Clinical trial NCT02111382: Electroencephalography Activity in Individuals With Nonspecific Chronic Low Back Pain After Cranial Osteopathic Manipulative Treatment
Official title: Electroencephalography Activity in Individuals With Nonspecific Chronic Low Back Pain After Cranial Osteopathic Manipulative Treatment: Study Protocol of a Randomized, Controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
osteopathic manipulations
electroencephalography
Lead sponsor: University of Brasilia
Sponsor class: OTHER
Collaborators: name: University Hospital of Brasília
First posted: 2014-04-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Osteopathic medicine is based on a diagnostic and therapeutic system to treat tissue mobility/ motility dysfunctions in general, using different approaches (depending on the target tissue) known as osteopathic manipulative treatment.

Among all the available techniques those ones addressed to the cranial field are most questioned because of the lack of scientific evidence; but the compression of the 4th ventricle technique has been largely studied in clinical trials. Studies have shown that the technique may affect both central and autonomous nervous system, modulating some reflexes (Traube-Hering baro signal), and modifying brain cortex electrical activity through central sensitization in subjects with chronic low back pain.

Thus, investigators hypothesize that the compression of the 4th ventricle may modulate peak alpha frequency (electroencephalographic assessment) and promote physical relaxation in subjects in vigil.

Detailed description: A randomized controlled crossover trial with blinded assessor was designed to test the hypothesis. A total of 81 participants will be assigned to three treatment conditions, with seven days of washout: compression of the 4th ventricle group; sham compression of the 4th ventricle group; control group (no intervention).

All participants will be recruited at the Outpatient Rehabilitation Service of the University Hospital of Brasília - University of Brasília (Brazil).

Eligibility criteria: Inclusion Criteria:

* Participants over 18 years old with self-reported nonspecific chronic low back pain will be recruited

Exclusion Criteria:

* Participants suffering from secondary chronic low back pain,
* fever, chills, sweating, weight loss, asthenia, anorexia;
* cardiovascular and respiratory symptoms such as chest pain, dyspnea and cough;
* headache, dizziness, lightheadedness, fainting, tremors, dysarthria and aphasia;
* participants who underwent surgery on the spine;
* diagnosis of any neurological, cardiac, respiratory and rheumatic disease;
* regular use of drugs with effects on the central nervous system.

Primary outcomes:
measure: Peak alpha frequency (Electroencephalography)
timeFrame: Baseline, 10 minutes.
Secondary outcomes:
measure: Pain intensity
timeFrame: Baseline, 10 minutes
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: University of Brasilia
state: Distrito Federal
Study officials:
affiliation: Assistant Professor, PhD - Graduate Program in Physical Therapy Universidade de Brasília (UnB) - Faculdade de Ceilândia (FCE)
name: Wagner Martins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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