INYBI Tool in Chronic Neck Pain

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902119
• Other study ID #: INYBI tool
• Status: Completed
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: September 27, 2019

Study information

• Verified date: October 2019
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Neck Pain

Intervention

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.

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.

Locations

Country	Name	City	State
Spain	University of Sevilla	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

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.