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

Not Applicable

Completed

• Conditions: Neck Pain; Functional Dyspepsia
• Interventions: Other: Visceral manipulation; Other: Control group (CG)

• Registration Number: NCT03043625
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Primary Completion: 2017-01-30
• Status Verified: 2017-02
• Study Completion: 2017-02-01
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-03
• Last Update Submitted: 2017-02-03
• Study First Posted: 2017-02-06
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Visceral manipulation Group (VMG)	Visceral manipulation	The VMG wil be treated with visceral manipulation to the stomach and liver
Control group (CG)	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

Name	Time	Method
Pain intensity assessed with Numerical Rating Scale	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
Pain area documented on a body chart	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

Name	Time	Method
Electromyography	12 months	The sEMG signal of the upper trapezius muscle will be recorded on the side with the greatest self-reported pain.
Cervical range of motion	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.