ElderlyNCT06855797
Characterization of Chronic Pain in Elderly Population With Emphasis on Differences Between Gender
An observational study of Elderly and Chronic Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly, Chronic Pain, Gender
- What is being tested?
- Observation
- How many people
- 474 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jul 2017to 10 Jul 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Cognitive difficulty in understanding and responding to research questions
- Do not accept participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Observation
- Medical subject headings
- Chronic Pain, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Male | Male, patients Receives: Other: Observation | |
| Female | Female patients Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity to pressure pain 5 minutes post recruitment
Pain evaluation throught algometer 5 minutes post recruitment
Measured: applied minutes 5 after recruitment of the subject.
Sensitivity to pressure pain 10 minutes post recruitment
Pain evaluation throught algometer 10 minutes post recruitment
Measured: applied minutes 10 after recruitment of the subject.
Sensitivity to pressure pain 15 minutes post recruitment
Pain evaluation throught algometer 15 minutes post recruitment
Measured: applied minutes 15 after recruitment of the subject.
Secondary outcomes (1)
Mini Mental State Examination
Mental state evaluation
Measured: applied in beginning of the interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start5 Jul 2017
- Primary completion10 Jul 2019
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 474 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855797
- Sponsor's protocol ID
- 43535915.0.0000.0068
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2017
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valkenburg HA. Epidemiologic considerations of the geriatric population. Gerontology. 1988;34 Suppl 1:2-10. doi: 10.1159/000212980.
PubMed 3266492Chesterton 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.
PubMed 12583868Riley 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.
PubMed 9520232Bartley 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.
PubMed 23794645Peat 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.
PubMed 15561396Gouvea AL, Anuardo PA, Solano JPC, Sousa AM, Ashmawi HA. Pain thresholds in elderly individuals: a cross-sectional observational study of the influence of gender and chronic non-cancer pain. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844665. doi: 10.1016/j.bjane.2025.844665. Epub 2025 Jul 29.
PubMed 40744361
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Chronic Pain in Elderly Population With Emphasis on Differences Between Gender
- ClinicalTrials.gov ID
- NCT06855797
- Acronym / sponsor ID
- 43535915.0.0000.0068
- Conditions
- Elderly, Chronic Pain, Gender
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male | – | Other: ObservationMale, patients |
| Female | – | Other: ObservationFemale patients |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitive difficulty in understanding and responding to research questions
- Do not accept participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observationquestionnaire | Other | Female, Male |
Primary outcome
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
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
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
1 secondary outcome
Mini Mental State Examination
Time frame: applied in beginning of the interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Results publication: PubMed 3266492Valkenburg HA. Epidemiologic considerations of the geriatric population. Gerontology. 1988;34 Suppl 1:2-10. doi: 10.1159/000212980.
- Results publication: PubMed 12583868Chesterton 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.
- Results publication: PubMed 9520232Riley 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.
- Results publication: PubMed 23794645Bartley 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.
- Results publication: PubMed 15561396Peat 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.
- Derived from this study: PubMed 40744361Gouvea AL, Anuardo PA, Solano JPC, Sousa AM, Ashmawi HA. Pain thresholds in elderly individuals: a cross-sectional observational study of the influence of gender and chronic non-cancer pain. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844665. doi: 10.1016/j.bjane.2025.844665. Epub 2025 Jul 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly and Chronic Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity to pressure pain 5 minutes post recruitment (time frame: applied minutes 5 after recruitment of the subject.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06855797, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.