NCT06855797

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

Completed Last updated 4 March 2025

What this trial tests

trial testing Observation in Elderly in 474 participants. Completed in 10 July 2020.

Timeline

5 July 2017

Primary endpoint
10 July 2019

10 July 2020

Quick facts

Lead sponsor	University of Sao Paulo General Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	474
Start date	5 July 2017
Primary completion	10 July 2019
Estimated completion	10 July 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Observation

Conditions studied

• Elderly — all drugs for Elderly →
• Chronic Pain — all drugs for Chronic Pain →
• Gender — all drugs for Gender →

Sponsor

University of Sao Paulo General Hospital

Who can join

60 and older, any sex, with Elderly or Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pain thresholds in elderly individuals: a cross-sectional observational study of the influence of gender and chronic non-cancer pain.
   Gouvêa ÁL, Anuardo PA, Solano JPC, Sousa ÂM, et al · · 2025 · PMID 40744361 · DOI 10.1016/j.bjane.2025.844665