Treatment of Neck Pain With Transcranial Direct Current Stimulation

Not Applicable

Completed

• Conditions: Cervical Syndrome
• Interventions: Procedure: Conventional physiotherapy treatment.; Procedure: Physiotherapy treatment with physium device.

• Registration Number: NCT04729270
• Lead Sponsor: University of Cadiz

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.

Study Timeline

• Study First Submitted: 2021-01-24
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-01-28
• Study Start: 2023-02-06
• Primary Completion: 2023-03-15
• Study Completion: 2023-11-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The intensity of cervical pain	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 Outcome Measures

Name	Time	Method
The intensity of cervical pain	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.
Active cervical range of motion	Baseline,four weeks and Twelve weeks.	Measured by goniometer type crom
Pressure pain thresholds in cervical trigger points	Baseline,four weeks and Twelve weeks.	Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline,
Neck Disability Index (NDI).	Baseline,four weeks and Twelve weeks.	Questionnaire Neck Disability Index (NDI).

Trial Locations

Locations (1)

Policlínica Santa María; 🇪🇸 Cadiz, Cádiz, Spain