- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06855797
Characterization of Chronic Pain in Elderly Population with Emphasis on Differences Between Gender
February 27, 2025 updated by: University of Sao Paulo General Hospital
Introduction: It is estimated that by 2025 there will be approximately 1.2 billion people above 60 years old.
Global projections indicate that by 2050 there will be about 2 billion elders, 80% of them living in developing countries.
Researches on the relationship between pain and aging are currently much valued within the health sciences, the ultimate goal being the provision of adequate pain control for the growing number of elders in society.
Objectives: To characterize chronic pain in the elderly population and evaluate pain threshold to mechanical stimulation, with emphasis on gender differences.
Methods: This study refers to a cross-sectional study to be conducted in convenience samples of a primary care unit (Geraldo Horacio de Paula Souza) that follows elders and the Department of Geriatrics of the university hospital of the School of Medicine of Universidade de São Paulo (Hospital das Clínicas).
At least 200 participants of each gender, aged 65 or above, will be selected to participate.
Chronic pain will be that lasting for six or more months (either continuous or recurrent, as recommended by the International Association For the Study of Pain).
Participants will be searched about their demographic and socioeconomic backgrounds, and asked to answer the following questionnaires: the Mini Mental State Examination, a structured questionnaire for activities of daily living, a structured questionnaire for instrumental activities of daily living, Beck Anxiety Inventory, Geriatric Depression Scale, the five dimensions European Quality of Life assessment (EQ5D) and Brief Pain Inventory.
Participants will also be evaluated regarding pain threshold to mechanical stimuli using algometer.
Descriptive statistics of the sample will be displayed as means, medians, standard deviations and proportions.
For testing for differences between males and females, a significance level of 5% will be used.
Keywords: elderly, chronic pain, gender.
Study Overview
Study Type
Observational
Enrollment (Actual)
474
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 01239-011
- Universidade de Sao Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Patient of the geriatrics clinic at the Central Institute (IC) of the Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) or the Geraldo Horácio de Paula Souza School of Public Health Center of the University of São Paulo
Description
Inclusion Criteria:
- Patient of the geriatrics clinic at the Central Institute (IC) of the Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) or the Geraldo Horácio de Paula Souza School of Public Health Center of the University of São Paulo
- Be over 65 years old
- Accept study participation
- Have read, understood, agreed and signed the TCLE
Exclusion Criteria:
- Cognitive difficulty in understanding and responding to research questions
- Do not accept participation in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Male
Male, patients
|
questionnaire
|
|
Female
Female patients
|
questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity to pressure pain 5 minutes post recruitment
Time Frame: applied minutes 5 after recruitment of the subject.
|
Pain evaluation throught algometer 5 minutes post recruitment
|
applied minutes 5 after recruitment of the subject.
|
|
Sensitivity to pressure pain 10 minutes post recruitment
Time Frame: applied minutes 10 after recruitment of the subject.
|
Pain evaluation throught algometer 10 minutes post recruitment
|
applied minutes 10 after recruitment of the subject.
|
|
Sensitivity to pressure pain 15 minutes post recruitment
Time Frame: applied minutes 15 after recruitment of the subject.
|
Pain evaluation throught algometer 15 minutes post recruitment
|
applied minutes 15 after recruitment of the subject.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini Mental State Examination
Time Frame: applied in beginning of the interview
|
Mental state evaluation
|
applied in beginning of the interview
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chesterton LS, Barlas P, Foster NE, Baxter DG, Wright CC. Gender differences in pressure pain threshold in healthy humans. Pain. 2003 Feb;101(3):259-266. doi: 10.1016/S0304-3959(02)00330-5.
- Bartley EJ, Fillingim RB. Sex differences in pain: a brief review of clinical and experimental findings. Br J Anaesth. 2013 Jul;111(1):52-8. doi: 10.1093/bja/aet127.
- Valkenburg HA. Epidemiologic considerations of the geriatric population. Gerontology. 1988;34 Suppl 1:2-10. doi: 10.1159/000212980.
- Riley JL 3rd, Robinson ME, Wise EA, Myers CD, Fillingim RB. Sex differences in the perception of noxious experimental stimuli: a meta-analysis. Pain. 1998 Feb;74(2-3):181-7. doi: 10.1016/s0304-3959(97)00199-1.
- Peat G, Thomas E, Handy J, Croft P. Social networks and pain interference with daily activities in middle and old age. Pain. 2004 Dec;112(3):397-405. doi: 10.1016/j.pain.2004.09.029.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2017
Primary Completion (Actual)
July 10, 2019
Study Completion (Actual)
July 10, 2020
Study Registration Dates
First Submitted
July 10, 2017
First Submitted That Met QC Criteria
February 27, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 27, 2025
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43535915.0.0000.0068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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