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Visceral Manipulation Treatment to Patients With Non-specific Neck Pain With Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT03043625
Recruitment Status : Completed
First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Collaborators:
Andréia Cristina de Oliveira Silva
Claudia Santos Oliveira
Daniela Aparecida Biasotto-Gonzalez
Marco Antônio Fumagalli
Cid André Fidelis de Paula Gomes
Information provided by (Responsible Party):
Fabiano Politti, University of Nove de Julho

Brief Summary:

Background: Non-specific neck pain (NS-NP) is characterized by pain in structures located in the region between the superior nuchal line and the spinal process of the first thoracic vertebra, without association with any specific systemic disease provided by multifactorial and/or little known causes.

Objective: The objective of the present study will be to verify the clinical effects of MV through visceral nociceptive inhibition in NS-NP patients with functional dyspepsia.

Methods: In this study sixty NS-NP patients with functional dyspepsia (age: 18 and 50 years) will be randomized in into two groups: visceral manipulation group (VMG) (n =30) and control group (CG) (n =30). The VMG will be treated with visceral manipulation to the stomach and liver wile CG received placebo treatment. The immediate effects and 7 days after treatment will be evaluated through pain, cervical range, and electromyographic activity of the upper trapezius.


Condition or disease Intervention/treatment Phase
Neck Pain Functional Dyspepsia Other: Visceral manipulation Other: Control group (CG) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blinded, sham-controlled, study
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Visceral Manipulation on Electromyographic Activity of the Upper Trapezius Muscle, Cervical Range and Pain in Patients With Non-specific Neck Pain With Functional Dyspepsia: A Randomized, Double-blinded, Sham-controlled, Study
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : January 30, 2017
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Visceral manipulation Group (VMG)
The VMG wil be treated with visceral manipulation to the stomach and liver
Other: Visceral manipulation
Participants will be instructed to lie down comfortably on a stretcher in the supine position, with lower limbs flexed and abdomen exposed, and the physiotherapist positioned to the right side of the patient. The therapeutic intervention will be began with the left hand of the physiotherapist in contact with the lower region of the stomach, to which a force will be applied so that the organ was moved in an upper and lateral left direction while the right hand controlled and directed the knees of the patient to the right side until the moment when the physiotherapist notice an increase in tension in the stomach region. For the liver manipulation, the same procedures will be followed, however, with contact in the right epigastric region and the knees directed to the left side. The same position will be maintained for each organ treated until the physiotherapist could feel, through touch, a decrease in the tension of the viscera. The mean treatment time will 5 minutes.

Placebo Comparator: Control group (CG)
The CG will be received placebo treatment. In the placebo treatment, the therapist should place the hands over the navel region without exerting any local tension for 1 minute.
Other: Control group (CG)
The CG will be received placebo treatment. In the placebo treatment, the therapist should place the hands over the navel region without exerting any local tension for 1 minute.




Primary Outcome Measures :
  1. Pain intensity assessed with Numerical Rating Scale [ Time Frame: 12 months ]
    Numerical rating scale (NRS) (11 point; 0: no pain, 10: the worst possible pain imaginable) translated and cross-culturally adapted for the Brazilian population

  2. Pain area documented on a body chart [ Time Frame: 12 months ]
    Pain area will documented on a body chart. The drawings will be subsequently digitized and pain areas will be measured using open source software named ImageJ (version 1.43, National Institutes of Health, Bethesda, Maryland).


Secondary Outcome Measures :
  1. Electromyography [ Time Frame: 12 months ]
    The sEMG signal of the upper trapezius muscle will be recorded on the side with the greatest self-reported pain.

  2. Cervical range of motion [ Time Frame: 12 months ]
    A flexometer (Sami ®) will be used to verify cervical range of motion (ROM) of the flexion/extension, right and left lateral flexion and rotation.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • history of neck pain for a minimal period of the three months;
  • neck with restricted movement (active or passive) in at least one direction;
  • Neck Disability Index considering score range of 11-24 (score out of a 50) ;
  • numerical rating scale (NRS) for perceived pain intensity considering 3-7 points on an 11-point;
  • Presence of symptoms related to functional dyspepsia, according to the Rome III diagnostic criteria: uncomfortable postprandial fullness, early satiety, epigastric pain and epigastric burning, accompanied by no evidence of structural disease capable of explaining the symptoms .

Exclusion Criteria:

  • Individuals with history of neurological disorders (i.e., irradiated pain) or neck surgery; systemic disease; connective tissue disorder and herniated disc;
  • current pregnancy;
  • medical diagnosis of fibromyalgia;
  • physical therapy treatment with, massage, or acupuncture in the previous two weeks;
  • use of analgesic, muscle relaxant, psychotropic agent, or anti-inflammatory agent in the previous three days;
  • chronic neck pain resulting from a traumatic incident; chronic musculoskeletal condition (e.g., muscular disorder, polyarthritis).

Publications of Results:
Barral JP, Mercier P. Visceral Manipulation. Eastland Press; 2005.

Other Publications:
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Responsible Party: Fabiano Politti, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT03043625     History of Changes
Other Study ID Numbers: VM-2016
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will not be shared with other researchers. The results of the study will be published as a manuscript in a scientific journal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fabiano Politti, University of Nove de Julho:
Neck pain
visceral manipulation
functional dyspepsia
electromyography
pain

Additional relevant MeSH terms:
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Neck Pain
Dyspepsia
Gastritis
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases