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

NCT06855797 | Completed DMC

• 1 other identifier: 43535915.0.0000.0068
• Study Type: observational
• Target: 474
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly; Chronic Pain; Gender

Outcome Measures

Primary Outcomes (3)

• Sensitivity to pressure pain 5 minutes post recruitment

  Pain evaluation throught algometer 5 minutes post recruitment

  applied minutes 5 after recruitment of the subject.

• Sensitivity to pressure pain 10 minutes post recruitment

  Pain evaluation throught algometer 10 minutes post recruitment

  applied minutes 10 after recruitment of the subject.

• Sensitivity to pressure pain 15 minutes post recruitment

  Pain evaluation throught algometer 15 minutes post recruitment

  applied minutes 15 after recruitment of the subject.

Secondary Outcomes (1)

• Mini Mental State Examination

  applied in beginning of the interview

Study Arms (2)

Male

Male, patients

Other: Observation

Female

Female patients

Other: Observation

Interventions

Observation OTHER

questionnaire

Female; Male

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: Self representation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Cognitive difficulty in understanding and responding to research questions
• Do not accept participation in the study

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Universidade de Sao Paulo

São Paulo, São Paulo, 01239-011, Brazil

Location

Related Publications (5)

• Valkenburg HA. Epidemiologic considerations of the geriatric population. Gerontology. 1988;34 Suppl 1:2-10. doi: 10.1159/000212980.

  PMID: 3266492 BACKGROUND

• 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.

  PMID: 12583868 BACKGROUND

• 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.

  PMID: 9520232 BACKGROUND

• 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.

  PMID: 23794645 BACKGROUND

• 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.

  PMID: 15561396 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Coitus

Interventions

Observation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: March 4, 2025
• Study Start: July 5, 2017
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2020
• Last Updated: March 4, 2025

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)