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INYBI Tool in Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
INYBI tool
Manual suboccipital inhibition
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, randomized control trial, manual therapy, physical therapy, suboccipital inhibition

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Sevilla

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

INIBY tool

Manual suboccipital inhibition

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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
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

Secondary Outcome Measures

Full Information

First Posted
March 27, 2019
Last Updated
October 27, 2019
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT03902119
Brief Title
INYBI Tool in Chronic Neck Pain
Official Title
Effectiveness of a New Tool (INYBI) in Individuals With Chronic Non-specific Neck Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
September 27, 2019 (Actual)
Study Completion Date
September 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
neck pain, randomized control trial, manual therapy, physical therapy, suboccipital inhibition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INIBY tool
Arm Type
Experimental
Arm Description
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
Arm Title
Manual suboccipital inhibition
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
INYBI tool
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual suboccipital inhibition
Intervention Description
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 Measure Information:
Title
Pressure pain threshold (PPT) in the evaluated muscles. The PPT levels will be evaluated in Kilograms / cm2
Description
PPT levels, defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer.
Time Frame
From baseline to immediately after treatment.
Title
Active cervical range of movement (ROM). The range of movement will be assessed in degrees
Description
Flexion, extension, left and right side flexion, and left and right rotation will be assessed using a digital inclinometer.
Time Frame
From baseline to immediately after treatment.
Title
Pain free vertical mouth opening. This outcome will be evaluated in centimeters.
Description
Maximum pain free vertical mouth opening will be assessed using a digital caliper that will place between the incisors 11, 21, 31 y 41.
Time Frame
From baseline to immediately after treatment.
Title
Atlas rotation ROM, assessed in degrees
Description
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
Time Frame
From baseline to immediately after treatment.
Title
Self-reported pain intensity
Description
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
Time Frame
From baseline to immediately after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Heredia-Rizo, PhD
Organizational Affiliation
Physiotherapy Department, University of Sevilla, Spain
Official's Role
Study Director
Facility Information:
Facility Name
University of Sevilla
City
Sevilla
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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INYBI Tool in Chronic Neck Pain

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