Cervical Stabilization in Individuals With Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT03154970|
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Craniocervical flexion training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Cervical Stabilization in Individuals With Obstructive Sleep Apnea: a Randomized Clinical Trial|
|Actual Study Start Date :||May 22, 2017|
|Actual Primary Completion Date :||July 30, 2017|
|Actual Study Completion Date :||August 30, 2017|
Experimental: Obstructive sleep apnea group (G OSA)
The cervical stabilization will be performed with craniocervical flexion training aiming to strength the deep cervical flexors. For this purpose a pressure biofeedback device (stabilizer) that allows progressive levels of pressure during exercise(22-30 mmHg) will be used, which will be increased according to the capacity of the individuals (avoiding compensations or pain). The participant will be instructed to perform the craniocervical flexion in the supine position, the duration of the contraction will be 10 seconds followed by 10 seconds of rest (3 sets of 10 repetitions). The sessions will be held 2 times in weeks, for 6 weeks.
Device: Craniocervical flexion training
The cervical stabilization will be performed with craniocervical flexion training with two weekly sessions for 6 weeks
No Intervention: Control group (GC)
The GC will be reassessed after six weeks and the same G OSA treatment will be offered after this period.
- Change of sleep quality [ Time Frame: Baseline and 7 weeks ]Sleep quality will be assessed twice through the Pittsburgh sleep quality index (PSQI), composed of nine self-administered questions, with scores scattered on a scale of zero to three. The sum of the responses provided by the overall score, which ranges from zero to 21, where the higher the score, the worse the quality of sleep.
- Change of craniocervical dysfunction index [ Time Frame: Baseline and 7 weeks ]The craniocervical dysfunction index evaluates the cervical function and is composed of five items: amplitude of cervical movements, presence of pain to cervical movement, presence of noises and blockages in the cervical joints, pain on the palpation of the cervical muscles and craniocervical posture. For each evaluated item three scores are possible (0, 1 or 5) and the volunteers can be classified into four categories according to the severity of the dysfunction: no dysfunction (0 points), mild dysfunction (1 to 4 points), moderate dysfunction (5 to 9 points) and severe (10 to 25 points)
- Change of pressure pain threshold [ Time Frame: Baseline and 7 weeks ]
The pressure pain threshold will be evaluated by means of an analog algometer (Wagner Instruments). This appliance has a 1 cm rubber ferrule attached at its end, which will be positioned perpendicular to the muscular surface.
For this, the participants will be seated in a chair, with the trunk upright, back fully supported, feet resting on the ground and hands resting on the lower limbs. The pressure pain threshold will be bilaterally assessed in the masseter (upper, middle and lower) and temporal (anterior, middle and posterior) muscles, submandibular region, posterior mandibular region, sternocleidomastoid, upper trapezius and suboccipital muscles. All points will be gradually pressed up to the intensity that the participant reports any pain intensity, this value being visualized on the equipment and recorded as pain threshold at pressure.
- Change of presence and and severity of temporomandibular dysfunction (TMD) [ Time Frame: Baseline and 7 weeks ]
The instrument that will be used to evaluate presence of TMD is Diagnostic criteria in research for temporomandibular disorders (RDC / TMD), which is divided in 2 axis: in Axis I allows the measurement of TMD signs and symptoms (physical evaluation) and in Axis II it evaluates the psychological and psychosocial factors (questionnaire).
To measure TMD severity the Temporomandibular Index (TMI) is used, this result is obtained from RDC/TMD data from Axis I. Result is a qualification among light (0 to 0,3), moderate (0,3 a 0,6) or severe (0,6 to1) TMD according to TMI calculated.
- Change of cervical posture [ Time Frame: Baseline and 7 weeks ]The posture of the head and cervical spine will be evaluated by means of digital photography, with posterior analysis in the Postural Evaluation Software (SAPo v 0.68®). The anatomical points of the tragus, spinous process of the seventh cervical vertebra and orbicular commissure will be demarcated with Styrofoam balls in the participant's body.
- Change of muscle strength [ Time Frame: Baseline and 7 weeks ]
The evaluation of muscle strength of cervical flexors and extensors will be performed using a Microfet 2 manual dynamometer (Hoggan Health industries, West Jordan, USA). For the assessment of cervical flexors, the participant will be positioned in the supine position, knees extended, head and neck in neutral position. The manual dynamometer will be positioned in the midline of the frontal bone and will be held by the evaluator, while the participant performs the maximum voluntary isometric contraction of the cervical flexors.
In order to evaluate the strength of the cervical extensors the participant will be positioned in the prone position, with the upper limbs next to the trunk. The manual dynamometer will be positioned in the line of the occipital protuberance.
Data from three repetitions will be obtained for flexion and cervical extension, each repetition lasts 5 seconds and the rest period between the repetitions is 60 seconds.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154970
|Universidade Federal de Santa Maria|
|Santa Maria, Rio Grande Do Sul, Brazil, 97105-900|