NCT03401905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

February 9, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

December 21, 2017

Last Update Submit

May 3, 2018

Conditions

Neck PainChronic PainMyofascial Pain Syndrome

Keywords

Percutaneous electrical nerve stimulationMyofascial trigger point

Outcome Measures

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".

    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 (3)

  • 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.

  • Neck disability index.

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

  • kinesiofobia

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

Study Arms (2)

Low frequency

EXPERIMENTAL

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

Procedure: Low frequency

High frequency

ACTIVE COMPARATOR

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

Procedure: High frequency

Interventions

Low frequencyPROCEDURE

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
Low frequency
High frequencyPROCEDURE

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
High frequency

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSEU La Salle

Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Neck PainChronic PainMyofascial Pain Syndromes

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Jose V León Hernández, PhD

    CSEU La Salle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Randomized list that was only known by the therapist. Subjects do not know about the treatment they were receiving.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blind randomized control trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator.

Study Record Dates

First Submitted

December 21, 2017

First Posted

January 17, 2018

Study Start

February 9, 2018

Primary Completion

April 9, 2018

Study Completion

April 9, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

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

Locations

ES(1)