Clinical trial NCT05914129: Efficacy of Osteopathic Visceral Treatment in Patients With Chronic Neck Pain
Official title: Efficacy of Osteopathic Visceral Treatment on the Diaphragm, Stomach and Liver in Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Pain
Keywords: Chronic Neck Pain
Diaphragm
Manual Therapy
Osteopathy
Visceral Techniques
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to analyze the effects of visceral osteopathic treatment of the diaphragm, stomach and liver in the treatment of chronic neck pain.

Detailed description: Cervical pain is a very common condition, whom can originate from bad posture, cervical tension, anxiety, depression and occupational or sportive activities. The influence of mobility and function changes of the abdominal viscera in the cervical region is a mechanism that is still poorly described in literature.

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).

Eligibility criteria: Inclusion Criteria:

* Pain in the posterior cervical region for more than 3 months;
* Knowing how to read and write;

Exclusion Criteria:

* Recent Cervicothoracic or Thoracoabdominal trauma (less than 6 months);
* 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

Primary outcomes:
measure: Change in level of incapacity derived from neck pain 7 days after the intervention
timeFrame: 7 days after the intervention
measure: Change in level of pain throughout the 7 days following the intervention
timeFrame: Once a day for the 7 days after the intervention
Secondary outcomes:
measure: Change in perception of the global conditions throughout the 7 days following the intervention
timeFrame: Once a day for the 7 days after the intervention
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior da Saúde do Porto
Study officials:
affiliation: Escola Superior de Saúde do Politécnico do Porto
name: Natália MO Campelo
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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