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

Not Applicable

Completed

• Conditions: Myofascial Pain Syndrome; Chronic Pain; Neck Pain
• Interventions: Procedure: Low frequency; Procedure: High frequency

• Registration Number: NCT03401905
• Lead Sponsor: Centro Universitario La Salle

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Study Start: 2018-02-09
• Primary Completion: 2018-04-09
• Study Completion: 2018-04-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low frequency	Low frequency	Percutaneous electrical nerve stimulation with frequency of 2 Hz and 120 microseconds of pulse width will be applied.
High frequency	High frequency	Percutaneous electrical nerve stimulation with frequency of 120 Hz and 200 microseconds of pulse width will be applied.

Primary Outcome Measures

Name	Time	Method
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.	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

Name	Time	Method
Neck disability index.	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.
kinesiofobia	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.
Pressure pain threshold	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.

Trial Locations

Locations (1)

CSEU La Salle; 🇪🇸 Madrid, Spain