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The Relationship Between Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Geriatric Individuals

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ClinicalTrials.gov Identifier: NCT06053008
Recruitment Status : Recruiting
First Posted : September 25, 2023
Last Update Posted : September 25, 2023
Sponsor:
Information provided by (Responsible Party):
Halime Arikan, Tokat Gaziosmanpasa University

Study Description
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Brief Summary:
It is aimed to examine the relationship between pain perception, temporomandibular joint disorder severity and spine health in elderly individuals.

Condition or disease Intervention/treatment Phase
Geriatric Individuals Pain Discomfort Spine Temporomandibular Disorder Other: The relationship between pain perception, temporomandibular joint disorder severity and spine health Not Applicable

Detailed Description:

The research sample will consist of elderly individuals who reside in Tokat and Kırıkkale, are over 65 years old, have good cognitive status, and volunteer to participate in the study. According to the G*Power analysis, if the sample size is α= 0.05, β= 0.80, acceptable correlation coefficient r= 0.70, and negligible correlation coefficient r= 0.20, 16 individuals are sufficient to measure the relationship between two parameters. Since the relationship between four parameters will be evaluated, 64 individuals are required.

Data for the study will be collected face to face by researchers using The Centrality of Pain Scale, Discomfort Intolerance Scale, Spine Functional Index, and Fonseca Anamnestic Index, which can be filled in by individuals themselves.

Statistical Package for Social Sciences (SPSS), version 22.0 computer package program for Windows, will be used for statistical analysis. Statistical data will be expressed as mean ± standard deviation (X±SD), median, or percentage (%). One Sample Kolmogorov Smirnov test will be performed to show the parametric or nonparametric distribution of the data. When parametric test assumptions are met, the relationship between parameters is determined by Spearman correlation test; When parametric test assumptions are not met, the relationship between the parameters will be examined with the Pearson correlation test. Statistical significance value will be accepted as p<0.05.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Relationship Between Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Geriatric Individuals
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Geriatric individuals
The relationship among pain perception, temporomandibular joint disorder severity and spine health
 Other: The relationship between pain perception, temporomandibular joint disorder severity and spine health
The relationship between pain perception, temporomandibular joint disorder severity and spine health


Outcome Measures
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Primary Outcome Measures :
  1. The Centrality of Pain Scale [ Time Frame: up to 3 months ]
    The Centrality of Pain Scale will be used to assess pain perception. It is a 10-item survey in which each item is rated on a 5-point Likert type (1: strongly disagree, 2: disagree, 3: neither agree nor disagree, 4: agree, 5: strongly agree). Items 2, 4, and 9 are reverse scored. The total score is the sum of all item scores. Higher scores reflect more "centralized" pain. The maximum score is 50, and the minimum score is 10. Turkish version, validity, and reliability study was conducted.

  2. Discomfort Intolerance Scale [ Time Frame: up to 3 months ]
    Tolerance to physical discomfort and pain will be evaluated with the Discomfort Intolerance Scale. The scale consists of 7-point Likert type questions and the answer options vary between 0 (not at all suitable for me) and 6 (completely suitable for me). A Turkish version, validity and reliability study is available.

  3. Spine Functional Index [ Time Frame: up to 3 months ]
    The Spine Functional Index is a scale of 25 questions developed to examine the impact of spine-related symptoms on functionality. Each question is scored as 0, 0.5, 1. The total score is calculated as a percentage, and a score approaching 100% indicates normal spinal functions. Turkish version, validity, and reliability were tested.

  4. Fonseca Anamnestic Index [ Time Frame: up to 3 months ]
    The presence and severity of temporomandibular disorder in individuals will be evaluated with the Fonseca Anamnestic Index. The Fonseca Anamnestic Index consists of 10 questions. The participant is asked to answer each question as 'Yes' (10 points), 'No' (0 points), and 'Sometimes' (5 points). The questionnaire score is scored for all questions, and temporomandibular disorder severity is classified according to the total score: no temporomandibular disorder (0-15 points), mild temporomandibular disorder (20-40 points), moderate temporomandibular disorder (45-65 points), severe temporomandibular disorder (45-65 points). 70-100). The Turkish version, validity, and reliability were tested.


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To be volunteer

Exclusion Criteria:

  • Having any neurological, psychiatric or cognitive disorder
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06053008


Contacts
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Contact: Halime ARIKAN, PhD +90 546 576 51 32 halimearikan92@gmail.com

Locations
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Turkey
Tokat Gaziosmanpasa University Recruiting
Tokat, Turkey, 60250
Contact: Halime ARIKAN, PhD    +90 546 576 51 32    halimearikan92@gmail.com   
Sponsors and Collaborators
Tokat Gaziosmanpasa University
More Information
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Responsible Party: Halime Arikan, Assistant Professor, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT06053008    
Other Study ID Numbers: 13.27
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: September 25, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Halime Arikan, Tokat Gaziosmanpasa University:
Geriatric individuals
Pain
Discomfort
Spine
Temporomandibular disorder
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Joint Diseases
Craniomandibular Disorders
Mandibular Diseases
 Jaw Diseases
Musculoskeletal Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes