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Completed

NCT Number: NCT03043625

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

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.

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Key information

Conditions

Neck Pain Functional Dyspepsia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Visceral manipulation

Other

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.

Control group (CG)

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • Andréia Cristina de Oliveira Silva
  • Cid André Fidelis de Paula Gomes
  • Claudia Santos Oliveira
  • Daniela Aparecida Biasotto-Gonzalez
  • Marco Antônio Fumagalli

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 6, 2017
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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