NCT06434688

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

May 27, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

May 30, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

May 9, 2024

Last Update Submit

May 23, 2024

Conditions

Keywords

mental fatigueMindfulnessInteroceptionProprioception

Outcome Measures

Primary Outcomes (11)

  • 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

  • General Body Awareness

    General body awareness of individuals will be assessed with the Body Awareness Questionnaire (BAQ).

    2024 may- 2024 July

  • 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

  • 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

  • weight transfer awareness

    Two scales were used to assess weight transfer awareness. Results will be recorded in kg.

    2024 may- 2024 July

  • neck awareness

    Individuals' neck awareness will be assessed with the Fremantle Neck Awareness Questionnaire (FreBFA).

    2024 may- 2024 July

  • mindfulness

    Short Form of the Five Facet Mindfulness Questionnaire (FFMQ - Short Form) will be used to assess people's mindfulness

    2024 may- 2024 July

  • 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

  • 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

  • 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

  • extroception

    The sense of extroception will be evaluated with the right-left hand confusion test.

    2024 may- 2024 July

Secondary Outcomes (6)

  • Pain Assessment

    2024 may- 2024 July

  • Pain self efficacy

    2024 may- 2024 July

  • Anxiety and Depression

    2024 may- 2024 July

  • Range of motion

    2024 may- 2024 July

  • Posture Assesment

    2024 may- 2024 July

  • +1 more secondary outcomes

Study Arms (2)

Individuals experiencing neck pain

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 Status Examination. * Being able to read and write. * Being willing 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 neurologic diseases. * Inflammatory diseases * 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 disorders such as bipolar disorder and panic attacks. * Vision problems that do not improve despite vision aids. * Pregnancy

Other: Mental Fatigue:Other: Body Awareness:Other: Neck Disability LevelOther: Quality Of LifeOther: Pain Assessment:Other: Physical Condition:Other: Anxiety and Depression:

Healthy individuals without neck pain

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

Other: Mental Fatigue:Other: Body Awareness:Other: Quality Of LifeOther: Physical Condition:Other: Anxiety and Depression:

Interventions

The Mental Fatigue Scale (MFS) will be used to assess mental fatigue.

Healthy individuals without neck painIndividuals experiencing neck pain

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.

Healthy individuals without neck painIndividuals experiencing neck pain

Neck disability index will be used to assess this parameter.

Individuals experiencing neck pain

SF-12 will be used to assess quality of life.

Healthy individuals without neck painIndividuals experiencing neck pain

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.

Individuals experiencing neck pain

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.

Healthy individuals without neck painIndividuals experiencing neck pain

Beck Depression and Beck Anxiety scales will be used to assess depression and anxiety.

Healthy individuals without neck painIndividuals experiencing neck pain

Eligibility Criteria

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

individuals with neck pain and healthy individuals without neck pain

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (TĂ¼rkiye)

Location

Related 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.

    PMID: 29304254BACKGROUND
  • 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.

    PMID: 36897182BACKGROUND

Related Links

MeSH Terms

Conditions

Neck PainMental Fatigue

Interventions

Quality of LifePatient Health Questionnaire

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFatigueBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesPsychological TestsBehavioral Disciplines and ActivitiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 30, 2024

Study Start

May 27, 2024

Primary Completion

July 29, 2024

Study Completion

September 30, 2024

Last Updated

May 30, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations