Clinical trial NCT02595294: Hypoalgesic Effect of Neural Mobilization
Official title: Hypoalgesic Effect of Neural Mobilization in Cervicobrachial Pain Compared to a Controlled Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervicobrachial Neuralgia
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of these study is to compare the effectivity of the Cervical Lateral Glide physical therapy neural mobilization technique to the complete absence of treatment in a group of patients who suffer cervicobrachial pain.

Detailed description: The Cervical Lateral Glide (CLG) is a neural tissue mobilization technique capable of achieving a hypoalgesic effect during the onset of cervicobrachial pain symptoms. This happens through a series of complex physiologic interactions which are not fully understood. The CLG Physical therapy technique consists of controlled movements of the cervical and brachial plexus neural tissue. Hypoalgesic effect produced by CLG is associated to an increase in neural tissue mobility, edema, inflammation and intraneural pressure reduction, without any known side effects when applied properly, except for a momentary worsening of symptoms (the only known side effect of CLG), which is an important contrast to the wide and sometimes severe spectrum of side effects derived from drug therapy used to treat cervicobrachial pain.

It is believed that the hypoalgesic effect offered by neural tissue mobilization is a consequence of descending nervous system pain modulation activity and an improvement in the distinct biomechanical properties of the involved neural tissue.Despite the increase in scientific interest in evidence based options to treat pain and neural tissue mobilization techniques there is a current lack of enough controlled double blind clinical trials that measure the effectiveness of neural tissue mobilization techniques such as the CLG and its specific effect over cervicobrachial pain. For this reason the present investigation consisted in the application of a treatment protocol based on CLG neural tissue mobilization in a controlled double blind clinical trial with the aim to assess its clinical effectiveness in treating pain symptoms

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of cervicobrachial pain confirmed by magnetic resonance imaging
* Presence of unilateral symptoms of arm pain, paresthesia or numbness in the upper extremity during at least 3 continuous months previous to the application of treatment.
* Positive results in all of the following tests: Spurling, Distraction, and Upper Limb

Exclusion Criteria:

* Contraindication in the use of nonsteroidal anti inflammatory drugs (NSAIDs)
* The use of any type of treatment, therapy, procedure or drug to relieve pain
* Patients who are under anticonvulsant, antidepressant or psychotropic medication
* Vertebral instability
* Vertebral osteoporosis
* Vertebral or spine infection.
* Neurologic diseases of genetic, infectious or neoplastic origin
* Cervical stenosis myelopathy
* Pregnancy
* Kinesiophobia
* Endocrine disorders and menopause
* History of spine surgery
* Intellectual disability, severe mental illness, intoxication, severe sleep deprivation, Alzheimer's disease.

Primary outcomes:
measure: Change from baseline using the Numeric Rating Scale for Pain at 1 hour
timeFrame: at baseline for both arms and 1 hour after the application of treatment only in the experimental arm, corresponding to intervention days 1, 15 and 30
Secondary outcomes:
measure: Change from baseline of the Physical function involving the affected upper limb using the Quik DASH Scale
timeFrame: at baseline, corresponding to intervention days 1 and 30 of treatment
measure: Cervical Rotation Range of Motion (CROM)
timeFrame: at baseline for both arms and 1 hour after the application of treatment only in the experimental arm, corresponding to intervention days 1 and 30
Other outcomes:
Locations:
city: San Diego
country: Venezuela
facility: "Centro Médico y de Especialidades Pediátricas Dr. José Gregorio Hernández "
state: Carabobo
Study officials:
affiliation: Universidad Europea de Madrid
name: Francisco H Unda, PT, MSc
role: PRINCIPAL_INVESTIGATOR
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