ellipse that contains the successive points of the displacement of the projection of the center of gravity in the ground during the standarized time for the stabilometric recording (51.2 seconds). It is a unique value, measured in a single moment. If the ellipse formed is larger, it implies a greater amplitude of the displacement of the center of gravity, and therefore a lower equilibrium capacity. Interval: 0-1000 (mm2).
Measured: Postintervention immediate
Secondary outcomes (4)
Mean of the oscillation on the X axis and on the Y axis.
It assesses the lateral and anteroposterior oscillation of the projection on the floor of the center of gravity during the 51 seconds of the stabilometric record. Interval: 0-50 (mm). Greater oscillation implies less postural balance.
Measured: Preintervention and Postintervention immediate.
Speed of the oscillation on the X axis and on the Y axis
Determines the speed with which the projection of the center of gravity moves in lateral and anteroposterior direction during the 51 seconds of the stabilometric record. Interval: 0-10 (mm/s). Greater speed implies less postural balance.
Measured: Preintervention and Postintervention immediate.
Average speed of the oscillation
Determines the average speed with which the projection of the center of gravity moves in lateral and anteroposterior direction during the 51 seconds of the stabilometric record. Interval: 0-10 (mm/s). Greater speed implies less postural balance.
Measured: Preintervention and Postintervention immediate.
Length of oscillation
Determine the length of movement described by the projection on the ground of the center of gravity during the stabilometric measurement. Interval: 0-1000 (mm). Greater length implies less postural balance.
Measured: Preintervention and Postintervention immediate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start3 Jul 2019
- Primary completion3 Jul 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisordersStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERGIO MONTERO NAVARRO, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001868
- Sponsor's protocol ID
- CEU UCH 212
- Status last verified
- Dec 2019
- First submitted
- 19 Jun 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Sub Occipital Inhibition Technique on Postural Balance: Stabilometric Study.
- ClinicalTrials.gov ID
- NCT04001868
- Acronym / sponsor ID
- CEU UCH 212
- Conditions
- Movement Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 28 Jun 2019 (actual)
- 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.
In the present study the investigators want to verify if the inhibition of the suboccipital muscles improves the postural balance in subjects with cervical pain objectified by stabilometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Suboccipital inhibitionApplication of the sub occipital inhibition technique. |
| Placebo Group | Placebo comparator | Procedure: Placebo techniqueHand contact in the sub occipital region without executing any technique. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals who suffer neck pain for at least 3 months
- Come to receive physiotherapy treatment at Clinica Osteomed (NRS: 8415-CV), Elche, Alicante, Spain.
- Age between 18 and 65 years old.
- Sign the informed consent.
Key exclusion criteria (6 listed)
- Suffering or having suffered pathologies of the postural control system (postural sensors, central nervous system or locomotor system)
- Presenting deformities or orthopedic injuries in the lower limbs or rachis
- Presenting pain at the moment of study
- Present contraindications to the intervention under study
- Have received physiotherapy treatment in the last six months
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 |
|---|---|---|
| Suboccipital inhibitionWith the patient in the supine position and the therapist sitting at the head of the bed with the elbows resting on its surface. The therapist palpates the cervical spinous processes and slides the fingers upwards until contacting the posterior projection of the posterior arch of the atlas. Then, flexing the metacarpophalangeal at 90 degrees slowly raises the skull. The therapist's hands should remain together and the base of the skull should rest on his palms pressing with the index, middle and ring fingers of each hand in a sustained manner, but without causing pain. This pressure must be maintained during 4 minutes. | Procedure or surgery | Experimental Group |
| Placebo techniqueA superficial contact in the same area as the intervention, to rule out the exteroceptive effect associated with the therapist's contact. | Procedure or surgery | Placebo Group |
Primary outcome
Surface of the ellipse open eyes
Time frame: Postintervention immediate
Determines the surface of the ellipse formed from the oscillations in the X and Y coordinates with open eyes. The measurement is made using a stabilometric platform with 4 pressure sensors per square centimeter. The software of the stabilometric platform collects 40 measurements per second through its pressure sensors, calculating the position of the projection of the center of gravity on the ground 40 times every second. The described variable evaluates the surface of the ellipse that contains the successive points of the displacement of the projection of the center of gravity in the ground during the standarized time for the stabilometric recording (51.2 seconds). It is a unique value, measured in a single moment. If the ellipse formed is larger, it implies a greater amplitude of the displacement of the center of gravity, and therefore a lower equilibrium capacity. Interval: 0-1000 (mm2).
Surface of the ellipse closed eyes
Time frame: Postintervention immediate
Determines the surface of the ellipse formed from the oscillations in the X and Y coordinates with closed eyes. The measurement is made using a stabilometric platform with 4 pressure sensors per square centimeter. The software of the stabilometric platform collects 40 measurements per second through its pressure sensors, calculating the position of the projection of the center of gravity on the ground 40 times every second. The described variable evaluates the surface of the ellipse that contains the successive points of the displacement of the projection of the center of gravity in the ground during the standarized time for the stabilometric recording (51.2 seconds). It is a unique value, measured in a single moment. If the ellipse formed is larger, it implies a greater amplitude of the displacement of the center of gravity, and therefore a lower equilibrium capacity. Interval: 0-1000 (mm2).
4 secondary outcomes
Mean of the oscillation on the X axis and on the Y axis.
Time frame: Preintervention and Postintervention immediate.
Speed of the oscillation on the X axis and on the Y axis
Time frame: Preintervention and Postintervention immediate.
Average speed of the oscillation
Time frame: Preintervention and Postintervention immediate.
Length of oscillation
Time frame: Preintervention and Postintervention immediate.
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 19 Dec 2019.
- The University CEU Cardenal Herrera is the first private university in the Valencia Community. It belongs to the Foundation San Pablo - CEU and is the leading educational organization in Spain with three Universities all over SpainLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suboccipital inhibition in people with Movement Disorders, run by Cardenal Herrera University 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 6 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 19 Dec 2019. 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?
Surface of the ellipse open eyes (time frame: Postintervention immediate). The study lists 2 primary outcomes in all. 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 19 Dec 2019.