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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03043625
Other study ID # VM-2016
Secondary ID
Status Completed
Phase N/A
First received February 1, 2017
Last updated February 3, 2017
Start date October 1, 2016
Est. completion date February 1, 2017

Study information

Verified date February 2017
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 1, 2017
Est. primary completion date January 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (6)

Lead Sponsor Collaborator
University of Nove de Julho Andréia Cristina de Oliveira Silva, Cid André Fidelis de Paula Gomes, Claudia Santos Oliveira, Daniela Aparecida Biasotto-Gonzalez, Marco Antônio Fumagalli

References & Publications (2)

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

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Electromyography The sEMG signal of the upper trapezius muscle will be recorded on the side with the greatest self-reported pain. 12 months
Secondary 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
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