Electroencephalography Activity in Individuals With Nonspecific Chronic Low Back Pain After Cranial Osteopathic Manipulative Treatment

University of Brasilia

Status: Withdrawn

Conditions: Low Back Pain

Treatments: Other: CV4 Cranial (4th ventricle technique) Osteopathic Manipulative; Other: CV4 (4th ventricle technique) manual therapy sham technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02111382

cv4-2014

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 3 patient groups

CV4 (4th ventricle technique) technique

Experimental group

Description:

Will be conduced a real cranial osteopathic medicine technique.

Treatment:

Other: CV4 Cranial (4th ventricle technique) Osteopathic Manipulative

CV4 sham

Sham Comparator group

Description:

This group will received only a sham manual therapy technique.

Treatment:

Other: CV4 (4th ventricle technique) manual therapy sham technique

Control

No Intervention group

Description:

The participants will be in supine position for 5 minutes without any visual or verbal contact.