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

Primary Purpose

Neck Pain, Chronic Pain, Myofascial Pain Syndrome

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Low frequency

High frequency

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Percutaneous electrical nerve stimulation, Myofascial trigger point

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CSEU La Salle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low frequency

High frequency

Arm Description

Percutaneous electrical nerve stimulation with frequency of 2 Hz and 120 microseconds of pulse width will be applied.

Percutaneous electrical nerve stimulation with frequency of 120 Hz and 200 microseconds of pulse width will be applied.

Outcomes

Primary Outcome Measures

Pain

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".

Secondary Outcome Measures

Pressure pain threshold

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.

Neck disability index.

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.

kinesiofobia

Eleven items questionnaire designed to asses pain-related fear. TSK-11, Spanish version.

Full Information

NCT ID

NCT03401905

First Posted

December 21, 2017

Last Updated

May 3, 2018

Sponsor

Centro Universitario La Salle

1. Study Identification

Unique Protocol Identification Number

NCT03401905

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

February 9, 2018 (Actual)

Primary Completion Date

April 9, 2018 (Actual)

Study Completion Date

April 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centro Universitario La Salle

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain, Chronic Pain, Myofascial Pain Syndrome

Keywords

Percutaneous electrical nerve stimulation, Myofascial trigger point

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Double blind randomized control trial.

Masking

ParticipantOutcomes Assessor

Masking Description

Randomized list that was only known by the therapist. Subjects do not know about the treatment they were receiving.

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low frequency

Arm Type

Experimental

Arm Description

Percutaneous electrical nerve stimulation with frequency of 2 Hz and 120 microseconds of pulse width will be applied.

Arm Title

High frequency

Arm Type

Active Comparator

Arm Description

Percutaneous electrical nerve stimulation with frequency of 120 Hz and 200 microseconds of pulse width will be applied.

Intervention Type

Procedure

Intervention Name(s)

Low frequency

Other Intervention Name(s)

Low frequency group

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

High frequency

Other Intervention Name(s)

High frequency group

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain

Description

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.

Secondary Outcome Measure Information:

Title

Pressure pain threshold

Description

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.

Title

Neck disability index.

Description

Time Frame

Pre treatment at the beginning of the study and one month later, on the last of the follow up period.

Title

kinesiofobia

Description

Eleven items questionnaire designed to asses pain-related fear. TSK-11, Spanish version.

Time Frame

Pre treatment at the beginning of the study and one month later, on the last of the follow up period.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose V León Hernández, PhD

Organizational Affiliation

CSEU La Salle

Official's Role

Principal Investigator

Facility Information:

Facility Name

CSEU La Salle

City

Madrid

ZIP/Postal Code

28023

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Learn more about this trial

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

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