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

August 12, 2023 updated by: Wagner Rodrigues Martins, University of Brasilia

Electroencephalography Activity in Individuals With Nonspecific Chronic Low Back Pain After Cranial Osteopathic Manipulative Treatment: Study Protocol of a Randomized, Controlled Crossover Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 72220-900
        • University of Brasilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CV4 (4th ventricle technique) technique
Will be conduced a real cranial osteopathic medicine technique.
Other: CV4 Cranial (4th ventricle technique) Osteopathic Manipulative

The participant will be in supine position during the whole procedure. The practitioner sits behind the participant's head, contacts participant's lateral protuberances of the squama occipitalis (medially to the occipitomastoid suture) with the thenar eminence of both hands.

When the practitioner feels the PRM (a pulsating rhythm caused by liquor production and reabsorption), the flexion phase will be resisted and the extension phase exaggerated. The compressive force is held until the PRM stops (event known as 'Still point'). The compression will be held until the practitioner feels PRM gradual return; the compression will be slowly diminished, and then, the practitioner remove the hands from the occipital bone, laying the participant's head on the table.

The CV4 technique will be performed by an osteopath D.O. - member of the Brazilian Register of Osteopaths.

Other Names:
  • 4th ventricle technique
Sham Comparator: CV4 sham
This group will received only a sham manual therapy technique.
Other: CV4 (4th ventricle technique) manual therapy sham technique

The participant will be in supine position and the practitioner will be seated behind the participant's head. The practitioner places the fingers (2nd to 5th) under the occipital bone, touching only the squama occipitalis. The practitioner will hold this position for 5 minutes, and after this period the participant's head will be placed on the table.

The CV4 sham will be performed by a registered physiotherapist.
No Intervention: Control
The participants will be in supine position for 5 minutes without any visual or verbal contact.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak alpha frequency (Electroencephalography)
Time Frame: Baseline, 10 minutes.
Baseline: before intervention. 10 minutes: 10 minutes after intervention.
Baseline, 10 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Baseline, 10 minutes
Baseline: before intervention. 10 minutes: 10 minutes after intervention. Pain intensity: 0-10 Numeric Pain Rating Scale
Baseline, 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Collaborators

University Hospital of Brasília

Investigators

  • Principal Investigator: Wagner Martins, PhD, Assistant Professor, PhD - Graduate Program in Physical Therapy Universidade de Brasília (UnB) - Faculdade de Ceilândia (FCE)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2018

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimated)

April 11, 2014

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 12, 2023

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cv4-2014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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