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

Primary Purpose

Low Back Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CV4 Cranial (4th ventricle technique) Osteopathic Manipulative
CV4 (4th ventricle technique) manual therapy sham technique
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, osteopathic manipulations, electroencephalography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Brasilia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

CV4 (4th ventricle technique) technique

CV4 sham

Control

Arm Description

Will be conduced a real cranial osteopathic medicine technique.

This group will received only a sham manual therapy technique.

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

Outcomes

Primary Outcome Measures

Peak alpha frequency (Electroencephalography)
Baseline: before intervention. 10 minutes: 10 minutes after intervention.

Secondary Outcome Measures

Pain intensity
Baseline: before intervention. 10 minutes: 10 minutes after intervention. Pain intensity: 0-10 Numeric Pain Rating Scale

Full Information

First Posted
March 28, 2014
Last Updated
August 12, 2023
Sponsor
University of Brasilia
Collaborators
University Hospital of Brasília
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1. Study Identification

Unique Protocol Identification Number
NCT02111382
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The pilot study demonsttated some new concerns about methodology. So we decided to suspended temporarily to added new settings to study design.
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Brasilia
Collaborators
University Hospital of Brasília

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, osteopathic manipulations, electroencephalography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CV4 (4th ventricle technique) technique
Arm Type
Experimental
Arm Description
Will be conduced a real cranial osteopathic medicine technique.
Arm Title
CV4 sham
Arm Type
Sham Comparator
Arm Description
This group will received only a sham manual therapy technique.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The participants will be in supine position for 5 minutes without any visual or verbal contact.
Intervention Type
Other
Intervention Name(s)
CV4 Cranial (4th ventricle technique) Osteopathic Manipulative
Other Intervention Name(s)
4th ventricle technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
CV4 (4th ventricle technique) manual therapy sham technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peak alpha frequency (Electroencephalography)
Description
Baseline: before intervention. 10 minutes: 10 minutes after intervention.
Time Frame
Baseline, 10 minutes.
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Baseline: before intervention. 10 minutes: 10 minutes after intervention. Pain intensity: 0-10 Numeric Pain Rating Scale
Time Frame
Baseline, 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wagner Martins, PhD
Organizational Affiliation
Assistant Professor, PhD - Graduate Program in Physical Therapy Universidade de Brasília (UnB) - Faculdade de Ceilândia (FCE)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Brasilia
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
72220-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22182954
Citation
Jakel A, von Hauenschild P. Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. J Am Osteopath Assoc. 2011 Dec;111(12):685-93.
Results Reference
background
PubMed Identifier
16080794
Citation
Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005 Aug 4;6:43. doi: 10.1186/1471-2474-6-43.
Results Reference
background
PubMed Identifier
11329812
Citation
Nelson KE, Sergueef N, Lipinski CM, Chapman AR, Glonek T. Cranial rhythmic impulse related to the Traube-Hering-Mayer oscillation: comparing laser-Doppler flowmetry and palpation. J Am Osteopath Assoc. 2001 Mar;101(3):163-73.
Results Reference
background
PubMed Identifier
22182951
Citation
Shi X, Rehrer S, Prajapati P, Stoll ST, Gamber RG, Downey HF. Effect of cranial osteopathic manipulative medicine on cerebral tissue oxygenation. J Am Osteopath Assoc. 2011 Dec;111(12):660-6.
Results Reference
background
PubMed Identifier
24147129
Citation
Huneke NT, Brown CA, Burford E, Watson A, Trujillo-Barreto NJ, El-Deredy W, Jones AK. Experimental placebo analgesia changes resting-state alpha oscillations. PLoS One. 2013 Oct 11;8(10):e78278. doi: 10.1371/journal.pone.0078278. eCollection 2013.
Results Reference
background
PubMed Identifier
20920810
Citation
Field T, Diego M, Hernandez-Reif M. Tai chi/yoga effects on anxiety, heartrate, EEG and math computations. Complement Ther Clin Pract. 2010 Nov;16(4):235-8. doi: 10.1016/j.ctcp.2010.05.014. Epub 2010 Jun 29.
Results Reference
background
PubMed Identifier
15750368
Citation
Cutler MJ, Holland BS, Stupski BA, Gamber RG, Smith ML. Cranial manipulation can alter sleep latency and sympathetic nerve activity in humans: a pilot study. J Altern Complement Med. 2005 Feb;11(1):103-8. doi: 10.1089/acm.2005.11.103.
Results Reference
background
PubMed Identifier
23768271
Citation
Miana L, Bastos VH, Machado S, Arias-Carrion O, Nardi AE, Almeida L, Ribeiro P, Machado D, King H, Silva JG. Changes in alpha band activity associated with application of the compression of fourth ventricular (CV-4) osteopathic procedure: a qEEG pilot study. J Bodyw Mov Ther. 2013 Jul;17(3):291-6. doi: 10.1016/j.jbmt.2012.10.002. Epub 2012 Nov 16.
Results Reference
background
PubMed Identifier
23532434
Citation
Jensen MP, Gertz KJ, Kupper AE, Braden AL, Howe JD, Hakimian S, Sherlin LH. Steps toward developing an EEG biofeedback treatment for chronic pain. Appl Psychophysiol Biofeedback. 2013 Jun;38(2):101-8. doi: 10.1007/s10484-013-9214-9.
Results Reference
background
PubMed Identifier
10590970
Citation
Klem GH, Luders HO, Jasper HH, Elger C. The ten-twenty electrode system of the International Federation. The International Federation of Clinical Neurophysiology. Electroencephalogr Clin Neurophysiol Suppl. 1999;52:3-6. No abstract available.
Results Reference
background
PubMed Identifier
26165865
Citation
Martins WR, Diniz LR, Blasczyk JC, Lagoa KF, Thomaz S, Rodrigues ME, de Oliveira RJ, Bonini-Rocha AC. Immediate changes in electroencephalography activity in individuals with nonspecific chronic low back pain after cranial osteopathic manipulative treatment: study protocol of a randomized, controlled crossover trial. BMC Complement Altern Med. 2015 Jul 13;15:223. doi: 10.1186/s12906-015-0732-2.
Results Reference
derived
Links:
URL
http://www.unb.br
Description
University of Brasilia
URL
http://www.registrodososteopatas.com.br
Description
Brazilian Register of Osteopaths

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

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