Neck Pain Clinical Trial
— tDASOfficial title:
Investigation of the Effects of Transcranial Direct Current Stimulation Combined With Stabilization Exercises on Functional Status, Cognitive Functions, and Sleep Quality in Individuals With Chronic Neck Pain: A Randomized Controlled Study
Verified date | December 2023 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 29 |
Est. completion date | December 1, 2023 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Erciyes University | Kayseri | |
Turkey | Erciyes University | Kayseri | |
Turkey | Erciyes University | Talas | Kayseri |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
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. eCollecti — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) |
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