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Completed

NCT Number: NCT04729270

Treatment of Neck Pain With Transcranial Direct Current Stimulation

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).

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Key information

Conditions

Cervical Syndrome Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlínica Santa María

Cadiz, Cádiz, 11007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Physiotherapy treatment with physium device.

Procedure

The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.

Conventional physiotherapy treatment.

Procedure

The intervention for this group consisted of 10 sessions with Electrical Nerve Stimulation (TENS) for a month.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Active cervical range of motion

    Time frame: Baseline,four weeks and Twelve weeks.

    Measured by goniometer type crom

  4. 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,

  5. Neck Disability Index (NDI).

    Time frame: Baseline,four weeks and Twelve weeks.

    Questionnaire Neck Disability Index (NDI).

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2021
Registry last updated
Apr 17, 2024

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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