Clinical trial NCT02802189: The Effect of Integrated Neuromuscular Inhibition Technique in Combination With Therapeutic Exercise on Patients With Chronic Mechanical Neck Pain
Official title: The Effect of Integrated Neuromuscular Inhibition Technique in Combination With Therapeutic Exercise on Patients With Chronic Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Chronic Mechanical Neck Pain
exercise
Integrated Neuromuscular Inhibition Technique
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the combine effect of the integrated neuromuscular inhibition technique (soft tissue mobilization techniques protocol), in combination with the therapeutic exercise in patients with chronic mechanical neck pain in the sub-acute stage of symptoms, and to determine whether this combination substantially helps the faster and more efficient installation of adaptations of exercising.

Detailed description: Neck pain is one of the most common and costly musculoskeletal disorders in Western societies, which witnesses high prevalence of repeatability and chronicity. In chronic mechanical neck pain, there are changes in the neck area, due to muscular imbalance between deep neck flexors (longus capitis and longus colli) and superficial flexors of the neck (sternocleidomastoid and anterior scalene). Therapeutic exercise plays a key role in the restoration of this muscle imbalance, comprising a combination of resistant and endurance training. The integrated neuromuscular inhibition technique (INIT) is a manual deactivation trigger points technique and includes the application of ischemic pressure and stretch, the muscle energy technique and the Strain-counterstrain technique.

The aim of the research is to investigate whether the application of INIT combined with exercise can reduce the time required to establish the benefits of training and improve faster and to a greater extent the clinical figure and the quality of life of patients with chronic neck pain.

Method. Single blind clinical trial lasting for 10 weeks, 40 participants (men/women) with chronic mechanical neck pain. Participants will be divided into two groups, following the same exercise program. The first group (experimental) will follow the exercise programme in combination with the integrated neuromuscular inhibition technique (INIT), while the second (active comparator) will apply the same program excluding the INIT technique. The subjective perception of pain by the visual analogue scale, the functionality related to neck pain with neck disability index, ppt of the neck muscles with pressure algometry, active range of motion with a bubble inclinometer, maximum isometric strength of neck muscles with a hand dynamometer, muscular fatigue of the flexors of the neck with special tests and the quality of life with the sf-36 questionnaire will be evaluated before, during and after the intervention, while follow-ups will take place one, three and six months later.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic neck pain with a duration of symptoms for at least three months
* Existence of at least one active or latent trigger point in any of the muscles: levator scapulae, upper trapezoid, and splenius capitis
* Patients whose neck pain has emerged as a result of a specific pathology, confirmed by radio-diagnostic tests (X-ray or MRI)
* Patients with a medical referral for physical therapy with the etiology of neck pain

Exclusion Criteria:

* Patients who are in the acute stage of symptoms
* Patients who have participated in any kind of treatment during the last three months (physiotherapy, massage, local injections of anesthetic blocks, etc.)
* Patients who have participated in an exercise program concerning their neck during the last six months
* Background of neck trauma and / or surgery in the neck region
* Inflammatory muscle diseases and joint infections, malignancy

Primary outcomes:
measure: Changes in subjective perception of neck pain with the visual analogue scale (VAS)
timeFrame: pre-treatment, Week: 2, 4, 6,10,14, 22, 34
measure: Changes in Pressure Pain threshold with pressure algometry
timeFrame: pre-treatment, Week: 2, 4, 6, 10, 14, 22, 34
measure: Changes in functional capacity with Neck disability index questionnaire
timeFrame: pre-treatment, Week 6, 10, 14, 22, 34
measure: Changes in maximum isometric strength of neck muscles with Manual Muscular Testing
timeFrame: pre-treatment, Week: 2, 4, 6,10,14, 22, 34
measure: Changes in Cervical Range of Motion with a bubble inclinometer
timeFrame: pre-treatment, Week: 2, 4, 6,10,14, 22, 34
measure: Changes in deep flexors muscle endurance with craniocervical flexion test
timeFrame: pre-treatment, Week: 2, 4, 6,10,14, 22, 34
measure: Changes in isometric endurance capacity of sternocleidomastoid and anterior scalene, with a handheld stopwatch
timeFrame: pre-treatment, Week: 2, 4, 6,10,14, 22, 34
Secondary outcomes:
measure: Changes in quality of life with the sort form of SF-36 Health Survey
timeFrame: pre-treatment, Week: 10, 14, 22, 34
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki
state: New facilities, Thermi, THESSALONIKI
Study officials:
References: