Back to resultsTreatment of Neck Pain With Transcranial Direct Current Stimulation
Primary Purpose
Cervical Syndrome
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physiotherapy treatment with physium device.
Conventional physiotherapy treatment.
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Syndrome focused on measuring Neck Pain, Physical Therapy Modalities, Manual Therapy, massage, Transcranial Direct Current Stimulation, Transcutaneous electrical nerve stimulation
Eligibility Criteria
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.
Sites / Locations
- Policlínica Santa María
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
EXPERIMENTAL GROUP
CONTROL GROUP
Arm Description
The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.
The intervention for this group consisted of 10 sessions with Transcutaneous Electrical Nerve Stimulation (TENS) for a month.
Outcomes
Primary Outcome Measures
The intensity of cervical pain
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 Outcome Measures
The intensity of cervical pain
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.
The intensity of cervical pain
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.
Active cervical range of motion
Measured by goniometer type crom
Pressure pain thresholds in cervical trigger points
Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline,
The multidimensional health related quality of life.
Questionnaire SF 12.
Neck Disability Index (NDI).
Questionnaire Neck Disability Index (NDI).
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index
The study of anxiety, depression and stress
Scale 21 (DASS-21)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04729270
Brief Title
Treatment of Neck Pain With Transcranial Direct Current Stimulation
Official Title
Treatment of Neck Pain With Transcranial Direct Current Stimulation: A Single Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
June 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cadiz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Syndrome
Keywords
Neck Pain, Physical Therapy Modalities, Manual Therapy, massage, Transcranial Direct Current Stimulation, Transcutaneous electrical nerve stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.
Masking
Investigator
Masking Description
Blind researcher
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EXPERIMENTAL GROUP
Arm Type
Experimental
Arm Description
The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.
Arm Title
CONTROL GROUP
Arm Type
Experimental
Arm Description
The intervention for this group consisted of 10 sessions with Transcutaneous Electrical Nerve Stimulation (TENS) for a month.
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy treatment with physium device.
Intervention Description
The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.
Intervention Type
Procedure
Intervention Name(s)
Conventional physiotherapy treatment.
Intervention Description
The intervention for this group consisted of 10 sessions with Electrical Nerve Stimulation (TENS) for a month.
Primary Outcome Measure Information:
Title
The intensity of cervical pain
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
The intensity of cervical pain
Description
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.
Time Frame
Four weeks
Title
The intensity of cervical pain
Description
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.
Time Frame
Twelve weeks
Title
Active cervical range of motion
Description
Measured by goniometer type crom
Time Frame
Baseline,four weeks and Twelve weeks.
Title
Pressure pain thresholds in cervical trigger points
Description
Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline,
Time Frame
Baseline,four weeks and Twelve weeks.
Title
The multidimensional health related quality of life.
Description
Questionnaire SF 12.
Time Frame
Baseline,four weeks and Twelve weeks.
Title
Neck Disability Index (NDI).
Description
Questionnaire Neck Disability Index (NDI).
Time Frame
Baseline,four weeks and Twelve weeks.
Title
The Pittsburgh Sleep Quality Index
Description
The Pittsburgh Sleep Quality Index
Time Frame
Baseline,four weeks and Twelve weeks.
Title
The study of anxiety, depression and stress
Description
Scale 21 (DASS-21)
Time Frame
Baseline,four weeks and Twelve weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
manuel Rodríguez Huguet, Physiotherapy
Organizational Affiliation
University of Cádiz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlínica Santa María
City
Cadiz
State/Province
Cádiz
ZIP/Postal Code
11007
Country
Spain
12. IPD Sharing Statement
Citations:
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Treatment of Neck Pain With Transcranial Direct Current Stimulation
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