Efficacy of Osteopathic Visceral Treatment in Patients With Chronic Neck Pain
NCT ID: NCT05914129
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
45 participants
INTERVENTIONAL
2024-09-01
2024-12-08
Brief Summary
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Detailed Description
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It is expected to find, through mechanical and neural pathways, that the visceral osteopathy treatment will have some effect on chronic neck pain.
This study intends to check the effects of the diaphragm stretching, inferior mobilization of the stomach and liver pump techniques (restoring mobility and normalizing function of the viscera) on the neck region, by employing some questionnaires/instruments.
During the present study, the effects of the visceral techniques will be analyzed in the following variables: Neck Disability Index (NDI), Numeric Pain Scale (NPS or END) and Global Pain Scale (GPS or EPGM).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control Group (GC)
To each volunteer, after 2 questionnaires, sham techniques will be performed to this group. The investigator will mimic the technique contacts without actually performing any type of tissue traction or compression, maintaining contact for the same amount of time described in the refered techniques. Following the technique, volunteers will answer the same 2 questionnaires shown previously.
Sham technique
In the sham group, manual contact without any therapeutic intention will be performed in the same regions as the experimental groups. This contact will be maintained during the same amount of time as for the experimental group A.
Experimental Group A (GEA)
To each volunteer, after 2 questionnaires, Diaphragm Stretching, Lower stomach mobilization and Liver pump techniques will be performed to this group. The diaphragm technique is performed 2 times with 1 minute interval, with the duration of 10 respiratory cycles. The lower stomach mobilization and liver pump techniques are performed one time, for 5 minutes each. Following the technique, volunteers will answer the same 2 questionnaires shown previously.
Diaphragm, Stomach and Liver techniques
Diaphragm Stretching:
The participant is seating down and the researcher will be behind, placing their hands on the inferior costal border. Cephalic traction is performed during inhalation, remaining during exhalation. Procedure is repeated 2 times, for 10 respiratory cycles, with 1-minute intervals.
Inferior Mobilization of the Stomach:
The participant is seating down with slight flexion of the torso, while the investigator stands behind them, placing the thumbs on the epigastric region. The volunteer will extend their body while the researcher performs a caudal traction. This procedure lasts 5 minutes.
Liver Pump:
Participant is laying on their back, and the investigator is standing on the participants side. The researcher places one hand on the right side inferior costal border posteriorly and the other one bellow the costal border anteriorly. Researcher compresses during exhalation and releases their hands abruptly during inhalation. This procedure lasts 5 minutes.
Experimental Group B (GEB)
To each volunteer, after 2 questionnaires, Lower stomach mobilization and Liver pump techniques will be performed to this group. These 2 techniques are the same ones as described for the experimental group A. Following the technique, volunteers will answer the same 2 questionnaires shown previously.
Stomach and Liver techniques
In this group, techniques are the exact same as described previously but only liver and stomach ones will be performed.
Interventions
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Diaphragm, Stomach and Liver techniques
Diaphragm Stretching:
The participant is seating down and the researcher will be behind, placing their hands on the inferior costal border. Cephalic traction is performed during inhalation, remaining during exhalation. Procedure is repeated 2 times, for 10 respiratory cycles, with 1-minute intervals.
Inferior Mobilization of the Stomach:
The participant is seating down with slight flexion of the torso, while the investigator stands behind them, placing the thumbs on the epigastric region. The volunteer will extend their body while the researcher performs a caudal traction. This procedure lasts 5 minutes.
Liver Pump:
Participant is laying on their back, and the investigator is standing on the participants side. The researcher places one hand on the right side inferior costal border posteriorly and the other one bellow the costal border anteriorly. Researcher compresses during exhalation and releases their hands abruptly during inhalation. This procedure lasts 5 minutes.
Stomach and Liver techniques
In this group, techniques are the exact same as described previously but only liver and stomach ones will be performed.
Sham technique
In the sham group, manual contact without any therapeutic intention will be performed in the same regions as the experimental groups. This contact will be maintained during the same amount of time as for the experimental group A.
Eligibility Criteria
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Inclusion Criteria
* Knowing how to read and write;
Exclusion Criteria
* Surgical procedure in the cervical region less than 6 months ago
* Surgical procedure in the abdominal region less than 6 months ago;
* Diagnosis of disc disease/radiculopathy;
* Rheumatic and/or neurological disease;
* Pregnancy status
18 Years
60 Years
ALL
Yes
Sponsors
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Escola Superior de Tecnologia da Saúde do Porto
OTHER
Responsible Party
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Natália Maria Oliveira Campelo
Professor
Principal Investigators
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Natália MO Campelo
Role: PRINCIPAL_INVESTIGATOR
Escola Superior de Saúde do Politécnico do Porto
Locations
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Escola Superior da Saúde do Porto
Porto, , Portugal
Countries
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Central Contacts
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References
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Dal Farra F, Buffone F, Risio RG, Tarantino AG, Vismara L, Bergna A. Effectiveness of osteopathic interventions in patients with non-specific neck pain: A systematic review and meta-analysis. Complement Ther Clin Pract. 2022 Nov;49:101655. doi: 10.1016/j.ctcp.2022.101655. Epub 2022 Aug 11.
Franke H, Franke JD, Fryer G. Osteopathic manipulative treatment for nonspecific low back pain: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2014 Aug 30;15:286. doi: 10.1186/1471-2474-15-286.
Galaasen Bakken A, Eklund A, Hallman DM, Axen I. The effect of spinal manipulative therapy and home stretching exercises on heart rate variability in patients with persistent or recurrent neck pain: a randomized controlled trial. Chiropr Man Therap. 2021 Nov 29;29(1):48. doi: 10.1186/s12998-021-00406-0.
Gomez F, Escriba P, Oliva-Pascual-Vaca J, Mendez-Sanchez R, Puente-Gonzalez AS. Immediate and Short-Term Effects of Upper Cervical High-Velocity, Low-Amplitude Manipulation on Standing Postural Control and Cervical Mobility in Chronic Nonspecific Neck Pain: A Randomized Controlled Trial. J Clin Med. 2020 Aug 10;9(8):2580. doi: 10.3390/jcm9082580.
Groisman S, Malysz T, de Souza da Silva L, Rocha Ribeiro Sanches T, Camargo Bragante K, Locatelli F, Pontel Vigolo C, Vaccari S, Homercher Rosa Francisco C, Monteiro Steigleder S, Jotz GP. Osteopathic manipulative treatment combined with exercise improves pain and disability in individuals with non-specific chronic neck pain: A pragmatic randomized controlled trial. J Bodyw Mov Ther. 2020 Apr;24(2):189-195. doi: 10.1016/j.jbmt.2019.11.002. Epub 2019 Nov 13.
McCoss CA, Johnston R, Edwards DJ, Millward C. Preliminary evidence of Regional Interdependent Inhibition, using a 'Diaphragm Release' to specifically induce an immediate hypoalgesic effect in the cervical spine. J Bodyw Mov Ther. 2017 Apr;21(2):362-374. doi: 10.1016/j.jbmt.2016.08.015. Epub 2016 Sep 9.
Melo TM, Cunha FLL, Bezerra LMR, Salemi M, de Albuquerque VA, de Alencar GG, de Siqueira GR. Abdominal and Diaphragmatic Mobility in Adults With Chronic Gastritis: A Cross-Sectional Study. J Chiropr Med. 2023 Mar;22(1):11-19. doi: 10.1016/j.jcm.2022.05.004. Epub 2022 Jul 20.
Oliva-Pascual-Vaca A, Gonzalez-Gonzalez C, Oliva-Pascual-Vaca J, Pina-Pozo F, Ferragut-Garcias A, Fernandez-Dominguez JC, Heredia-Rizo AM. Visceral Origin: An Underestimated Source of Neck Pain. A Systematic Scoping Review. Diagnostics (Basel). 2019 Nov 12;9(4):186. doi: 10.3390/diagnostics9040186.
Rotter G, Fernholz I, Binting S, Keller T, Roll S, Kass B, Reinhold T, Willich SN, Schmidt A, Brinkhaus B. The effect of osteopathic medicine on pain in musicians with nonspecific chronic neck pain: a randomized controlled trial. Ther Adv Musculoskelet Dis. 2020 Dec 10;12:1759720X20979853. doi: 10.1177/1759720X20979853. eCollection 2020.
Silva ACO, Biasotto-Gonzalez DA, Oliveira FHM, Andrade AO, Gomes CAFP, Lanza FC, Amorim CF, Politti F. Effect of Osteopathic Visceral Manipulation on Pain, Cervical Range of Motion, and Upper Trapezius Muscle Activity in Patients with Chronic Nonspecific Neck Pain and Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Pilot Study. Evid Based Complement Alternat Med. 2018 Nov 11;2018:4929271. doi: 10.1155/2018/4929271. eCollection 2018.
Silva ACO, Oliveira CS, Biasotto-Gonzalez DA, Fumagalli MA, Politti F. Visceral Manipulation Decreases Pain, Increases Cervical Mobility and Electromyographic Activity of the Upper Trapezius Muscle in Non-Specific Neck Pain Subjects with Functional Dyspepsia: Two Case Reports. Int J Ther Massage Bodywork. 2019 Jun 1;12(2):25-30. eCollection 2019 Jun.
Other Identifiers
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OST1-008
Identifier Type: -
Identifier Source: org_study_id
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