NCT06504004

Brief Summary

Background: The aim of this study was to investigate the relationship between cognitive function and pain, functional limitations, and cervical muscle endurance in individuals with chronic neck pain (CNP). Methods: The study included 29 individuals (28F, 1M) aged between 18 and 65 years, with non-specific neck pain lasting for at least 3 months, non-neurological symptoms, and no history of head, neck or upper extremity surgery in the last 6 months. Cognitive functions were assessed using the Montreal Cognitive Assessment (MOCA) and Trail Making Test (TMT), pain level using the Visual Analog Scale (VAS) and Bournemouth Neck Pain Questionnaire (BNPQ), functional limitations using the The Profile Fitness Mapping neck questionnaire (ProFitMap-neck) and muscle endurance using cervical flexor, extensor, and deep flexor muscle endurance tests.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 3, 2024

Last Update Submit

July 10, 2024

Conditions

Keywords

Neck paincognitive functionfunctional status

Outcome Measures

Primary Outcomes (7)

  • Pain-Visual Analogue Scale (VAS)

    The study evaluated the degree of neck pain experienced by individuals with chronic neck pain using two different methods: the 10 cm Visual Analogue Scale (VAS) developed by Price et al. Price et al. 1983). Participants were asked to indicate their level of neck pain on a 10 cm horizontal line, where 0 indicates no pain and 10 indicates unbearable pain, during rest, at night, and during activity

    Jun 2024

  • Pain-Bournemouth Neck Pain Questionnaire (BNPQ)

    BNPQ evaluates individuals with neck pain based on pain intensity, participation in family and social life, depression, anxiety, kinesiophobia, coping skills with pain in the last week, and other relevant factors. The questionnaire consists of 7 questions, and individuals are asked to score each question on a scale of 0 to 10. The total score ranges from 0 to 70, with higher scores indicating more severe neck pain. Telci et al. conducted a study to assess the validity and reliability of the questionnaire in the Turkish population.

    Jun 2024

  • Assessment of Cognitive Status-Montreal Cognitive Assessment (MoCA)

    The MoCA, a tool for detecting mild cognitive impairment, was developed by Nasreddine et al (Nasreddine et al. 2005). Its Turkish validity and reliability were established by Selekler et al. The total score ranges from 0 to 30, with a score of 26 and above indicating normal cognitive status.

    Jun 2024

  • Assessment of Cognitive Status-Trail Making Test (TMT)

    TMT is a cognitive assessment tool that evaluates various cognitive functions, including visual-motor coordination, conceptual scanning, motor speed, planning, numerical knowledge, abstract thinking, tendency to react based on the physical characteristics of the stimulus, set switching, concentration, and movement. The questionnaire is divided into two parts, Part A and Part B. Part A assesses psychomotor speed and attention, while Part B assesses executive functions such as set switching, visual scanning speed, and visual alertness. Turkish validity and reliability of the questionnaire was performed by Türkeş et al. (Türkeş et al. 2015).

    Jun 2024

  • Evaluation of Functional Status-Profit Neck Mapping Questionnaire (ProFitMap-Neck)

    The Profit Neck Mapping Questionnaire (ProFitMap-Neck) was implemented to assess the symptoms and functional limitations of individuals with chronic neck pain. The questionnaire consists of 26 items, including pain, tension, sensation, and balance, which are scored for frequency and severity of each symptom, resulting in two separate scores: symptom frequency score and symptom severity score. The functional limitation scale assesses the difficulty of performing activities such as lifting weights and wearing a t-shirt, resulting in a functional limitation score ranging from 0-100. An increase in the score indicates an improvement in functional status (Björklund et al. 2012).

    Jun 2024

  • Evaluation of Functional Status-Stabilizer biofeedback

    Stabilizer biofeedback was used to evaluate the endurance of the deep cervical flexor muscles. Patients in a supine position had the stabilizer placed on their cervical region and were instructed to slowly nod their head, simulating a 'yes' movement. The test ranged from 20 mmHg to 30 mmHg, with the pressure needing to be sustained for 10 seconds at every 2 mmHg increase without interruption. The activation score and performance index were determined by evaluating the patient's capacity to execute and sustain 10 repetitions over a 10-second interval at a particular pressure level.

    Jun 2024

  • Evaluation of Functional Status-Cervical Flexor Endurance Test

    the endurance of the cervical flexor muscles was assessed using the cervical flexor muscle endurance test. According to this test, the maximum time that an individual could lift and hold their head at a height of approximately 2.5 cm in a supine hooked position with their hands on their abdomen and chin retracted was recorded (Domenech et al. 2011).

    Jun 2024

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

It is worth noting that all individuals participating in the study provided written informed consent. The study involved individuals between the ages of 18 and 65 who had been experiencing neck pain at rest with a score of 3 or more on the VAS for at least 3 months.

You may qualify if:

  • It is worth noting that all individuals participating in the study provided written informed consent. The study involved individuals between the ages of 18 and 65 who had been experiencing neck pain at rest with a score of 3 or more on the VAS for at least 3 months.

You may not qualify if:

  • It was ensured that these individuals did not have any neurological deficits or pathological findings, such as fracture, dislocation, tumor, or infection, in radiological examinations.
  • Neurological or psychiatric diseases, a history of head trauma resulting in loss of consciousness, epilepsy, a history of neurosurgical intervention, intracranial hypertension, cancer, diabetes, dementia, brain dysfunction, psychological problems such as depression and anxiety diagnosed by a specialist physician and receiving treatment for these diseases
  • Individuals who were illiterate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sarıkaya Physical Therapy and Rehabilitation

Yozgat, Turkey (Türkiye)

Location

Related Publications (4)

  • Beltran-Alacreu H, Lopez-de-Uralde-Villanueva I, Calvo-Lobo C, Fernandez-Carnero J, La Touche R. Clinical features of patients with chronic non-specific neck pain per disability level: A novel observational study. Rev Assoc Med Bras (1992). 2018 Aug;64(8):700-709. doi: 10.1590/1806-9282.64.08.700.

    PMID: 30673040BACKGROUND
  • Bjorklund M, Hamberg J, Heiden M, Barnekow-Bergkvist M. The ProFitMap-neck--reliability and validity of a questionnaire for measuring symptoms and functional limitations in neck pain. Disabil Rehabil. 2012;34(13):1096-107. doi: 10.3109/09638288.2011.635747. Epub 2011 Dec 12.

    PMID: 22149067BACKGROUND
  • Hyland-Monks R, Cronin L, McNaughton L, Marchant D. The role of executive function in the self-regulation of endurance performance: A critical review. Prog Brain Res. 2018;240:353-370. doi: 10.1016/bs.pbr.2018.09.011. Epub 2018 Oct 17.

  • Zhao H, Alam A, Chen Q, A Eusman M, Pal A, Eguchi S, Wu L, Ma D. The role of microglia in the pathobiology of neuropathic pain development: what do we know? Br J Anaesth. 2017 Apr 1;118(4):504-516. doi: 10.1093/bja/aex006.

MeSH Terms

Conditions

Neck PainNeurobehavioral Manifestations

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNervous System Diseases

Study Officials

  • Tuğba Dere, MSc

    Yozgat Bozok University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

July 3, 2024

First Posted

July 16, 2024

Study Start

January 1, 2024

Primary Completion

May 20, 2024

Study Completion

June 20, 2024

Last Updated

July 16, 2024

Record last verified: 2024-07

Locations