INYBI Tool in Chronic Neck Pain

NCT03902119 | Completed DMC

• 1 other identifier: INYBI tool
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

neck pain; randomized control trial; manual therapy; physical therapy; suboccipital inhibition

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (2)

INIBY tool

EXPERIMENTAL

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

Manual suboccipital inhibition

ACTIVE COMPARATOR

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

Interventions

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.

INIBY tool

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.

Manual suboccipital inhibition

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

University of Sevilla

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Alberto Heredia-Rizo, PhD

  Physiotherapy Department, University of Sevilla, Spain

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffesor

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 3, 2019
• Study Start: April 24, 2019
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)