INYBI Tool in Chronic Neck Pain

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

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 Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Device: INYBI tool; Other: Manual suboccipital inhibition

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41009
    • University of Sevilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Seville
• Investigators: Study Director: Alberto Heredia-Rizo, PhD, Physiotherapy Department, University of Sevilla, Spain

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2019
• Primary Completion (Actual): September 27, 2019
• Study Completion (Actual): September 27, 2019

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 27, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: neck pain; manual therapy; physical therapy; randomized control trial; suboccipital inhibition
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: INYBI tool

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No