Body Awareness and Mental Fatigue in Neck Pain

Neck Pain Clinical Trial

Official title:

Examining Mental Fatigue, Body Awareness, and Mindfulness in People With Chronic Neck Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434688
• Other study ID #: 10557444
• Status: Not yet recruiting
• Start date: May 27, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: September 30, 2024
• Est. primary completion date: July 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Awareness
• Fatigue
• Mental Fatigue
• Mindfulness
• Neck Pain

Intervention

Other:
• Mental Fatigue:
The Mental Fatigue Scale (MFS) will be used to assess mental fatigue.
• Body Awareness:
Individuals' general body awareness will be assessed with the Body Awareness Questionnaire (BAQ). Neck awareness of individuals will be assessed with the Fremantle Neck Awareness Questionnaire (FreBFA). Short Form of the Five Facet Mindfulness Questionnaire (FFMQ - Short Form) will be used to assess people's mindfulness. - In-body awareness: For the sense of interoception, the Multidimensional Assessment of Interoceptive Awareness Scale, which assesses interoceptive body awareness, will be used. To evaluate proprioception, a Cervical Range of Motion (CROM) device is used. The bucket test will be used to assess subjective visual verticality, which is one of the sub-dimensions of verticality perception. Two scales will be used to assess people's awareness of weight transfer symmetry. - Out of Body Awareness: "Right-Left Confusion Hand Test" will be used to evaluate the mental rotation skill within the scope of the sense of extroception.
• Neck Disability Level
Neck disability index will be used to assess this parameter.
• Quality Of Life
SF-12 will be used to assess quality of life.
• Pain Assessment:
Pain intensity will be assessed by Visual Analog Scale (VAS). In addition, pain duration and pain frequency will be questioned. The Pain Self-Efficacy Questionnaire will be used to assess the confidence of people with chronic pain to perform certain tasks and behaviors despite their pain.
• Physical Condition:
Normal range of motion of the cervical region will be evaluated with the "Cervical Range of Motion" device. New York Posture Rating Scale will be used to evaluate posture. Symmetry of weight transfer to both lower extremities of the individuals in standing upright position will be evaluated.
• Anxiety and Depression:
Beck Depression and Beck Anxiety scales will be used to assess depression and anxiety.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Sihhiye

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. 2023 Mar 10:1-8. doi: 10.1080/08990220.2023.2186390. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental Fatigue	The Mental Fatigue Scale (MFS) will be used to assess mental fatigue. It includes questions about general fatigue, lack of initiative, mental fatigue, concentration difficulties, memory problems, slowness of thinking, sensitivity to stress, increased tendency to be emotional, irritability, sensitivity to light and noise, decreased or increased sleep. It has a 7-point Likert-type scale and is scored from 0 to 3. A rating of 0 indicates normal functioning, 1 indicates mild problem, 2 indicates significant problem and 3 indicates maximum problem. According to the total score, 0-10= no mental fatigue problem, 10.5-14.5= mild mental fatigue, 15-20= quite serious mental fatigue, = 20.5= serious mental fatigue.	2024 may- 2024 July
Primary	General Body Awareness	General body awareness of individuals will be assessed with the Body Awareness Questionnaire (BAQ).	2024 may- 2024 July
Primary	Neck Disability	Neck disability index will be used to assess this parameter. The questionnaire contains 10 questions related to different activities. Each question is scored between 0 and 5. The level of disability is determined according to the total score obtained from the questionnaire. 0-4 = no disability, 5-14 = mild disability, 15-24 = moderate disability, 25- 34 = severe disability, 35 and above = total disability.	2024 may- 2024 July
Primary	General health questionnaire	The SF-12, which is more practical and shorter than the SF-36 but contains the same sub-dimensions as the SF-36, will be used to assess quality of life. SF-12 consists of 8 sub-dimensions and 12 items including physical functioning (2 items), physical role, body pain, general health, energy, social functioning, emotional role and mental health. The questionnaire scoring is calculated under the headings of physical and mental health, which are the two main components of general health.	2024 may - 2024 July
Primary	weight transfer awareness	Two scales were used to assess weight transfer awareness. Results will be recorded in kg.	2024 may- 2024 July
Primary	neck awareness	Individuals' neck awareness will be assessed with the Fremantle Neck Awareness Questionnaire (FreBFA).	2024 may- 2024 July
Primary	mindfulness	Short Form of the Five Facet Mindfulness Questionnaire (FFMQ - Short Form) will be used to assess people's mindfulness	2024 may- 2024 July
Primary	interoception	For the sense of interoception, the Multidimensional Assessment of Interoceptive Awareness Scale, which assesses interoceptive body awareness, will be used.	2024 may- 2024 July
Primary	proprioception	The Cervical Range of Motion (CROM) device is used to assess proprioception. The device assesses proprioception in 6 different directions of the neck.	2024 may- 2024 July
Primary	verticality	The bucket test will be used to assess subjective visual verticality, which is one of the sub-dimensions of verticality perception.	2024 may- 2024 July
Primary	extroception	The sense of extroception will be evaluated with the right-left hand confusion test.	2024 may- 2024 July
Secondary	Pain Assessment	Pain intensity will be assessed by Visual Analog Scale (VAS).0: I have no pain 10: I have unbearable pain In addition, pain duration and pain frequency will be questioned.	2024 may- 2024 July
Secondary	Pain self efficacy	The Pain Self-Efficacy Questionnaire will be used to assess the confidence of people with chronic pain to perform certain tasks and behaviors despite their pain. Each item is rated on a 7-point Likert-type scale (0=not at all confident, 6=fully confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy for functioning despite pain.	2024 may- 2024 July
Secondary	Anxiety and Depression	Beck Depression and Beck Anxiety scales will be used to assess depression and anxiety. Both questionnaires have 21 questions and are scored between 0-3. According to the total scores, 0-9 points in the Beck Depression Scale indicates normal level, 10-16 points indicates mild depression, 17-29 points indicates moderate depression and 30-63 points indicates severe depression. On the Beck Anxiety Scale, 0-17 points are classified as low anxiety, 18-24 points as moderate anxiety, and 25 and above points as high anxiety.	2024 may- 2024 July
Secondary	Range of motion	Normal range of motion of the cervical region will be evaluated with the "Cervical Range of Motion" device. Active ranges of motion in flexion-extension, lateral flexion and rotation directions will be recorded with the subjec	2024 may- 2024 July
Secondary	Posture Assesment	New York Posture Rating Scale will be used to evaluate posture. Posture changes that may occur in 13 different parts of the body including head, neck, shoulders, shoulders, back, waist, hip and ankle are observed. According to the results of the observation, five (5) points are given if the person has proper posture, three (3) points if the posture is moderately impaired, and one (1) point if there is a serious impairment. A high score means that the posture is good.	2024 may- 2024 July
Secondary	Weight transfer	Symmetry of weight transfer to both lower extremities of the individuals in a standing upright position will be evaluated. It will be recorded in kg.	2024 may- 2024 July

External Links

•   Muscular endurance and its association with neck pain, disability, neck awareness, and kinesiophobia in patients with chronic neck pain
•   The Relevance of Proprioception to Chronic Neck Pain: A Correlational Analysis of Flexor Muscle Size and Endurance, Clinical Neck Pain Characteristics, and Proprioception