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

NCT02111382 | Withdrawn DMC

• 1 other identifier: cv4-2014
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low back pain; osteopathic manipulations; electroencephalography

Outcome Measures

Primary Outcomes (1)

• Peak alpha frequency (Electroencephalography)

  Baseline: before intervention. 10 minutes: 10 minutes after intervention.

  Baseline, 10 minutes.

Secondary Outcomes (1)

• Pain intensity

  Baseline, 10 minutes

Study Arms (3)

CV4 (4th ventricle technique) technique

EXPERIMENTAL

Will be conduced a real cranial osteopathic medicine technique.

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

CV4 sham

SHAM COMPARATOR

This group will received only a sham manual therapy technique.

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

Control

NO INTERVENTION

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

Interventions

CV4 Cranial (4th ventricle technique) Osteopathic Manipulative OTHER

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.

Also known as: 4th ventricle technique

CV4 (4th ventricle technique) technique

CV4 (4th ventricle technique) manual therapy sham technique OTHER

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.

CV4 sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants over 18 years old with self-reported nonspecific chronic low back pain will be recruited

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Brasilia: lead
• University Hospital of Brasília: collaborator

Study Sites (1)

University of Brasilia

Brasília, Federal District, 72220-900, Brazil

Location

Related Publications (11)

• 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.

  PMID: 22182954 BACKGROUND

• 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.

  PMID: 16080794 BACKGROUND

• 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.

  PMID: 11329812 BACKGROUND

• 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.

  PMID: 22182951 BACKGROUND

• 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.

  PMID: 24147129 BACKGROUND

• 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.

  PMID: 20920810 BACKGROUND

• 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.

  PMID: 15750368 BACKGROUND

• 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.

  PMID: 23768271 BACKGROUND

• 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.

  PMID: 23532434 BACKGROUND

• 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.

  PMID: 10590970 BACKGROUND

• 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.

  PMID: 26165865 DERIVED

Related Links

• University of Brasilia
• Brazilian Register of Osteopaths

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wagner Martins, PhD

  Assistant Professor, PhD - Graduate Program in Physical Therapy Universidade de Brasília (UnB) - Faculdade de Ceilândia (FCE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 11, 2014
• Study Start: January 31, 2018
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2018
• Last Updated: August 15, 2023

Record last verified: 2018-01

Locations

BR (1)