AAI in Elderly Patient With Chronic Pain

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: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Animal-assisted therapy

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change from baseline Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index at 13 weeks	pain (0-20), stiffness (0-8), functional capacity (0-68)	This questionnaire was administered at baseline and at week 13.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	This questionnaire was administered at baseline and at week 13.
Change from baseline EuroQoL Health Questionnaire at 13 weeks	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	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	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Investigators: Study Director: Marta Ortega Bravo, PhD, IDIAPJGol

Publications and helpful links

Helpful Links

• Doctoral thesis

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Elderly; Chronic Pain; Primary Health Care; Animal-assisted therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID 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