Clinical trial NCT04079985: AAI in Elderly Patient With Chronic Pain
Official title: Animal-assisted Intervention in Geriatric Patients With Chronic Joint Pain and Polypharmacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Animal-assisted therapy
Chronic Pain
Elderly
Primary Health Care
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 69
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre, two-arm randomized, controlled, open-label clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Change from baseline Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index at 13 weeks
timeFrame: This questionnaire was administered at baseline and at week 13.
Secondary outcomes:
measure: Change from baseline Lattinen test at 13 weeks
timeFrame: This questionnaire was administered at baseline and at week 13.
measure: Change from baseline EuroQoL Health Questionnaire at 13 weeks
timeFrame: This questionnaire was administered at baseline and at week 13.
measure: Change from baseline Health Assessment Questionnaire at 13 weeks
timeFrame: This questionnaire was administered at baseline and at week 13.
measure: Change from baseline Visual Analog Scale at session 1
timeFrame: This questionnaire was administered at the baseline of session 1 and through session 1 completion, an average of 1 hour
measure: Change from baseline Visual Analog Scale at session 2
timeFrame: This questionnaire was administered at the baseline of session 2 and through session 2 completion, an average of 1 hour
measure: Change from baseline Visual Analog Scale at session 3
timeFrame: This questionnaire was administered at the baseline of session 3 and through session 3 completion, an average of 1 hour
measure: Change from baseline Visual Analog Scale at session 4
timeFrame: This questionnaire was administered at the baseline of session 4 and through session 4 completion, an average of 1 hour
measure: Change from baseline Visual Analog Scale at session 5
timeFrame: This questionnaire was administered at the baseline of session 5 and through session 5 completion, an average of 1 hour
measure: Change from baseline Visual Analog Scale at session 6
timeFrame: This questionnaire was administered at the baseline of session 6 and through session 6 completion, an average of 1 hour
measure: Change from baseline Visual Analog Scale at session 7
timeFrame: This questionnaire was administered at the baseline of session 7 and through session 7 completion, an average of 1 hour
measure: Change from baseline Visual Analog Scale at session 8
timeFrame: This questionnaire was administered at the baseline of session 8 and through session 8 completion, an average of 1 hour
measure: Change from baseline Visual Analog Scale at session 9
timeFrame: This questionnaire was administered at the baseline of session 9 and through session 9 completion, an average of 1 hour
measure: Change from baseline Visual Analog Scale at session 10
timeFrame: This questionnaire was administered at the baseline of session 10 and through session 10 completion, an average of 1 hour
measure: Change from baseline Visual Analog Scale at session 11
timeFrame: This questionnaire was administered at the baseline of session 11 and through session 11 completion, an average of 1 hour
measure: Change from baseline Visual Analog Scale at session 12
timeFrame: This questionnaire was administered at the baseline of session 12 and through session 12 completion, an average of 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: IDIAPJgol
name: Marta Ortega Bravo, PhD
role: STUDY_DIRECTOR
References: