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

Primary Purpose

Nonspecific Neck Pain

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Acupuncture
Sham acupuncture
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonspecific Neck Pain focused on measuring Physical Therapy Modalities, Neck pain, Acupuncture

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Nove de Julho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

traditional acupuncture (tACP)

sham acupuncture (sACP)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 7, 2013
Last Updated
May 29, 2015
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT01984021
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonspecific Neck Pain
Keywords
Physical Therapy Modalities, Neck pain, Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
traditional acupuncture (tACP)
Arm Type
Experimental
Arm Description
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).
Arm Title
sham acupuncture (sACP)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Type
Device
Intervention Name(s)
Sham acupuncture
Primary Outcome Measure Information:
Title
electromyographic activity
Description
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.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
cervical range of motion
Description
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.
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Nove de Julho
City
Sao Paulo
ZIP/Postal Code
01415000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25872667
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.
Results Reference
derived
Links:
URL
http://www.uninove.br
Description
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Evaluation of the Immediate Effect of Acupuncture on the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain.

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