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

U

University of Nove de Julho

Status

Completed

Conditions

Functional Dyspepsia
Neck Pain

Treatments

Other: Control group (CG)
Other: Visceral manipulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03043625
VM-2016

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Visceral manipulation Group (VMG)
Experimental group
Description:
The VMG wil be treated with visceral manipulation to the stomach and liver
Treatment:
Other: Visceral manipulation
Control group (CG)
Placebo Comparator group
Description:
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.
Treatment:
Other: Control group (CG)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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