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

Primary Purpose

Neck Pain, Functional Dyspepsia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Visceral manipulation
Control group (CG)
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck pain, visceral manipulation, functional dyspepsia, electromyography, pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Visceral manipulation Group (VMG)

    Control group (CG)

    Arm Description

    The VMG wil be treated with visceral manipulation to the stomach and liver

    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.

    Outcomes

    Primary Outcome Measures

    Pain intensity assessed with Numerical Rating Scale
    Numerical rating scale (NRS) (11 point; 0: no pain, 10: the worst possible pain imaginable) translated and cross-culturally adapted for the Brazilian population
    Pain area documented on a body chart
    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

    Electromyography
    The sEMG signal of the upper trapezius muscle will be recorded on the side with the greatest self-reported pain.
    Cervical range of motion
    A flexometer (Sami ®) will be used to verify cervical range of motion (ROM) of the flexion/extension, right and left lateral flexion and rotation.

    Full Information

    First Posted
    February 1, 2017
    Last Updated
    February 3, 2017
    Sponsor
    University of Nove de Julho
    Collaborators
    Andréia Cristina de Oliveira Silva, Claudia Santos Oliveira, Daniela Aparecida Biasotto-Gonzalez, Marco Antônio Fumagalli, Cid André Fidelis de Paula Gomes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03043625
    Brief Title
    Visceral Manipulation Treatment to Patients With Non-specific Neck Pain With Functional Dyspepsia
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    January 30, 2017 (Actual)
    Study Completion Date
    February 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho
    Collaborators
    Andréia Cristina de Oliveira Silva, Claudia Santos Oliveira, Daniela Aparecida Biasotto-Gonzalez, Marco Antônio Fumagalli, Cid André Fidelis de Paula Gomes

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neck Pain, Functional Dyspepsia
    Keywords
    Neck pain, visceral manipulation, functional dyspepsia, electromyography, pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized, double-blinded, sham-controlled, study
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Visceral manipulation Group (VMG)
    Arm Type
    Experimental
    Arm Description
    The VMG wil be treated with visceral manipulation to the stomach and liver
    Arm Title
    Control group (CG)
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Visceral manipulation
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control group (CG)
    Intervention Description
    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 Measure Information:
    Title
    Pain intensity assessed with Numerical Rating Scale
    Description
    Numerical rating scale (NRS) (11 point; 0: no pain, 10: the worst possible pain imaginable) translated and cross-culturally adapted for the Brazilian population
    Time Frame
    12 months
    Title
    Pain area documented on a body chart
    Description
    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).
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Electromyography
    Description
    The sEMG signal of the upper trapezius muscle will be recorded on the side with the greatest self-reported pain.
    Time Frame
    12 months
    Title
    Cervical range of motion
    Description
    A flexometer (Sami ®) will be used to verify cervical range of motion (ROM) of the flexion/extension, right and left lateral flexion and rotation.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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).

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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.
    Citations:
    PubMed Identifier
    17369782
    Citation
    Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.
    Results Reference
    background
    Citation
    Barral JP, Mercier P. Visceral Manipulation. Eastland Press; 2005.
    Results Reference
    result

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

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