Geriatric IndividualsNCT06053008
The Relationship Between Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Geriatric Individuals
A study testing The relationship between pain perception, temporomandibular joint disorder severity and spine health in people with Geriatric Individuals and Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to examine the relationship between pain perception, temporomandibular joint disorder severity and spine health in elderly individuals. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Geriatric Individuals, Pain, Discomfort
- What is being tested?
- The relationship between pain perception, temporomandibular joint disorder severity and spine health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 29 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- To be volunteer
Who cannot join
- Having any neurological, psychiatric or cognitive disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, Tokat Province, 60250
About this study
It is aimed to examine the relationship between pain perception, temporomandibular joint disorder severity and spine health in elderly individuals.
Read the 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.
- Conditions
- Geriatric Individuals, Pain, Discomfort, Spine, Temporomandibular Disorder
- Being tested
- The relationship between pain perception, temporomandibular joint disorder severity and spine health
- Keywords
- Geriatric individuals, Pain, Discomfort, Spine, Temporomandibular disorder
- Medical subject headings
- Pain, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The relationship between pain perception, temporomandibular joint disorder severity and spine healthOther
The relationship between pain perception, temporomandibular joint disorder severity and spine health
| Study group | Role | What they receive |
|---|---|---|
| Geriatric individuals | Other | The relationship among pain perception, temporomandibular joint disorder severity and spine health Receives: Other: The relationship between pain perception, temporomandibular joint disorder severity and spine health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 months
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.
Measured: up to 3 months
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.
Measured: up to 3 months
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.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Aug 2023
- Primary completion1 Oct 2023
- Study completion29 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime Arikan, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053008
- Sponsor's protocol ID
- 13.27
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Geriatric Individuals
- ClinicalTrials.gov ID
- NCT06053008
- Acronym / sponsor ID
- 13.27
- Conditions
- Geriatric Individuals, Pain, Discomfort, Spine, Temporomandibular Disorder
- Keywords
- Geriatric individuals, Pain, Discomfort, Spine, Temporomandibular disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 29 Dec 2024 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric individuals | Other | Other: The relationship between pain perception, temporomandibular joint disorder severity and spine healthThe relationship among pain perception, temporomandibular joint disorder severity and spine health |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- To be volunteer
Key exclusion criteria (1 listed)
- Having any neurological, psychiatric or cognitive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The relationship between pain perception, temporomandibular joint disorder severity and spine healthThe relationship between pain perception, temporomandibular joint disorder severity and spine health | Other | Geriatric individuals |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The relationship between pain perception, temporomandibular joint disorder severity and spine health in people with Geriatric Individuals and Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Centrality of Pain Scale (time frame: up to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.