Clinical trial NCT01984021: Evaluation of the Immediate Effect of Acupuncture on the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nonspecific Neck Pain
Keywords: Physical Therapy Modalities
Neck pain
Acupuncture
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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.

Primary outcomes:
measure: electromyographic activity
timeFrame: 1 Year
Secondary outcomes:
measure: cervical range of motion
timeFrame: 1 Year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Nove de Julho
Study officials:
References:
citation: Calamita SA, Biasotto-Gonzalez DA, De Melo NC, dos Santos DM, de Lassa R, de Mendonca FS, Oliveira CS, Amorim CF, Gonzalez TO, Fumagalli MA, de Gomes CA, Politti F. 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: study protocol for a randomized controlled trial. Trials. 2015 Mar 19;16:100. doi: 10.1186/s13063-015-0623-3.