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Cervical PainNCT05914129

Efficacy of Osteopathic Visceral Treatment in Patients With Chronic Neck Pain

A study testing Diaphragm, Stomach and Liver techniques and Stomach and Liver techniques in people with Cervical Pain, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Cervical Pain
What is being tested?
Diaphragm, Stomach and Liver techniques and Stomach and Liver techniques
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 sitePortugal
Study dates
1 Sep 2024to 8 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • Escola Superior da Saúde do Porto

    Porto, 4200-072

Other trials in Portugal

About this study

Official title: Efficacy of Osteopathic Visceral Treatment on the Diaphragm, Stomach and Liver in Patients With Chronic Neck Pain

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

Read the 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).

Conditions
Cervical Pain
Being tested
Diaphragm, Stomach and Liver techniques, Stomach and Liver techniques, Sham technique
Keywords
Chronic Neck Pain, Diaphragm, Manual Therapy, Osteopathy, Visceral Techniques
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diaphragm, Stomach and Liver techniquesOther

    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 techniquesOther

    In this group, techniques are the exact same as described previously but only liver and stomach ones will be performed.

  • Sham techniqueOther

    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.

Study groups in NCT05914129
Study groupRoleWhat they receive
Control Group (GC)Sham comparatorTo 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.
Receives: Other: Sham technique
Experimental Group A (GEA)ExperimentalTo 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.
Receives: Other: Diaphragm, Stomach and Liver techniques
Experimental Group B (GEB)ExperimentalTo 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.
Receives: Other: Stomach and Liver techniques

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in level of incapacity derived from neck pain 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.

    Measured: 7 days after the intervention

  2. Change in level of pain throughout the 7 days following 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.

    Measured: Once a day for the 7 days after the intervention

Secondary outcomes (1)
  1. Change in perception of the global conditions throughout the 7 days following 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.

    Measured: Once a day for the 7 days after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion8 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05914129
Sponsor's protocol ID
OST1-008
Status last verified
Apr 2024
First submitted
13 Jun 2023
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35986986
  • 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.

    PubMed 25175885
  • 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.

    PubMed 34844625
  • 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.

    PubMed 32784959
  • 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.

    PubMed 32507144
  • 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.

    PubMed 28532881
  • 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.

    PubMed 36844992
  • 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.

    PubMed 31726685
  • 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.

    PubMed 33354233
  • 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.

    PubMed 30534176
  • 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.

    PubMed 31191786

Questions about this trial

What is this clinical trial studying?

A study testing Diaphragm, Stomach and Liver techniques and Stomach and Liver techniques in people with Cervical Pain, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Natália MO Campelo, PhD (938674365 ext. +351, ncampelo.estsp.ipp.pt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in level of incapacity derived from neck pain 7 days after the intervention (time frame: 7 days after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05914129, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.

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