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

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

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.

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia; Neck Pain
• Intervention / Treatment: Other: Visceral manipulation; Other: Control group (CG)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyography	The sEMG signal of the upper trapezius muscle will be recorded on the side with the greatest self-reported pain.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Collaborators: Daniela Aparecida Biasotto-Gonzalez; Marco Antônio Fumagalli; Cid André Fidelis de Paula Gomes; Andréia Cristina de Oliveira Silva; Claudia Santos Oliveira

Publications and helpful links

General Publications

• Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.
• Barral JP, Mercier P. Visceral Manipulation. Eastland Press; 2005.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): January 30, 2017
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (ESTIMATE): February 6, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: pain; electromyography; functional dyspepsia; Neck pain; visceral manipulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Dyspepsia; Neck Pain
• Other Study ID Numbers: VM-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No