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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cid André Fidelis de Paula Gomes, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT01984021
First received: November 7, 2013
Last updated: March 29, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention Phase
Nonspecific Neck Pain
Device: Acupuncture
Device: Sham acupuncture
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Nove de Julho:

Primary Outcome Measures:
  • electromyographic activity [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • cervical range of motion [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: December 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: traditional acupuncture (tACP)
In the upper trapezius muscle with the greatest area pain and lowest PPT score will be chosen for acupuncture. Sterile acupuncture needles measuring 0.25 x 13 mm (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd.®) will be inserted in TE-5 (located on the dorsal face of the forearm between the radius and ulna 3 cm above the joint line of the wrist) and LI-11 (located at the outermost point of the skinfold of elbow flexion in the direction of the lateral epicondyle of the elbow).
Device: Acupuncture
Placebo Comparator: sham acupuncture (sACP)
The needles will be inserted 1 cm to the side of TE-5 (located on the dorsal face of the forearm between the radius and ulna 3 cm above the joint line of the wrist) and 1 cm to the side of LI-11 (in the direction of the styloid process of the radius).The acupuncture needles are positioned at different acupoints.
Device: Sham acupuncture

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01984021

Locations
Brazil
University of Nove de Julho
Sao Paulo, Brazil, 01415000
Sponsors and Collaborators
University of Nove de Julho
  More Information

Additional Information:
No publications provided

Responsible Party: Cid André Fidelis de Paula Gomes, MSc, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT01984021     History of Changes
Other Study ID Numbers: 483712
Study First Received: November 7, 2013
Last Updated: March 29, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Nove de Julho:
Physical Therapy Modalities
Neck pain
Acupuncture

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014