Clinical trial NCT06855797: Characterization of Chronic Pain in Elderly Population with Emphasis on Differences Between Gender
Official title: Characterization of Chronic Pain in Elderly Population with Emphasis on Differences Between Gender
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly
Chronic Pain
Gender
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 474
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity to pressure pain 5 minutes post recruitment
timeFrame: applied minutes 5 after recruitment of the subject.
measure: Sensitivity to pressure pain 10 minutes post recruitment
timeFrame: applied minutes 10 after recruitment of the subject.
measure: Sensitivity to pressure pain 15 minutes post recruitment
timeFrame: applied minutes 15 after recruitment of the subject.
Secondary outcomes:
measure: Mini Mental State Examination
timeFrame: applied in beginning of the interview
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade de Sao Paulo
state: SP
Study officials:
References:
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