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CompletedNCT03401905Updated May 9, 2018

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

An interventional study of Low frequency and High frequency in Neck Pain, Chronic Pain and Myofascial Pain Syndrome, sponsored by Centro Universitario La Salle. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-09.

Sponsored by Centro Universitario La Salle · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Neck Pain
  • Chronic Pain
  • Myofascial Pain Syndrome

Keywords

  • Percutaneous electrical nerve stimulation
  • Myofascial trigger point
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Upper limb radiculopathy.
  • Recent whiplash.
  • Cervicogenic dizziness.
  • Migraine.
  • Previous cervical surgery.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Low frequency

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

    Procedure: Low frequency

  • 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

Interventions

  • ProcedureLow 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.

    Also known as: Low frequency group

  • ProcedureHigh 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.

    Also known as: High frequency group

05

What researchers measure

Primary outcomes

  1. 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".

    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 outcomes

  1. 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.

    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.

  2. 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.

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

  3. kinesiofobia

    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.

06

Study locations

1 site
  • CSEU La Salle
    Madrid, 28023, Spain
07

References and documents

Individual participant data

Plan to share: No — Data collected will be used only for research objective. Once the trial have finished, data will be destroyed.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03401905
Lead sponsor
Centro Universitario La Salle
Responsible party
Jose Vicente Leon Hernandez (Principal investigator., Centro Universitario La Salle) — Principal investigator
First posted
Jan 17, 2018
Start date
Feb 9, 2018
Primary completion
Apr 9, 2018
Completion
Apr 9, 2018
Last update
May 9, 2018

Study contacts

Jose V León Hernández, PhD
principal investigator · CSEU La Salle

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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