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

Sponsor
Tokat Gaziosmanpasa University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06053008
Collaborator
(none)
64
1
1
3
21.4

Study Details

Study Description

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
  • Other: The relationship between pain perception, temporomandibular joint disorder severity and spine health
N/A

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

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Primary Outcome Measures

  1. The Centrality of Pain Scale [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 [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 [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 [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

Criteria

Ages Eligible for Study:
65 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • To be volunteer
Exclusion Criteria:
  • Having any neurological, psychiatric or cognitive disorder

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tokat Gaziosmanpasa University Tokat Turkey 60250

Sponsors and Collaborators

  • Tokat Gaziosmanpasa University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Halime Arikan, Assistant Professor, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier:
NCT06053008
Other Study ID Numbers:
  • 13.27
First Posted:
Sep 25, 2023
Last Update Posted:
Sep 25, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Halime Arikan, Assistant Professor, Tokat Gaziosmanpasa University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 25, 2023