Evaluation of the Immediate Effect of Acupuncture on the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain.

Nonspecific Neck Pain Clinical Trial

Official title:

Evaluation of the Immediate Effect of Acupuncture on Pain, Cervical Range of Motion and Electromyographic Activity of the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain: Randomized, Single-blinded, Sham-controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984021
• Other study ID #: 483712
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 7, 2013
• Last updated: May 29, 2015
• Start date: December 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The aim of the proposed study is to evaluate the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain.Twelve patients with nonspecific neck pain and 12 healthy subjects will be enrolled in a randomized, single-blind, crossover study. Each patient will receive two forms of treatment in random order: a single session of traditional acupuncture and sham acupuncture. To eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions. Surface electromyography will be used to determine motor control in the upper trapezius muscle before and after treatment. The outcome measures in the group with neck pain will be a numerical pain rating scale (range: 0 [no pain] to 10 [maximum pain]), documentation of the pain area on a body chart and cervical range of motion. Linear regression analysis will be applied for each individual to investigate associations between the sEMG variables and force (excluding the sixth step). The slopes of the regression lines will be used to measure the sensitivity of the sEMG variables regarding changes in force. The Shapiro-Wilk test will be used to test the normality of the data distribution regarding RMS and MDF values in the third and sixth step of the step contraction. Paired samples (Student's t-test or Wilcoxon test) will be used to test differences between third and sixth contraction step. A mixed linear model will be used to analyze and compare the sEMG data during sustained contraction (five steps) between pre-acupuncture (EMG-1) and post-acupuncture (EMG-2) evaluations. These comparisons will demonstrate whether acupoints TE-5 and LI-11 affect the activity of the upper trapezius muscle, as hypothesized. The pain (NRS, PPT and area) and cervical ROM data collected during the four evaluations will also be compared using a mixed linear model. The Statistical Package for Social Sciences (SPSS, version 19.0 for Windows) will be employed for the statistical analysis, with the level of significance set to 5% (p < 0.05).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 18 to 40 years

• male and female volunteers

Exclusion Criteria:

• history of neurological disorders

• neck surgery

• chronic neck pain resulting from a traumatic incident

• chronic musculoskeletal condition

• medical diagnosis of fibromyalgia; systemic disease

• connective tissue disorder

• non-tolerance of needles; current pregnancy

• having undergone physical therapy use of analgesic, muscle relaxant.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain
• Nonspecific Neck Pain

Intervention

Device:
• Acupuncture

• Sham acupuncture

Locations

Country	Name	City	State
Brazil	University of Nove de Julho	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	electromyographic activity	The EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment.	1 Year	No
Secondary	cervical range of motion	A cervical range of motion instrument will be used to determine cervical spine movements. This instrument is composed of two gravity goniometers and a compass goniometer and has demonstrated to be a reliable tool with adequate validity. The device will be placed on the top of the head and the patient will be instructed to move the head as far as possible without pain in a standard fashion: right rotation, left rotation, flexion, extension, right lateral flexion and left lateral flexion. Three trials will be conducted in randomized order for each direction of movement and mean values will be recorded for analysis.	1 Year	No

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