Clinical trial NCT03902119: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: neck pain
randomized control trial
manual therapy
physical therapy
suboccipital inhibition
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Pressure pain threshold (PPT) in the evaluated muscles. The PPT levels will be evaluated in Kilograms / cm2
timeFrame: From baseline to immediately after treatment.
measure: Active cervical range of movement (ROM). The range of movement will be assessed in degrees
timeFrame: From baseline to immediately after treatment.
measure: Pain free vertical mouth opening. This outcome will be evaluated in centimeters.
timeFrame: From baseline to immediately after treatment.
measure: Atlas rotation ROM, assessed in degrees
timeFrame: From baseline to immediately after treatment.
measure: Self-reported pain intensity
timeFrame: From baseline to immediately after treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: University of Sevilla
Study officials:
affiliation: Physiotherapy Department, University of Sevilla, Spain
name: Alberto Heredia-Rizo, PhD
role: STUDY_DIRECTOR
References: