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

NCT06193564 | Completed DMC

• 2 other identifiers: TDERE1919B012105580
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Transcranial direct current stimulation; neck pain; endurance; functional status; cognitive function

Outcome Measures

Primary Outcomes (7)

• Assessment of Pain Severity

  In order to evaluate the pain intensity of individuals with chronic neck pain, 10-cm Visual Analogue Scale (VAS) developed by Price et al. The 10-cm VAS is used to mark pain on a horizontal line where the first notch is 0, indicating no pain, and the last notch is 10, indicating the most severe pain. Participants marked their neck pain levels on the line, and the measurements were recorded in centimeters using a ruler.

  January 2023 to November 2023 (10 months)

• Assessment of Pain Severity

  The NBQ was used to inquire about participants' neck pain severity as well as symptoms such as the impact of neck pain on their daily activities and social life, levels of anxiety and depression, kinesiophobia, and methods of coping with pain in the previous week. The Turkish version of the NBQ, validated for reliability by Telci et al, consists of 7 questions, each scored on a scale of 0 to 10. A possible total score of 70 indicates more severe.

  January 2023 to November 2023 (10 months)

• Assessment of Muscular Endurance

  To evaluate the cervical deep flexor muscular endurance test, participants took a hook-lying posture on a therapy table, maintaining a neutral neck position with the head and neck straightly aligned. With the assistance of a stabilizing device, a pressure sensor was situated under the neck with a stabilizer (Stabilizer Biofeedback). Participants were instructed to simulate a "yes" motion by gently nodding their heads, while avoiding movements that could activate the sternocleidomastoid muscle. The test involved a pressure range of 20-30 mmHg and required ten-second sustained pressure at each 2-mmHg increment without any breaks. The activation score was determined by measuring the pressure level at which the patient was able to perform and sustain 10 repetitions for a duration of 10 seconds, providing a measure of the strength of the deep cervical flexor muscles.

  January 2023 to November 2023 (10 months)

• Assessment of Functional Limitations and Symptoms

  The Profile Fitness Mapping neck questionnaire (ProFitMap-neck) was used to assess the functional limitations and symptoms associated with neck pain. The survey was graded on a scale of 0-100%, showing the highest score possible. This was the best result attainable through the assessment of the questionnaire. In addition to assessing neck pain, ProFitMap-neck considers stiffness, tension, and weakness that might occur in the neck and hands. This survey consists of two sub-indices. The first consists of 26 items that comprehensively assess the frequency and severity of symptoms, while the second comprises 18 items that assess functional limitations. Symptom frequency is rated on a scale of 1 to 6 points, where 1 indicates "not at all/rarely" and 6 corresponds to "often/always," as described in the Symptom Frequency Index. Symptom severity was rated on a scale of 7 to 12, with 7 being "not at all" and 12 being "almost unbearable/unbearable/very.

  January 2023 to November 2023 (10 months)

• Assessment of Cognitive Status

  Individuals' cognitive status was assessed using the Montreal Cognitive Assessment (MoCA). The MoCA is a concise measurement tool developed by Ziad Nasreddine et al and used to detect mild cognitive impairment. MoCA application takes approximately 10 minutes. The highest total score that can be obtained from the test is 30. Accordingly, a score of 21 points or above is considered normal.

  January 2023 to November 2023 (10 months)

• Assessment of Cognitive Status

  The Trail Making Test is a cognitive assessment tool that evaluates various cognitive functions such as visual-motor coordination, conceptual scanning, motor speed, planning, numerical knowledge, abstract thinking, and response tendency based on physical attributes of stimuli, set shifting, concentration, and tolerance to interference. Scoring is based on time taken to complete the test (e.g. 35 seconds yielding a score of 35) with lower scores being better. Different norms are available that allow comparison with age-matched groups.

  January 2023 to November 2023 (10 months)

• Assessment of Sleep Quality

  The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality in individuals with chronic neck pain. The PSQI utilizes a standardized questionnaire to distinguish between good and poor sleepers. This comprises 19 self-rated questions and 5 questions answered by a bedmate/roommate. These 5 questions do not contribute to the scoring from a clinical perspective. The items of the PSQI use various response categories, including recording usual bedtime, usual wake time, number of hours actually slept, and number of minutes to fall asleep, as well as forced-choice Likert-type responses (0-3). The total scores of the components generate a single global score, ranging from 0 to 21.

  January 2023 to November 2023 (10 months)

Study Arms (3)

Combined CSE with tDCS

EXPERIMENTAL

Combined cervical stabilzation exercises with tDCS

Other: Transcranial Direct Current Stimulation; Other: Cervical Stabilization Exercises

control group

EXPERIMENTAL

Only cervical stabilzation exercises

Other: Cervical Stabilization Exercises

placebo tDCS and CSE

PLACEBO COMPARATOR

Placebo tDCS and cervical stabilzation exercises

Other: Cervical Stabilization Exercises; Other: Sham-Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation OTHER

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.

Combined CSE with tDCS

Cervical Stabilization Exercises OTHER

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.

Combined CSE with tDCS; control group; placebo tDCS and CSE

Sham-Transcranial Direct Current Stimulation (tDCS) OTHER

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.

placebo tDCS and CSE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals between 18 and 65 years of age who had suffered from neck pain for at least 3 months
• The rest pain score of 3-7 on the \"Visual Analog Scale\" (Javdaneh et al, 2021)

You may not qualify if:

• Neurological or psychiatric disorders,
• including acute/chronic depression, history of head trauma resulting in loss of consciousness
• epilepsy
• history of neurosurgical intervention
• intracranial hypertension
• implanted devices
• history of migraine
• history of chronic/severe headache
• skin conditions (psoriasis, etc.), uncontrollable diseases (endocrinologic, cardiovascular, pulmonary, hematologic, hepatic, renal)
• presence of systemic inflammatory disease or malignancy

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (3)

Erciyes University

Talas, Kayseri, 38000, Turkey (Türkiye)

Location

Erciyes University

Kayseri, 38000, Turkey (Türkiye)

Location

Erciyes University

Kayseri, Turkey (Türkiye)

Location

Related Publications (3)

• Iqbal ZA, Alghadir AH, Anwer S. Efficacy of Deep Cervical Flexor Muscle Training on Neck Pain, Functional Disability, and Muscle Endurance in School Teachers: A Clinical Trial. Biomed Res Int. 2021 Jan 13;2021:7190808. doi: 10.1155/2021/7190808. eCollection 2021.

  PMID: 33521131 RESULT

• Jull GA, O'Leary SP, Falla DL. Clinical assessment of the deep cervical flexor muscles: the craniocervical flexion test. J Manipulative Physiol Ther. 2008 Sep;31(7):525-33. doi: 10.1016/j.jmpt.2008.08.003.

  PMID: 18804003 RESULT

• Juan W, Rui L, Wei-Wen Z. Chronic neck pain and depression: the mediating role of sleep quality and exercise. Psychol Health Med. 2020 Sep;25(8):1029-1035. doi: 10.1080/13548506.2020.1724308. Epub 2020 Feb 4.

  PMID: 32013565 RESULT

MeSH Terms

Conditions

Neck Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Tuğba DERE

  Yozgat Bozok University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, Master Student (PT, MSc)

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: January 5, 2024
• Study Start: January 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)