INYBI Tool in Chronic Neck Pain

Not Applicable

Completed

• Conditions: Neck Pain
• Interventions: Device: INYBI tool; Other: Manual suboccipital inhibition

• Registration Number: NCT03902119
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-03
• Study Start: 2019-04-24
• Primary Completion: 2019-09-27
• Study Completion: 2019-09-27
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-27
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INIBY tool	INYBI 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
Manual suboccipital inhibition	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

Primary Outcome Measures

Name	Time	Method
Pressure pain threshold (PPT) in the evaluated muscles. The PPT levels will be evaluated in Kilograms / cm2	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.
Active cervical range of movement (ROM). The range of movement will be assessed in degrees	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.
Pain free vertical mouth opening. This outcome will be evaluated in centimeters.	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.
Atlas rotation ROM, assessed in degrees	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
Self-reported pain intensity	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

Trial Locations

Locations (1)

University of Sevilla; 🇪🇸 Sevilla, Spain