Clinical trial NCT03043625: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Functional Dyspepsia
Keywords: Neck pain
visceral manipulation
functional dyspepsia
electromyography
pain
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Andréia Cristina de Oliveira Silva
name: Claudia Santos Oliveira
name: Daniela Aparecida Biasotto-Gonzalez
name: Marco Antônio Fumagalli
name: Cid André Fidelis de Paula Gomes
First posted: 2017-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blinded, sham-controlled, study
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Pain intensity assessed with Numerical Rating Scale
timeFrame: 12 months
measure: Pain area documented on a body chart
timeFrame: 12 months
Secondary outcomes:
measure: Electromyography
timeFrame: 12 months
measure: Cervical range of motion
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.
citation: Barral JP, Mercier P. Visceral Manipulation. Eastland Press; 2005.