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Completed

NCT Number: NCT03401905

Effects of Low Versus High Frequency Percutaneous Electrical Nerve Stimulation on 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.

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Key information

Conditions

Neck Pain Chronic Pain Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndrome Myofascial Pain Syndromes Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CSEU La Salle

Madrid, 28023, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low frequency

Procedure

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

High frequency

Procedure

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

Primary outcomes

  1. 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".

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Centro Universitario La Salle

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 17, 2018
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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