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OpenTrials
Completed

NCT Number: NCT06855797

Characterization of Chronic Pain in Elderly Population With Emphasis on Differences Between Gender

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidade de Sao Paulo

São Paulo, 01239-011, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

questionnaire

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Mini Mental State Examination

    Time frame: applied in beginning of the interview

    Mental state evaluation

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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