INYBI Tool in Chronic Neck Pain
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|ClinicalTrials.gov Identifier: NCT03902119|
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : April 25, 2019
Objectives: To evaluate the clinical efficacy of using a manual inhibition technique for the suboccipital muscles compared with the use of the so-called INYBI tool in individuals with chronic non-specific neck pain, and the compare the results of using both approaches on pain relief, cervical range of motion neck and vertical maximum mouth opening.
Design: Quantitative, experimental, longitudinal, prospective, and double blinded study.
Subjects: Patients between 18 and 40 years, with chronic non-specific neck pain of at least 3 months of evolution.
Methods: The experimental group will undergo a 5 minutes intervention for the suboccipital muscles using the INYBI tool. The control group will receive a 5 minutes of treatment involving the suboccipital muscles manual inhibition technique.
|Condition or disease||Intervention/treatment||Phase|
|Neck Pain||Device: INYBI tool Other: Manual suboccipital inhibition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Effectiveness of a New Tool (INYBI) in Individuals With Chronic Non-specific Neck Pain.|
|Actual Study Start Date :||April 24, 2019|
|Estimated Primary Completion Date :||August 15, 2019|
|Estimated Study Completion Date :||October 15, 2019|
Experimental: INIBY tool
Patients will undergo a single treatment session consisting of applying a suboccipital muscle inhibition technique using the so-called INYBI tool. The treatment session will last approximately 5 minutes
Device: INYBI tool
Patients will lie down in supine position so that the INYBI tool will contact the suboccipital muscles at the posterior arch of the atlas. The therapist will adapt the height of the tool for each individual. All patients will use the softest head of the device. A 50Hz vibration speed will be set sup during 5 minutes.
Active Comparator: Manual suboccipital inhibition
Patients will receive a single treatment session consisting of the use of the manual suboccipital muscles inhibition technique.The treatment session will last approximately 5 minutes
Other: Manual suboccipital inhibition
Patients will lie down in supine position.The therapist will be seated at the head of the treatment table. The therapist will keep the metacarpophalangeal joints in a flexed position, while therapists fingertips of both hands will contact with the suboccipital muscles at the posterior arch of the atlas.
- Pressure pain threshold (PPT) in the evaluated muscles. The PPT levels will be evaluated in Kilograms / cm2 [ Time Frame: From baseline to immediately after treatment. ]PPT levels, defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer.
- Active cervical range of movement (ROM). The range of movement will be assessed in degrees [ Time Frame: From baseline to immediately after treatment. ]Flexion, extension, left and right side flexion, and left and right rotation will be assessed using a digital inclinometer.
- Pain free vertical mouth opening. This outcome will be evaluated in centimeters. [ Time Frame: From baseline to immediately after treatment. ]Maximum pain free vertical mouth opening will be assessed using a digital caliper that will place between the incisors 11, 21, 31 y 41.
- Atlas rotation ROM, assessed in degrees [ Time Frame: From baseline to immediately after treatment. ]The atlas bone left and right rotation ROM will be assessed using the flexion-rotation test. For this test, with the participant in supine position, the maximum mobility in head rotation while keeping maximum passive neck flexion will be assessed
- Self-reported pain intensity [ Time Frame: From baseline to immediately after treatment. ]Self-perceived pain intensity will be evaluated during all active cervical movements by a 0 to 10 Visual Analogue Scale (VAS), where 0 denotes no pain at all, and 10 denotes the maximum possible pain
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): NCT03902119
|Contact: Alberto Heredia-Rizo, PhDfirstname.lastname@example.org|
|Contact: Angel Oliva-Pascual-Vaca, PhDemail@example.com|
|University of Sevilla||Not yet recruiting|
|Sevilla, Spain, 41009|
|Contact: Angel Oliva-Pascual-Vaca, PhD firstname.lastname@example.org|
|Principal Investigator: Cristina Perez, PhD|
|University of Sevilla||Recruiting|
|Sevilla, Spain, 41009|
|Contact: Alberto M Heredia-Rizo, PhD +34 954486507 email@example.com|
|Study Director:||Alberto Heredia-Rizo, PhD||Physiotherapy Department, University of Sevilla, Spain|