Low Back PainNCT02111382

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

A study testing CV4 Cranial (4th ventricle technique) Osteopathic Manipulative in people with Low Back Pain, run by University of Brasilia at 1 site in Brazil.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain
What is being tested?: CV4 Cranial (4th ventricle technique) Osteopathic Manipulative
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteBrazil
Study dates: 31 Jan 2018to 31 Dec 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

University of Brasilia
Brasília, Federal District, 72220-900

Other trials in Brazil

About this study

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

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.

Read the 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).

Conditions: Low Back Pain
Being tested: CV4 Cranial (4th ventricle technique) Osteopathic Manipulative, CV4 (4th ventricle technique) manual therapy sham technique
Keywords: Low back pain, osteopathic manipulations, electroencephalography
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CV4 Cranial (4th ventricle technique) Osteopathic ManipulativeOther
Also called 4th ventricle technique
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.
CV4 (4th ventricle technique) manual therapy sham techniqueOther
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.

Study groups in NCT02111382
Study group	Role	What they receive
CV4 (4th ventricle technique) technique	Experimental	Will be conduced a real cranial osteopathic medicine technique. Receives: Other: CV4 Cranial (4th ventricle technique) Osteopathic Manipulative
CV4 sham	Sham comparator	This group will received only a sham manual therapy technique. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 201831 Dec 2018

First posted11 Apr 2014 (estimated)
Study start31 Jan 2018
Primary completion30 Jun 2018
Study completion31 Dec 2018

Why it stopped: The pilot study demonsttated some new concerns about methodology. So we decided to suspended temporarily to added new settings to study design.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02111382
Sponsor's protocol ID: cv4-2014
Status last verified: Jan 2018
First submitted: 28 Mar 2014
Last updated: 15 Aug 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 22182954
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.
PubMed 16080794
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.
PubMed 11329812
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.
PubMed 22182951
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.
PubMed 24147129
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.
PubMed 20920810
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.
PubMed 15750368
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.
PubMed 23768271
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.
PubMed 23532434
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.
PubMed 10590970
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.
PubMed 26165865

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Nonspecific Low Back Pain
Not yet recruiting
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02111382
Acronym / sponsor ID: cv4-2014
Conditions: Low Back Pain
Keywords: Low back pain, osteopathic manipulations, electroencephalography
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The pilot study demonsttated some new concerns about methodology. So we decided to suspended temporarily to added new settings to study design.
Enrolment: 0 participants (actual)
Lead sponsor: University of BrasiliaUniversity, hospital or other
Collaborators: University Hospital of Brasília
Study start: 31 Jan 2018 (actual)
Primary completion: 30 Jun 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 11 Apr 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

All participants will be recruited at the Outpatient Rehabilitation Service of the University Hospital of Brasília - University of Brasília (Brazil).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
CV4 (4th ventricle technique) technique	Experimental	Other: CV4 Cranial (4th ventricle technique) Osteopathic ManipulativeWill be conduced a real cranial osteopathic medicine technique.
CV4 sham	Sham comparator	Other: CV4 (4th ventricle technique) manual therapy sham techniqueThis group will received only a sham manual therapy technique.
Control	No intervention	–The participants will be in supine position for 5 minutes without any visual or verbal contact.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CV4 Cranial (4th ventricle technique) Osteopathic ManipulativeAlso: 4th ventricle techniqueThe 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	CV4 (4th ventricle technique) technique
CV4 (4th ventricle technique) manual therapy sham techniqueThe 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.	Other	CV4 sham

Primary outcome

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

1 secondary outcome

Pain intensity
Time frame: Baseline, 10 minutes

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
Background: PubMed 22182954Jakel A, von Hauenschild P. Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. J Am Osteopath Assoc. 2011 Dec;111(12):685-93.
Background: PubMed 16080794Licciardone 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.
Background: PubMed 11329812Nelson 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.
Background: PubMed 22182951Shi 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.
Background: PubMed 24147129Huneke 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.
Background: PubMed 20920810Field 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.
Background: PubMed 15750368Cutler 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.
Background: PubMed 23768271Miana 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.
Background: PubMed 23532434Jensen 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.
Background: PubMed 10590970Klem 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.
Derived from this study: PubMed 26165865Martins 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.
University of BrasiliaLink provided by the sponsor.
Brazilian Register of OsteopathsLink provided by the sponsor.
University Hospital of BrasiliaLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wagner Martins, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CV4 Cranial (4th ventricle technique) Osteopathic Manipulative in people with Low Back Pain, run by University of Brasilia at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak alpha frequency (Electroencephalography) (time frame: Baseline, 10 minutes.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02111382, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.