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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02111382
• Other study ID #: cv4-2014
• Status: Withdrawn
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2018
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	University of Brasilia	Brasilia	Distrito Federal

Sponsors (2)

Lead Sponsor	Collaborator
University of Brasilia	University Hospital of Brasília

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak alpha frequency (Electroencephalography)	Baseline: before intervention. 10 minutes: 10 minutes after intervention.	Baseline, 10 minutes.
Secondary	Pain intensity	Baseline: before intervention. 10 minutes: 10 minutes after intervention. Pain intensity: 0-10 Numeric Pain Rating Scale	Baseline, 10 minutes

External Links

•   Brazilian Register of Osteopaths
•   University of Brasilia