Neck Pain Clinical Trial
Official title:
Effectiveness of a New Tool (INYBI) in Individuals With Chronic Non-specific Neck Pain.
Verified date | October 2019 |
Source | University of Seville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | September 27, 2019 |
Est. primary completion date | September 27, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of non-specific mechanical neck pain. - Pain of more than 3 months of duration. - Pain between the occiput and the third dorsal vertebra. - Willingness to participate in the treatment and in the follow-up measurements - Neck pain reproduced by neck movements or palpation Exclusion Criteria: - Cognitive impairment or inability to communicate. - Having received manual therapy in the last two months before recruitment. - Having received anti-inflammatory treatment, antidepressants or muscle relaxants in the last 72 hours. - Any contraindication to treatment or evaluation procedures. - Diagnosis of systemic diseases - Diagnosis of fibromyalgia - Pregnancy - Signs of spinal nerve root compression - Previous whiplash - Any diagnosed possible cause for their neck pain (infection, cancer, spinal stenosis) |
Country | Name | City | State |
---|---|---|---|
Spain | University of Sevilla | Sevilla |
Lead Sponsor | Collaborator |
---|---|
University of Seville |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pressure pain threshold (PPT) in the evaluated muscles. The PPT levels will be evaluated in Kilograms / cm2 | PPT levels, defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer. | From baseline to immediately after treatment. | |
Primary | Active cervical range of movement (ROM). The range of movement will be assessed in degrees | Flexion, extension, left and right side flexion, and left and right rotation will be assessed using a digital inclinometer. | From baseline to immediately after treatment. | |
Primary | Pain free vertical mouth opening. This outcome will be evaluated in centimeters. | Maximum pain free vertical mouth opening will be assessed using a digital caliper that will place between the incisors 11, 21, 31 y 41. | From baseline to immediately after treatment. | |
Primary | Atlas rotation ROM, assessed in degrees | 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 | From baseline to immediately after treatment. | |
Primary | Self-reported pain intensity | 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 | From baseline to immediately after treatment. |
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