AAI in Elderly Patient With Chronic Pain

September 3, 2019 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Animal-assisted Intervention in Geriatric Patients With Chronic Joint Pain and Polypharmacy

BACKGROUND: Nowadays, there is a progressive aging of population. Chronic osteoarticular pain is associated to a bigger consumption of medication and a deterioration of life quality in elderly people that could be improved by boosting education for health from Primary Health Care. JUSTIFICATION: The need to develop non pharmacological treatments in order to get better results in people's global care. PURPOSE: To evaluate the effectivity of group intervention, based on Animal Assisted Therapy, on elderly people suffering from chronic osteoarticular pain and poli-medication; regarding decrease of chronic pain, use of analgesics and improvement of life quality. MATERIAL AND METHOD: Randomized clinical trial, two arms, controlled and open-label. Twelve group sessions of kinesiotherapy with the intervention of a therapy dog in the experimental group (EG), carried out in the Primary Health Centre.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥65 years
  • diagnosis of chronic benign joint pain
  • polypharmacy (>5 drugs or active ingredients, of which 2 or more had been prescribed for pain)

Exclusion Criteria:

  • severe cognitive deterioration (GDS> 5)
  • allergy to or fear of animals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
The experimental Group underwent a therapeutic intervention based on sessions of kinesitherapy , which is defined as a set of "therapeutic procedures that use movement for the treatment and prevention of diseases of the locomotive apparatus". The experimental group also underwent AAT. We conducted a total of 12 weekly sessions of 60 minutes each with 10 participants.
Other: Animal-assisted therapy
The sessions were held in the primary care centre, and had specific objectives agreed in advance by the research team. The sessions had the following schedule: Session 1, lower extremities in sitting position; Session 2, upper extremities in sitting position; Session 3, cervical spine in sitting position; Session 4, dorsal spine in sitting position; Session 5, lumbar spine in sitting position; Session 6, Static Standing and Upper Extremities; Session 7, Static Standing; Sessions 8, 9, 10 and 11, Dynamic Standing; and Session 12, Safety Reinforcement.
Active Comparator: Control Group
The Control Group underwent a therapeutic intervention based on sessions of kinesitherapy , which is defined as a set of "therapeutic procedures that use movement for the treatment and prevention of diseases of the locomotive apparatus" without the presence of the therapy dog.
Other: Animal-assisted therapy
The sessions were held in the primary care centre, and had specific objectives agreed in advance by the research team. The sessions had the following schedule: Session 1, lower extremities in sitting position; Session 2, upper extremities in sitting position; Session 3, cervical spine in sitting position; Session 4, dorsal spine in sitting position; Session 5, lumbar spine in sitting position; Session 6, Static Standing and Upper Extremities; Session 7, Static Standing; Sessions 8, 9, 10 and 11, Dynamic Standing; and Session 12, Safety Reinforcement.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index at 13 weeks
Time Frame: This questionnaire was administered at baseline and at week 13.
pain (0-20), stiffness (0-8), functional capacity (0-68)
This questionnaire was administered at baseline and at week 13.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline Lattinen test at 13 weeks
Time Frame: This questionnaire was administered at baseline and at week 13.
Assesses pain and any incapacity caused by pain, as well as its frequency and intensity, the amount of painkillers taken, and whether sleep is disturbed
This questionnaire was administered at baseline and at week 13.
Change from baseline EuroQoL Health Questionnaire at 13 weeks
Time Frame: This questionnaire was administered at baseline and at week 13.
Is a generic self-administered instrument for measuring quality of life related to health
This questionnaire was administered at baseline and at week 13.
Change from baseline Health Assessment Questionnaire at 13 weeks
Time Frame: This questionnaire was administered at baseline and at week 13.
Is a self-administered questionnaire that assesses one's ability to perform day-to-day activities, as well as functional capacity
This questionnaire was administered at baseline and at week 13.
Change from baseline Visual Analog Scale at session 1
Time Frame: This questionnaire was administered at the baseline of session 1 and through session 1 completion, an average of 1 hour
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
This questionnaire was administered at the baseline of session 1 and through session 1 completion, an average of 1 hour
Change from baseline Visual Analog Scale at session 2
Time Frame: This questionnaire was administered at the baseline of session 2 and through session 2 completion, an average of 1 hour
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
This questionnaire was administered at the baseline of session 2 and through session 2 completion, an average of 1 hour
Change from baseline Visual Analog Scale at session 3
Time Frame: This questionnaire was administered at the baseline of session 3 and through session 3 completion, an average of 1 hour
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
This questionnaire was administered at the baseline of session 3 and through session 3 completion, an average of 1 hour
Change from baseline Visual Analog Scale at session 4
Time Frame: This questionnaire was administered at the baseline of session 4 and through session 4 completion, an average of 1 hour
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
This questionnaire was administered at the baseline of session 4 and through session 4 completion, an average of 1 hour
Change from baseline Visual Analog Scale at session 5
Time Frame: This questionnaire was administered at the baseline of session 5 and through session 5 completion, an average of 1 hour
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
This questionnaire was administered at the baseline of session 5 and through session 5 completion, an average of 1 hour
Change from baseline Visual Analog Scale at session 6
Time Frame: This questionnaire was administered at the baseline of session 6 and through session 6 completion, an average of 1 hour
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
This questionnaire was administered at the baseline of session 6 and through session 6 completion, an average of 1 hour
Change from baseline Visual Analog Scale at session 7
Time Frame: This questionnaire was administered at the baseline of session 7 and through session 7 completion, an average of 1 hour
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
This questionnaire was administered at the baseline of session 7 and through session 7 completion, an average of 1 hour
Change from baseline Visual Analog Scale at session 8
Time Frame: This questionnaire was administered at the baseline of session 8 and through session 8 completion, an average of 1 hour
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
This questionnaire was administered at the baseline of session 8 and through session 8 completion, an average of 1 hour
Change from baseline Visual Analog Scale at session 9
Time Frame: This questionnaire was administered at the baseline of session 9 and through session 9 completion, an average of 1 hour
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
This questionnaire was administered at the baseline of session 9 and through session 9 completion, an average of 1 hour
Change from baseline Visual Analog Scale at session 10
Time Frame: This questionnaire was administered at the baseline of session 10 and through session 10 completion, an average of 1 hour
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
This questionnaire was administered at the baseline of session 10 and through session 10 completion, an average of 1 hour
Change from baseline Visual Analog Scale at session 11
Time Frame: This questionnaire was administered at the baseline of session 11 and through session 11 completion, an average of 1 hour
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
This questionnaire was administered at the baseline of session 11 and through session 11 completion, an average of 1 hour
Change from baseline Visual Analog Scale at session 12
Time Frame: This questionnaire was administered at the baseline of session 12 and through session 12 completion, an average of 1 hour
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
This questionnaire was administered at the baseline of session 12 and through session 12 completion, an average of 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Marta Ortega Bravo, PhD, IDIAPJGol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IDIAPJordiGol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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