Neck Pain Clinical Trial
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
Verified date | February 2017 |
Source | University of Nove de Julho |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
n/a |
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 |
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
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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