Electroencephalography Activity in Individuals With Nonspecific Chronic Low Back Pain After Cranial Osteopathic Manipulative Treatment
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| ClinicalTrials.gov Identifier: NCT02111382 |
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Recruitment Status :
Suspended
(The pilot study demonsttated some new concerns about methodology. So we decided to suspended temporarily to added new settings to study design.)
First Posted : April 11, 2014
Last Update Posted : January 13, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Low Back Pain | Other: CV4 Cranial (4th ventricle technique) Osteopathic Manipulative Other: CV4 (4th ventricle technique) manual therapy sham technique | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 81 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | 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 |
| Actual Study Start Date : | January 31, 2018 |
| Actual Primary Completion Date : | June 30, 2018 |
| Estimated Study Completion Date : | December 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: CV4 (4th ventricle technique) technique
Will be conduced a real cranial osteopathic medicine technique.
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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 Name: 4th ventricle technique |
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Sham Comparator: CV4 sham
This group will received only a sham manual therapy technique.
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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. |
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No Intervention: Control
The participants will be in supine position for 5 minutes without any visual or verbal contact.
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- Peak alpha frequency (Electroencephalography) [ Time Frame: Baseline, 10 minutes. ]Baseline: before intervention. 10 minutes: 10 minutes after intervention.
- Pain intensity [ Time Frame: Baseline, 10 minutes ]Baseline: before intervention. 10 minutes: 10 minutes after intervention. Pain intensity: 0-10 Numeric Pain Rating Scale
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111382
| Brazil | |
| University of Brasilia | |
| Brasilia, Distrito Federal, Brazil, 72220-900 | |
| Principal Investigator: | Wagner Martins, PhD | Assistant Professor, PhD - Graduate Program in Physical Therapy Universidade de Brasília (UnB) - Faculdade de Ceilândia (FCE) |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wagner Rodrigues Martins, Professor, PhD, University of Brasilia |
| ClinicalTrials.gov Identifier: | NCT02111382 |
| Other Study ID Numbers: |
cv4-2014 |
| First Posted: | April 11, 2014 Key Record Dates |
| Last Update Posted: | January 13, 2021 |
| Last Verified: | January 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Low back pain osteopathic manipulations electroencephalography |
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Back Pain Low Back Pain Pain Neurologic Manifestations |