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

Not Applicable

Withdrawn

• Conditions: Low Back Pain
• Interventions: Other: CV4 Cranial (4th ventricle technique) Osteopathic Manipulative; Other: CV4 (4th ventricle technique) manual therapy sham technique

• Registration Number: NCT02111382
• Lead Sponsor: University of Brasilia

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).

Study Timeline

• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-11
• Status Verified: 2018-01
• Study Start: 2018-01-31
• Primary Completion: 2018-06-30
• Study Completion: 2018-12-31
• Last Update Submitted: 2023-08-12
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CV4 (4th ventricle technique) technique	CV4 Cranial (4th ventricle technique) Osteopathic Manipulative	Will be conduced a real cranial osteopathic medicine technique.
CV4 sham	CV4 (4th ventricle technique) manual therapy sham technique	This group will received only a sham manual therapy technique.

Primary Outcome Measures

Name	Time	Method
Peak alpha frequency (Electroencephalography)	Baseline, 10 minutes.	Baseline: before intervention. 10 minutes: 10 minutes after intervention.

Secondary Outcome Measures

Name	Time	Method
Pain intensity	Baseline, 10 minutes	Baseline: before intervention. 10 minutes: 10 minutes after intervention. Pain intensity: 0-10 Numeric Pain Rating Scale

Trial Locations

Locations (1)

University of Brasilia; 🇧🇷 Brasilia, Distrito Federal, Brazil