Clinical trial NCT06434688: Body Awareness and Mental Fatigue in Neck Pain
Official title: Examining Mental Fatigue, Body Awareness, and Mindfulness in People With Chronic Neck Pain
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neck Pain
Mental Fatigue
Mindfulness
Awareness
Keywords: mental fatigue
Mindfulness
Interoception
Proprioception
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: individuals with neck pain and healthy individuals without neck pain

Brief summary: The primary aim of the study was to examine the difference between mental fatigue, in-body, out-of-body and mindfulness parameters in people with chronic neck pain compared to a healthy control group, and to analyze the relationships between mental fatigue and neck disability level and awareness levels, and between awareness levels and neck disability level and quality of life.

The secondary aim was to examine the relationships between pain intensity, frequency, duration, pain self-efficacy, physical condition, anxiety and depression, mental fatigue and awareness levels in people with chronic neck pain.

Detailed description: Neck pain is a prevalent musculoskeletal issue that can cause significant disability. Individuals with neck pain may experience changes in muscle structure and behavior, as well as sensory-perceptual-motor issues such as decreased proprioception and related neuromuscular changes. Additionally, neck pain can lead to psychological problems such as anxiety and depression.Although some awareness parameters have been evaluated in studies on neck pain in the literature and it has been shown that chronic pain is associated with impaired body awareness and that this impairment contributes to and/or maintains chronic pain, no study has been found to examine all awareness parameters in detail. Another cause that compromises the accuracy of information contributing to body awareness is mental fatigue. Mental fatigue can negatively affect a person's level of perception. In one study, it was stated that mental fatigue was a determinant of neck disability, but studies on this subject were found to be very insufficient. Therefore, the aim of this study was to examine the sub-parameters of awareness and mental fatigue in people with chronic neck pain, to compare them with healthy people and to examine the relationship between the parameters evaluated.

Eligibility criteria: Study Group Inclusion Criteria:

* Having chronic neck pain for at least 3 months.
* Being between 18 and 65 years of age.
* Scoring 5 and above on the Neck Disability Questionnaire.
* Scoring 24 and above on the Mini Mental State Examination.
* To be able to read and write.
* Being volunteer to participate in the study.

Study Group Exclusion Criteria:

* Participation in any physical therapy program in the last 3 months.
* Having the following problems:
* Radiculopathy, myleopathy (motor and sensory loss) and other neurological diseases.
* Inflammatory diseases (rheumatoid arthritis, etc.).
* History of malignancy.
* Congenital spinal cord anomaly and congenital spinal deformities.
* Spinal pathologies, traumatic medulla spinalis injury and other medulla spinalis pathologies.
* Vestibular disorders.
* Diagnosed psychiatric illnesses such as bipolar disorder, psychotic illnesses and panic attacks.
* Vision problems that do not fully recover despite vision aids (glasses, etc.).
* Pregnancy status

Control Group Inclusion Criteria:

* Age between 18 and 65 years.
* Scoring 24 and above on the Mini Mental State Examination.
* To be able to read and write.
* Volunteering to participate in the study.

Control Group Exclusion Criteria:

* Having chronic pain in the spine, especially in the neck.
* Exclusion criteria for the study group

Primary outcomes:
measure: Mental Fatigue
timeFrame: 2024 may- 2024 July
measure: General Body Awareness
timeFrame: 2024 may- 2024 July
measure: Neck Disability
timeFrame: 2024 may- 2024 July
measure: General health questionnaire
timeFrame: 2024 may - 2024 July
measure: weight transfer awareness
timeFrame: 2024 may- 2024 July
measure: neck awareness
timeFrame: 2024 may- 2024 July
measure: mindfulness
timeFrame: 2024 may- 2024 July
measure: interoception
timeFrame: 2024 may- 2024 July
measure: proprioception
timeFrame: 2024 may- 2024 July
measure: verticality
timeFrame: 2024 may- 2024 July
measure: extroception
timeFrame: 2024 may- 2024 July
Secondary outcomes:
measure: Pain Assessment
timeFrame: 2024 may- 2024 July
measure: Pain self efficacy
timeFrame: 2024 may- 2024 July
measure: Anxiety and Depression
timeFrame: 2024 may- 2024 July
measure: Range of motion
timeFrame: 2024 may- 2024 July
measure: Posture Assesment
timeFrame: 2024 may- 2024 July
measure: Weight transfer
timeFrame: 2024 may- 2024 July
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhiye
Study officials:
References:
citation: Amiri Arimi S, Ghamkhar L, Kahlaee AH. The Relevance of Proprioception to Chronic Neck Pain: A Correlational Analysis of Flexor Muscle Size and Endurance, Clinical Neck Pain Characteristics, and Proprioception. Pain Med. 2018 Oct 1;19(10):2077-2088. doi: 10.1093/pm/pnx331.
citation: Dere T, Alemdaroglu-Gurbuz I. Muscular endurance and its association with neck pain, disability, neck awareness, and kinesiophobia in patients with chronic neck pain. Somatosens Mot Res. 2024 Sep;41(3):134-141. doi: 10.1080/08990220.2023.2186390. Epub 2023 Mar 10.