NCT04148469

Brief Summary

The purpose of this estudy was to dertermine if the application of Transcutaneous Nerve Stimiulation (TENS) current have an hypoalgesic effect on pattientes suffering from miofascial neck pain, compared with a only dry needling treatment. Psicological varaibles were also mesured in order to determine how they change after each treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

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

Study Start

First participant enrolled

November 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2013

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

October 30, 2019

Last Update Submit

October 30, 2019

Conditions

Keywords

Miofascial pain syndrom.Trigger point.Dry needling.Transcotaneous Nerve Stimuilation.Hipoalgesia

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    Visual Analogue Scale (VAS) is a subjective evaluation. There are previous studies that demonstrate its reliability and its sensitivity, wich give validity to VAS messures. The messure is made using a two sides 10 centimeters scale. The patient´s face shows an increasing slope that allows the patient to mark his pain level. That mark has his equivalent number on the scale, so 0 is no pain and 10 is maximum pain. A differece of 2 points on the scale means the minimum clinically significant change.

    Patients will be reassed in four days.

Secondary Outcomes (2)

  • Active Cervical Range of Movement

    Patient will be reassed in four days.

  • Pressure Pain Threshold

    Patients will be reassed in four days.

Study Arms (3)

dry needling and TENS

EXPERIMENTAL

A dry needling treatment was performed on trapezius trigger point number 2, and just after thar, a TENS curretn was applied. Patients will be reassed on fourth day after treatment.

Procedure: Transcutaneous Nerve Stimulation.

Placebo

PLACEBO COMPARATOR

A placebo dry needling was performed on trapezius trigger point number 2. Patients will be reassed on fourth day after treatment.

Procedure: Placebo needling

dry needling

EXPERIMENTAL

A dry needling treatment was performed on trapezius trigger point number 2. Patients will be reassed on fourth day after treatment.

Procedure: Dry needling

Interventions

Dry needlingPROCEDURE

Dry needlin is a manual therapy technique used for miofascuial pain syndrom treatment. The patient will be supine, in a confortable position. The therapist localizes the trapezius trigger point number 2 and then performes the needling until 2 REL are obtenined. The patient will remain supine during 15 minutes.

dry needling

Transcutaneous Nerve Stimulation (TENS) is a current used for pain treatment. The needle will be used as the negative pole and a adhesive patch 2 centimeters lateral will be the positive pole. The frecuency selected will have 2 Hz with pulses of 120 microseconds. The currente will be applied for 15 minutes.

dry needling and TENS

No active technique is performed with the placebo needling. Patient will be supine and a placebo needle willb be performed. The patient will remain supine for 15 minutes.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Mechanical Neck pain of at least 6 months.
  • VAS 2 or greather.
  • Existance of miofascial trigger point in trapezius muscle assesed by an expert PT.

You may not qualify if:

  • Neck pain due secondary to ostheoporosis, metastasis, neoplasias, fractures, infections, cervical stenosis or infexious procces.
  • Headache secondary to medular compression presenting one o the following signs: abnormal sensitivity, hiperreflexia, clonus, spread weakness, cervical hernia.
  • Neck pain with radiculopathy.
  • Whiplash.
  • Vertebrobasilar syndrome.
  • Dizzyness.
  • Pregnancy.
  • Having received dry needling treatment before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Dry NeedlingTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesElectric Stimulation TherapyRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Jose Vicente León Hernández, PT

    Universitdad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 1, 2019

Study Start

November 1, 2012

Primary Completion

June 12, 2013

Study Completion

December 10, 2013

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations