Skip to main content
OpenTrials
Completed

NCT Number: NCT03902119

INYBI Tool in Chronic 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sevilla

Seville, 41009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

INYBI tool

Device

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.

Manual suboccipital inhibition

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2019
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.