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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401905
• Other study ID #: CSEULS-PI-115/2016
• Status: Completed
• Phase: N/A
• Start date: February 9, 2018
• Est. completion date: April 9, 2018

Study information

• Verified date: May 2018
• Source: Centro Universitario La Salle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 9, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Neck Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	CSEU La Salle	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitario La Salle

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	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	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.	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	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.	Pre treatment at the beginning of the study and one month later, on the last of the follow up period.
Secondary	kinesiofobia	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.