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AAI in Elderly Patient With Chronic Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Animal-assisted therapy
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Pain focused on measuring Animal-assisted therapy, Chronic Pain, Elderly, Primary Health Care

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental Group

    Control Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change from baseline Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index at 13 weeks
    pain (0-20), stiffness (0-8), functional capacity (0-68)

    Secondary Outcome Measures

    Change from baseline Lattinen test at 13 weeks
    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
    Change from baseline EuroQoL Health Questionnaire at 13 weeks
    Is a generic self-administered instrument for measuring quality of life related to health
    Change from baseline Health Assessment Questionnaire at 13 weeks
    Is a self-administered questionnaire that assesses one's ability to perform day-to-day activities, as well as functional capacity
    Change from baseline Visual Analog Scale at session 1
    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.
    Change from baseline Visual Analog Scale at session 2
    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.
    Change from baseline Visual Analog Scale at session 3
    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.
    Change from baseline Visual Analog Scale at session 4
    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.
    Change from baseline Visual Analog Scale at session 5
    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.
    Change from baseline Visual Analog Scale at session 6
    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.
    Change from baseline Visual Analog Scale at session 7
    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.
    Change from baseline Visual Analog Scale at session 8
    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.
    Change from baseline Visual Analog Scale at session 9
    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.
    Change from baseline Visual Analog Scale at session 10
    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.
    Change from baseline Visual Analog Scale at session 11
    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.
    Change from baseline Visual Analog Scale at session 12
    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.

    Full Information

    First Posted
    July 5, 2019
    Last Updated
    September 3, 2019
    Sponsor
    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04079985
    Brief Title
    AAI in Elderly Patient With Chronic Pain
    Official Title
    Animal-assisted Intervention in Geriatric Patients With Chronic Joint Pain and Polypharmacy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2013 (Actual)
    Primary Completion Date
    June 1, 2014 (Actual)
    Study Completion Date
    October 1, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain
    Keywords
    Animal-assisted therapy, Chronic Pain, Elderly, Primary Health Care

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Single-centre, two-arm randomized, controlled, open-label clinical trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    69 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Animal-assisted therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from baseline Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index at 13 weeks
    Description
    pain (0-20), stiffness (0-8), functional capacity (0-68)
    Time Frame
    This questionnaire was administered at baseline and at week 13.
    Secondary Outcome Measure Information:
    Title
    Change from baseline Lattinen test at 13 weeks
    Description
    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
    Time Frame
    This questionnaire was administered at baseline and at week 13.
    Title
    Change from baseline EuroQoL Health Questionnaire at 13 weeks
    Description
    Is a generic self-administered instrument for measuring quality of life related to health
    Time Frame
    This questionnaire was administered at baseline and at week 13.
    Title
    Change from baseline Health Assessment Questionnaire at 13 weeks
    Description
    Is a self-administered questionnaire that assesses one's ability to perform day-to-day activities, as well as functional capacity
    Time Frame
    This questionnaire was administered at baseline and at week 13.
    Title
    Change from baseline Visual Analog Scale at session 1
    Description
    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.
    Time Frame
    This questionnaire was administered at the baseline of session 1 and through session 1 completion, an average of 1 hour
    Title
    Change from baseline Visual Analog Scale at session 2
    Description
    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.
    Time Frame
    This questionnaire was administered at the baseline of session 2 and through session 2 completion, an average of 1 hour
    Title
    Change from baseline Visual Analog Scale at session 3
    Description
    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.
    Time Frame
    This questionnaire was administered at the baseline of session 3 and through session 3 completion, an average of 1 hour
    Title
    Change from baseline Visual Analog Scale at session 4
    Description
    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.
    Time Frame
    This questionnaire was administered at the baseline of session 4 and through session 4 completion, an average of 1 hour
    Title
    Change from baseline Visual Analog Scale at session 5
    Description
    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.
    Time Frame
    This questionnaire was administered at the baseline of session 5 and through session 5 completion, an average of 1 hour
    Title
    Change from baseline Visual Analog Scale at session 6
    Description
    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.
    Time Frame
    This questionnaire was administered at the baseline of session 6 and through session 6 completion, an average of 1 hour
    Title
    Change from baseline Visual Analog Scale at session 7
    Description
    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.
    Time Frame
    This questionnaire was administered at the baseline of session 7 and through session 7 completion, an average of 1 hour
    Title
    Change from baseline Visual Analog Scale at session 8
    Description
    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.
    Time Frame
    This questionnaire was administered at the baseline of session 8 and through session 8 completion, an average of 1 hour
    Title
    Change from baseline Visual Analog Scale at session 9
    Description
    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.
    Time Frame
    This questionnaire was administered at the baseline of session 9 and through session 9 completion, an average of 1 hour
    Title
    Change from baseline Visual Analog Scale at session 10
    Description
    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.
    Time Frame
    This questionnaire was administered at the baseline of session 10 and through session 10 completion, an average of 1 hour
    Title
    Change from baseline Visual Analog Scale at session 11
    Description
    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.
    Time Frame
    This questionnaire was administered at the baseline of session 11 and through session 11 completion, an average of 1 hour
    Title
    Change from baseline Visual Analog Scale at session 12
    Description
    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.
    Time Frame
    This questionnaire was administered at the baseline of session 12 and through session 12 completion, an average of 1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marta Ortega Bravo, PhD
    Organizational Affiliation
    IDIAPJGol
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.tesisenred.net/handle/10803/385217
    Description
    Doctoral thesis

    Learn more about this trial

    AAI in Elderly Patient With Chronic Pain

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