The Relationship Between Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Geriatric Individuals
Primary Purpose
Geriatric Individuals, Pain, Discomfort
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The relationship between pain perception, temporomandibular joint disorder severity and spine health
Sponsored by
About this trial
This is an interventional other trial for Geriatric Individuals focused on measuring Geriatric individuals, Pain, Discomfort, Spine, Temporomandibular disorder
Eligibility Criteria
Inclusion Criteria: To be volunteer Exclusion Criteria: Having any neurological, psychiatric or cognitive disorder
Sites / Locations
- Tokat Gaziosmanpasa UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Geriatric individuals
Arm Description
The relationship among pain perception, temporomandibular joint disorder severity and spine health
Outcomes
Primary Outcome Measures
The Centrality of Pain Scale
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.
Discomfort Intolerance Scale
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.
Spine Functional Index
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.
Fonseca Anamnestic Index
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06053008
First Posted
September 13, 2023
Last Updated
September 21, 2023
Sponsor
Tokat Gaziosmanpasa University
1. Study Identification
Unique Protocol Identification Number
NCT06053008
Brief Title
The Relationship Between Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Geriatric Individuals
Official Title
The Relationship Between Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Geriatric Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is aimed to examine the relationship between pain perception, temporomandibular joint disorder severity and spine health in elderly individuals.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geriatric Individuals, Pain, Discomfort, Spine, Temporomandibular Disorder
Keywords
Geriatric individuals, Pain, Discomfort, Spine, Temporomandibular disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Geriatric individuals
Arm Type
Other
Arm Description
The relationship among pain perception, temporomandibular joint disorder severity and spine health
Intervention Type
Other
Intervention Name(s)
The relationship between pain perception, temporomandibular joint disorder severity and spine health
Intervention Description
The relationship between pain perception, temporomandibular joint disorder severity and spine health
Primary Outcome Measure Information:
Title
The Centrality of Pain Scale
Description
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.
Time Frame
up to 3 months
Title
Discomfort Intolerance Scale
Description
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.
Time Frame
up to 3 months
Title
Spine Functional Index
Description
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.
Time Frame
up to 3 months
Title
Fonseca Anamnestic Index
Description
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.
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be volunteer
Exclusion Criteria:
Having any neurological, psychiatric or cognitive disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Halime ARIKAN, PhD
Phone
+90 546 576 51 32
Email
halimearikan92@gmail.com
Facility Information:
Facility Name
Tokat Gaziosmanpasa University
City
Tokat
ZIP/Postal Code
60250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halime ARIKAN, PhD
Phone
+90 546 576 51 32
Email
halimearikan92@gmail.com
12. IPD Sharing Statement
Learn more about this trial
The Relationship Between Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Geriatric Individuals
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