- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05914129
Efficacy of Osteopathic Visceral Treatment in Patients With Chronic Neck Pain
Efficacy of Osteopathic Visceral Treatment on the Diaphragm, Stomach and Liver in Patients With Chronic Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Natália MO Campelo, PhD
- Phone Number: +351 938674365
- Email: ncampelo.estsp.ipp.pt@gmail.com
Study Locations
-
-
-
Porto, Portugal, 4200-072
- Escola Superior da Saúde do Porto
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: 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.
|
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: 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 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: 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.
|
In this group, techniques are the exact same as described previously but only liver and stomach ones will be performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in level of incapacity derived from neck pain 7 days after the intervention
Time Frame: 7 days after the intervention
|
The Neck Disability Index questionnaire (NDI) will be the instrument used to evaluate the level of incapacity caused by neck pain. The questionnaire has 10 questions about the volunteers everyday life activities. There are 6 options to each question and the participant must choose the one that applies the most to their experience. The options selected will account for a score that goes from 0 to 50. The higher the number of the option, the more incapacity is felt and reported by the participant, meaning a worse outcome. This data will be collected by asking the volunteer their preferred option and writing it down. |
7 days after the intervention
|
Change in level of pain throughout the 7 days following the intervention
Time Frame: Once a day for the 7 days after the intervention
|
The pain outcome will be measured according to the volunteers perception of pain in the cervical region by using the Numerical Pain Scale (NPS). This scale ranges from 0 to 10 and the participant must choose one number that best suits their level of current pain, 0 corresponding to "no pain" and 10 being "the worst pain imaginable to that participant". The higher the number, the worse the outcome. This data will be collected by asking the volunteer for the corresponding number and writing it down. |
Once a day for the 7 days after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in perception of the global conditions throughout the 7 days following the intervention
Time Frame: Once a day for the 7 days after the intervention
|
One week after the intervention, the participants must answer the Global Perception of Change Scale (GPCS), which presents 7 options (from 1 to 7). The higher the number of the option, the more change was perceived and reported by the participant, meaning a better outcome. This instrument will guide the researcher to better understand if the intervention resulted in any kind of change to their initial condition. This data will be collected by asking the volunteer their preferred option and writing it down. |
Once a day for the 7 days after the intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Natália MO Campelo, Escola Superior de Saúde do Politecnico do Porto
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OST1-008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Pain
-
University of DeustoUniversity of the Basque Country (UPV/EHU); Osakidetza; Matia FoundationRecruitingCervical Pain | Cervical Radiculopathy | Cervical Radicular PainSpain
-
Afyonkarahisar Health Sciences UniversityCompletedMusculoskeletal Diseases | Cervical Pain | Radiculopathy | Cervical Disc Disease | Cervical Radicular PainTurkey
-
Palo Alto Veterans Institute for ResearchAllerganCompletedSubacute Cervical Pain | Subacute Upper Back Pain
-
Ahram Canadian UniversityRecruiting
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
University of UtahRecruitingCervical Pain | Cervical Facet Joint PainUnited States
-
Fayoum University HospitalCompletedInjection | Intervention | Epidural | CervicalEgypt
-
Jaseng Hospital of Korean MedicineCompletedLumbar and Cervical PainKorea, Republic of
-
Region SkaneUnknownNeck Pain | Cervical Disc Disease | Radiculopathy, Cervical | Cervical Foraminal Stenosis
-
Istanbul Medipol University HospitalCompletedPain | Cervical Radiculopathy | Cervical Disc Disease | Cervical Disc Herniation | Cervical Radicular Pain | Cervical; HerniaTurkey
Clinical Trials on Sham technique
-
University of SalamancaInstituto de Investigación Biomédica de SalamancaRecruitingBruxism | Temporomandibular Joint Disorders | Kinesiophobia | Pain ThresholdSpain
-
Centre hospitalier de l'Université de Montréal...Completed
-
Escola Superior de Tecnologia da Saúde do PortoNot yet recruiting
-
Escola Superior de Tecnologia da Saúde do PortoCompletedLatent Myofascial Trigger Point of Upper Trapezius MusclePortugal
-
Accademia Italiana Medicina OsteopaticaCompleted
-
Kubra KoceCompletedMyofascial Pain Syndrome | Trigger Point Pain, MyofascialTurkey
-
Kahramanmaras Sutcu Imam UniversityNot yet recruiting
-
Helga Cecília Muniz de SouzaUniversidade Federal de PernambucoCompleted
-
Universidade Federal de PernambucoCompleted
-
Ramón Mateos AlpuenteRecruiting