- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02855216
Effects of Two Sub-occipital Techniques on Limited Mobility According to the Flexion-rotation Test
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Zaragoza, Spain, 50009
- Unidad de Investgación en Fisioterapia. Universidad de Zaragoza
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Manual technique of sub-occipital inhibition
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 |
|
Experimental: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in baseline in Range of movement in Upper Cervical Spine
Time Frame: 15 minutes after intervention
|
Flexion-rotation test measured by CROM device
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15 minutes after intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in baseline in Range of motion of cervical spine
Time Frame: 15 minutes after intervention
|
15 minutes after intervention
|
Change in baseline in Upper cervical spine range of motion
Time Frame: 15 minutes after intervention
|
15 minutes after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PI16/0147
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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