Upper Cervical Spine Rotational HypomobilityNCT02855216
Effects of Two Sub-occipital Techniques on Limited Mobility According to the Flexion-rotation Test
A study testing Manual technique of sub-occipital inhibition and Self-treatment by way of Occipivot® in people with Upper Cervical Spine Rotational Hypomobility, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
The cervical spine should work as a functional unit. If hypomobility should exist in any of the segments it would limit the mobility of the spine as a whole. Although it is frequent that certain cervical segments present hypomobility, they are not always related to symptomatology. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Cervical Spine Rotational Hypomobility
- What is being tested?
- Manual technique of sub-occipital inhibition and Self-treatment by way of Occipivot®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2016to Oct 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Flexion rotation test with less than 32º or asymmetry of 10º between right and left, whenever one of the sides does not exceed physiological C1-C2 ROM (45º)
- Sing the informed consent form.
Who cannot join
- Inability to tolerate FRT
- Contraindication to manual therapy.
- Cervical treatment during the study.
- Poor language and communication skills making difficult to undertand the informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unidad de Investgación en Fisioterapia. Universidad de Zaragoza
Zaragoza, 50009
About this study
Official title: Comparative Study of the Effects of Two Sub-occipital Techniques on Healthy Subjects With Limited Mobility According to the Flexion-rotation Test
The cervical spine should work as a functional unit. If hypomobility should exist in any of the segments it would limit the mobility of the spine as a whole. Although it is frequent that certain cervical segments present hypomobility, they are not always related to symptomatology. The effects of inhibition sub-occipital techniques on cervical mobility have not been evaluated.
The objetive of this trials is to assess and compare the effects on cervical mobility, of the manual technique of sub-occipital inhibition by applying pressure and self-treatment by way of Occipivot® cushion, in subjects with no cervical symptomatology but with limited mobility assessed by the flexion-rotation test.
- Being tested
- Manual technique of sub-occipital inhibition, Self-treatment by way of Occipivot®
- Keywords
- Physiotherapy, Range of motion, Inhibition sub-occipital techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual technique of sub-occipital inhibitionOther
Self-treatment by way of Occipivot®Other
| Study group | Role | What they receive |
|---|---|---|
| Manual technique of sub-occipital inhibition | Experimental | The technique applied to Manual Group was performed with the patient supine position. Physiotherapist in a sitting position at the head of the subject with forearms resting on the table . Suboccipital region was located , and flexing the metacarpophalangeal joints 90º a pressure was made ventrally , relaxing the rest of the head in the heel of the hand.
The technique was performed for 5 minutes Receives: Other: Manual technique of sub-occipital inhibition |
| Self-treatment by way of Occipivot® | Experimental | The technique applied to the Instrumental Group was performed with the patient supine in the same position as the Manual Group . It was previously instructed the subject how to proceed with the cushion Occipivot® , indicating the installation location and method of affixing , correcting him if the application was inadequate. The subject placed the cushion Occipivot® under the suboccipital region and told him he had to stay in that position for 5 minutes. A physiotherapist warned the patient at the end of the application time so that the subject had to be aware not to control it. Receives: Other: Self-treatment by way of Occipivot® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline in Range of movement in Upper Cervical Spine
Flexion-rotation test measured by CROM device
Measured: 15 minutes after intervention
Secondary outcomes (2)
Change in baseline in Range of motion of cervical spine
Measured: 15 minutes after intervention
Change in baseline in Upper cervical spine range of motion
Measured: 15 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Cervical Spine Rotational HypomobilityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andoni Carrasco, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855216
- Sponsor's protocol ID
- PI16/0147
- Status last verified
- May 2018
- First submitted
- 1 Aug 2016
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Effects of Two Sub-occipital Techniques on Healthy Subjects With Limited Mobility According to the Flexion-rotation Test
- ClinicalTrials.gov ID
- NCT02855216
- Acronym / sponsor ID
- PI16/0147
- Keywords
- Physiotherapy, Range of motion, Inhibition sub-occipital techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 4 Aug 2016 (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.
The cervical spine should work as a functional unit. If hypomobility should exist in any of the segments it would limit the mobility of the spine as a whole. Although it is frequent that certain cervical segments present hypomobility, they are not always related to symptomatology. The effects of inhibition sub-occipital techniques on cervical mobility have not been evaluated.
The objetive of this trials is to assess and compare the effects on cervical mobility, of the manual technique of sub-occipital inhibition by applying pressure and self-treatment by way of Occipivot® cushion, in subjects with no cervical symptomatology but with limited mobility assessed by the flexion-rotation test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual technique of sub-occipital inhibition | Experimental | Other: Manual technique of sub-occipital inhibitionThe technique applied to Manual Group was performed with the patient supine position. Physiotherapist in a sitting position at the head of the subject with forearms resting on the table . Suboccipital region was located , and flexing the metacarpophalangeal joints 90º a pressure was made ventrally , relaxing the rest of the head in the heel of the hand. The technique was performed for 5 minutes |
| Self-treatment by way of Occipivot® | Experimental | Other: Self-treatment by way of Occipivot®The technique applied to the Instrumental Group was performed with the patient supine in the same position as the Manual Group . It was previously instructed the subject how to proceed with the cushion Occipivot® , indicating the installation location and method of affixing , correcting him if the application was inadequate. The subject placed the cushion Occipivot® under the suboccipital region and told him he had to stay in that position for 5 minutes. A physiotherapist warned the patient at the end of the application time so that the subject had to be aware not to control it. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Flexion rotation test with less than 32º or asymmetry of 10º between right and left, whenever one of the sides does not exceed physiological C1-C2 ROM (45º)
- Sing the informed consent form.
Key exclusion criteria (4 listed)
- Inability to tolerate FRT
- Contraindication to manual therapy.
- Cervical treatment during the study.
- Poor language and communication skills making difficult to undertand the informed consent.
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 |
|---|---|---|
| Manual technique of sub-occipital inhibition | Other | Manual technique of sub-occipital inhibition |
| Self-treatment by way of Occipivot® | Other | Self-treatment by way of Occipivot® |
Primary outcome
Change in baseline in Range of movement in Upper Cervical Spine
Time frame: 15 minutes after intervention
Flexion-rotation test measured by CROM device
2 secondary outcomes
Change in baseline in Range of motion of cervical spine
Time frame: 15 minutes after intervention
Change in baseline in Upper cervical spine range of motion
Time frame: 15 minutes 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 7 May 2018.
- Individual participant dataSharing planned: No
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 Manual technique of sub-occipital inhibition and Self-treatment by way of Occipivot® in people with Upper Cervical Spine Rotational Hypomobility, run by Universidad de Zaragoza 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 2 inclusion and 4 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 7 May 2018. 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. 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?
Change in baseline in Range of movement in Upper Cervical Spine (time frame: 15 minutes after intervention). 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 7 May 2018.