The Effects of tDAS Combined With Stabilization Exercises in Individuals With Chronic Neck Pain

NCT06193564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-01-05

No results posted yet for this study

Summary

The aim of study was to investigate the effect of cervical stabilization exercises (CSE) combined with tDCS on functional status, cognitive functions and sleep quality in individuals with chronic neck pain. A total of 29 individuals with chronic neck pain (33.06±14.81 age) were included in the study. Combined CSE with tDCS (2 mA/20 min) was applied to the experimental group (n=10); only CSE was applied to the control group (n=10); placebo tDCS (0 mA/20 min) and CSE were applied to the sham group (n=9). Before and after the 8-week intervention comprising a total of 16 sessions, the following assessments were carried out: Visual Analog Scale (VAS), Neck Bournemouth Questionnaire (NBQ), Cervical Muscle Endurance Tests, The Profile Fitness Mapping Neck Questionnaire (ProFitMap-neck), Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT) and Pittsburgh Sleep Quality Index (PSQI).

Conditions

  • Neck Pain

Interventions

OTHER

Transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation (tDCS) tDCS was administered using electrodes made of metal or conductive rubber, an electrode sponge, and an electrolyte-based contact medium applied to the sponge (6 ml of water for a 35 cm2 sponge). 'Chatanooga Ionto Iontophoresis Dual Channel System (USA)' was used in the study as a constant current stimulator for tDCS. The constant current stimulator was used to deliver the direct current in a constant manner by monitoring the resistance in the continuous system. Two electrodes were placed at 5 cm × 7 cm; 35 cm2; an anode was placed in the primary motor cortex (M1), while a cathode was placed in the contralateral supraorbital space (FP1 on the left and FP2 on the right, according to the EEG 10/20 system) A constant current of 2 mA was applied to the experimental group for 20 minutes.

OTHER

Cervical Stabilization Exercises

Before initiating the stabilization exercises, individuals included in the study were instructed on correct postural alignment. Cervical chin tuck movement was taught during the exercise along with postural alignment and craniocervical flexion movement was requested. After teaching craniocervical flexion exercises in all positions (supine, lying on the side, prone, crawling, sitting, and standing), participants were instructed to perform the movement slowly. The purpose of this phase was to establish the relationship between vision and motor learning using the Pressure Biofeedback Stabilizer device. The device was positioned on the neck area and inflated to 20 mmHg. The pressure level gradually increased in 2-mmHg increments from 20 to 30 mmHg. For each pressure value (22, 24, 26, 28, 30 mmHg), participants were asked to maintain craniocervical flexion for 10 seconds, and this exercise was repeated ten times.

OTHER

Sham-Transcranial Direct Current Stimulation (tDCS)

tDCS was administered using electrodes made of metal or conductive rubber, an electrode sponge, and an electrolyte-based contact medium applied to the sponge (6 ml of water for a 35 cm2 sponge). 'Chatanooga Ionto Iontophoresis Dual Channel System (USA)' was used in the study as a constant current stimulator for tDCS. The constant current stimulator was used to deliver the direct current in a constant manner by monitoring the resistance in the continuous system. Two electrodes were placed at 5 cm × 7 cm; 35 cm2; an anode was placed in the primary motor cortex (M1), while a cathode was placed in the contralateral supraorbital space (FP1 on the left and FP2 on the right, according to the EEG 10/20 system) (Figure 2). As shown in the figure, a constant current of 2 mA was applied to the experimental group for 20 minutes. For the sham group, electrodes were placed in the same areas and a current of 0 mA was applied.

Sponsors & Collaborators

  • Hacettepe University

    lead OTHER

Principal Investigators

  • Tuğba DERE · Yozgat Bozok University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-11-01
Completion
2023-12-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06193564 on ClinicalTrials.gov