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INYBI Tool in Chronic Neck Pain

Effectiveness of a New Tool (INYBI) in Individuals With Chronic Non-specific Neck Pain.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03902119
Enrollment
58
Registered
2019-04-03
Start date
2019-04-24
Completion date
2019-09-27
Last updated
2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain

Keywords

neck pain, randomized control trial, manual therapy, physical therapy, suboccipital inhibition

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.

Interventions

DEVICEINYBI 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.

OTHERManual 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.

Sponsors

University of Seville
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Pressure pain threshold (PPT) in the evaluated muscles. The PPT levels will be evaluated in Kilograms / cm2From 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 degreesFrom 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.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 degreesFrom 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 intensityFrom 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026