INYBI Tool in Chronic Neck Pain

NCT ID: NCT03902119

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-24
• Study Completion Date: 2019-09-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

INYBI tool

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Manual suboccipital inhibition

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Alberto Marcos Heredia-Rizo

Assistant Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto Heredia-Rizo, PhD

Role: STUDY_DIRECTOR

Physiotherapy Department, University of Sevilla, Spain

Locations

University of Sevilla

Seville, , Spain

Countries

Spain

Other Identifiers

INYBI tool

Identifier Type: -

Identifier Source: org_study_id