Treatment of Neck Pain With Transcranial Direct Current Stimulation

April 15, 2024 updated by: Manuel Rodriguez Huguet, University of Cadiz

Treatment of Neck Pain With Transcranial Direct Current Stimulation: A Single Blind Randomized Controlled Trial

This study aim to investigate the effects of Transcranial Direct Current Stimulation for improving pressure pain thresholds (PPTs), range of motion,Neck Disability Index, the multidimensional health related quality of life (SF-12) and the multidimensional health related quality of life and pain in patients with mechanical neck pain (NP).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fifty-four participants with NP will randomly allocated to either an Transcranial Direct Current Stimulation (ten sessions) or transcutaneous electric nerve stimulation (TENS) (ten sessions) during two weeks. . Visual Analogue Scale (VAS), Neck Disability Index ( NDI), range of motion and (CROM), Questionnaire SF-12 and PPTs in sub-occipital and upper trapezius muscles were measured at baseline, at the end of treatment and at 1 month follow-up. T-tests and a repeated-measures multivariate analysis of variance (RM-MANOVA) were used for VAS, CROM and PPTs, respectively.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cádiz
      • Cadiz, Cádiz, Spain, 11007
        • Policlínica Santa María

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of both sexes,
  • Aged between 18 and 60 years, in an
  • Active state of pain and diagnosed with a month of evolution.

Exclusion Criteria:

- Patients who are pregnant, have pacemaker and those Surgically operated cervical spine - Patients who have been treated with Transcranial Direct Current Stimulation a month earlier.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EXPERIMENTAL GROUP
The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.
Procedure: Physiotherapy treatment with physium device.
The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.
Experimental: CONTROL GROUP
The intervention for this group consisted of 10 sessions with Transcutaneous Electrical Nerve Stimulation (TENS) for a month.
Procedure: Conventional physiotherapy treatment.
The intervention for this group consisted of 10 sessions with Electrical Nerve Stimulation (TENS) for a month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensity of cervical pain
Time Frame: Baseline
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensity of cervical pain
Time Frame: Four weeks
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.
Four weeks
The intensity of cervical pain
Time Frame: Twelve weeks
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.
Twelve weeks
Active cervical range of motion
Time Frame: Baseline,four weeks and Twelve weeks.
Measured by goniometer type crom
Baseline,four weeks and Twelve weeks.
Pressure pain thresholds in cervical trigger points
Time Frame: Baseline,four weeks and Twelve weeks.
Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline,
Baseline,four weeks and Twelve weeks.
Neck Disability Index (NDI).
Time Frame: Baseline,four weeks and Twelve weeks.
Questionnaire Neck Disability Index (NDI).
Baseline,four weeks and Twelve weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cadiz

Investigators

  • Principal Investigator: manuel Rodríguez Huguet, Physiotherapy, University of Cadiz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

November 20, 2023

Study Registration Dates

First Submitted

January 24, 2021

First Submitted That Met QC Criteria

January 27, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tDCS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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