Effects of Low Versus High Frequency Percutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients.

May 3, 2018 updated by: Jose Vicente Leon Hernandez, Centro Universitario La Salle

Comparison and Effects of Low and High Frequency Percutaneous Electrical Nerve Stimulation on Myofascial Chronic Neck Pain Patients.

Comparison between high and low frequency percutaneous electrical nerve stimulation as treatment of myofascial chronic neck pain. The main hypothesis is that low frequency treatment will have more hypoalgesic effects than high frequency, and low frequency effects will last longer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28023
        • CSEU La Salle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Neck pain of more than 6 months of evolution.
  • Pain level of more than 30 millimeter on the VAS scale.
  • Active myofascial frigger points on upper trapezius muscle.

Exclusion Criteria:

  • Upper limb radiculopathy.
  • Recent whiplash.
  • Cervicogenic dizziness.
  • Migraine.
  • Previous cervical surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low frequency
Percutaneous electrical nerve stimulation with frequency of 2 Hz and 120 microseconds of pulse width will be applied.
Procedure: Low frequency
A dry needling on trapezius muscle is performed, until two local twitch responses are obtained. The needle is kept inside the trigger point, as it will be the negative electrode, and an adhesive electrode will be added as the positive one. After that, a low frequency TENS is applied, at 2 Hz frequency and 120 microseconds of pulse width.
Other Names:
  • Low frequency group
Active Comparator: High frequency
Percutaneous electrical nerve stimulation with frequency of 120 Hz and 200 microseconds of pulse width will be applied.
Procedure: High frequency
A dry needling on trapezius muscle is performed, until two local twitch responses are obtained. The needle is kept inside the trigger point, as it will be the negative electrode, and an adhesive electrode will be added as the positive one. After that, a high frequency TENS is applied, at 12o Hz frequency and 200 microseconds of pulse width.
Other Names:
  • High frequency group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Changes on pain will be assessed during one month follow up. Baseline will be measured on the first day and one month later pain score will be reassessed.
Subjective feeling expressed by subjects in the area of discomfort. It will be measured by a Visual Analogue Scale, meaning a score of 0 points/centimiters "no pain" and a score of 10 points/centimiters "unbearable pain".
Changes on pain will be assessed during one month follow up. Baseline will be measured on the first day and one month later pain score will be reassessed.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold
Time Frame: Changes on pain will be assessed during one month follow up. Baseline will be measured on the first day and one month later pain score will be reassessed.
Minimal amount of pressure that induces pain. An algometer will be used to measure pressure pain threshold. Units will be kilograms per square centimeter. The higher the score is, the less sensitive the area will be.
Changes on pain will be assessed during one month follow up. Baseline will be measured on the first day and one month later pain score will be reassessed.
Neck disability index.
Time Frame: Pre treatment at the beginning of the study and one month later, on the last of the follow up period.
Ten items questionnaire designed to asses the level of pain and self-assessment of cervical disability. The NDI (Spanish version) is composed of 10 questions related to daily functional activities. NDI presents an acceptable reliability with an intraclass correlation coeffcient (ICC) ranging from 0.50 to 0.98. It has been proposed that the clinically important difference required for NDI is seven points.
Pre treatment at the beginning of the study and one month later, on the last of the follow up period.
kinesiofobia
Time Frame: Pre treatment at the beginning of the study and one month later, on the last of the follow up period.
Eleven items questionnaire designed to asses pain-related fear. TSK-11, Spanish version.
Pre treatment at the beginning of the study and one month later, on the last of the follow up period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Universitario La Salle

Investigators

  • Principal Investigator: Jose V León Hernández, PhD, CSEU La Salle

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2018

Primary Completion (Actual)

April 9, 2018

Study Completion (Actual)

April 9, 2018

Study Registration Dates

First Submitted

December 21, 2017

First Submitted That Met QC Criteria

January 9, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSEULS-PI-115/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data collected will be used only for research objective. Once the trial have finished, data will be destroyed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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