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

NCT03043625 | Completed DMC

• 1 other identifier: VM-2016
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neck Pain; Functional Dyspepsia

Keywords

Neck pain; visceral manipulation; functional dyspepsia; electromyography; pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Electromyography

  12 months

• Cervical range of motion

  12 months

Study Arms (2)

Visceral manipulation Group (VMG)

EXPERIMENTAL

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

Other: Visceral manipulation

Control group (CG)

PLACEBO COMPARATOR

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)

Interventions

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.

Visceral manipulation Group (VMG)

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.

Control group (CG)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Related Publications (2)

• Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.

  PMID: 17369782 BACKGROUND

• Barral JP, Mercier P. Visceral Manipulation. Eastland Press; 2005.

  RESULT

MeSH Terms

Conditions

Neck Pain; Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized, double-blinded, sham-controlled, study

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 6, 2017
• Study Start: October 1, 2016
• Primary Completion: January 30, 2017
• Study Completion: February 1, 2017
• Last Updated: February 6, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share