AAI in Elderly Patient With Chronic Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04079985
• Other study ID #: IDIAPJordiGol
• Status: Completed
• Phase: N/A
• Start date: October 1, 2013
• Est. completion date: October 1, 2014

Study information

• Verified date: July 2019
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 1, 2014
• Est. primary completion date: June 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Doctoral thesis