Electroencephalography Activity in Individuals With Nonspecific Chronic Low Back Pain After Cranial Osteopathic Manipulative Treatment: Study Protocol of a Randomized, Controlled Crossover Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- University of Brasilia
- Locations
- 1
- Primary Endpoint
- Peak alpha frequency (Electroencephalography)
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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).
Investigators
Wagner Rodrigues Martins
Professor, PhD
University of Brasilia
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.
Outcomes
Primary Outcomes
Peak alpha frequency (Electroencephalography)
Time Frame: Baseline, 10 minutes.
Baseline: before intervention. 10 minutes: 10 minutes after intervention.
Secondary Outcomes
- Pain intensity(Baseline, 10 minutes)