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INYBI Tool in Chronic Neck Pain

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ClinicalTrials.gov Identifier: NCT03902119
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Alberto Marcos Heredia-Rizo, University of Seville

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.


Condition or disease Intervention/treatment Phase
Neck Pain Device: INYBI tool Other: Manual suboccipital inhibition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a New Tool (INYBI) in Individuals With Chronic Non-specific Neck Pain.
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902119


Contacts
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Contact: Alberto Heredia-Rizo, PhD +34954486507 amheredia@us.es
Contact: Angel Oliva-Pascual-Vaca, PhD +34954486507 angeloliva@us.es

Locations
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Spain
University of Sevilla Not yet recruiting
Sevilla, Spain, 41009
Contact: Angel Oliva-Pascual-Vaca, PhD       angeloliva@us.es   
Principal Investigator: Cristina Perez, PhD         
University of Sevilla Recruiting
Sevilla, Spain, 41009
Contact: Alberto M Heredia-Rizo, PhD    +34 954486507    amheredia@us.es   
Sponsors and Collaborators
University of Seville
Investigators
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Study Director: Alberto Heredia-Rizo, PhD Physiotherapy Department, University of Sevilla, Spain

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Responsible Party: Alberto Marcos Heredia-Rizo, Assistant Proffesor, University of Seville
ClinicalTrials.gov Identifier: NCT03902119     History of Changes
Other Study ID Numbers: INYBI tool
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alberto Marcos Heredia-Rizo, University of Seville:
neck pain
randomized control trial
manual therapy
physical therapy
suboccipital inhibition

Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms