Effectiveness of a New Tool (INYBI) in Individuals With Chronic Non-specific Neck Pain.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Seville
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Pressure pain threshold (PPT) in the evaluated muscles. The PPT levels will be evaluated in Kilograms / cm2
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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
Intervention: INYBI tool (Device)
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
Intervention: Manual suboccipital inhibition (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Alberto Marcos Heredia-Rizo
Assistant Proffesor
University of Seville