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AAI in Elderly Patient With Chronic Pain

Not Applicable
Completed
Conditions
Chronic Pain
Interventions
Other: Animal-assisted therapy
Registration Number
NCT04079985
Lead Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
69
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental GroupAnimal-assisted therapyThe 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.
Control GroupAnimal-assisted therapyThe 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.
Primary Outcome Measures
NameTimeMethod
Change from baseline Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index at 13 weeksThis questionnaire was administered at baseline and at week 13.

pain (0-20), stiffness (0-8), functional capacity (0-68)

Secondary Outcome Measures
NameTimeMethod
Change from baseline Lattinen test at 13 weeksThis 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

Change from baseline EuroQoL Health Questionnaire at 13 weeksThis questionnaire was administered at baseline and at week 13.

Is a generic self-administered instrument for measuring quality of life related to health

Change from baseline Visual Analog Scale at session 1This 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.

Change from baseline Visual Analog Scale at session 2This 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.

Change from baseline Visual Analog Scale at session 7This 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.

Change from baseline Visual Analog Scale at session 5This 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.

Change from baseline Visual Analog Scale at session 6This 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.

Change from baseline Visual Analog Scale at session 11This 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.

Change from baseline Visual Analog Scale at session 12This 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.

Change from baseline Visual Analog Scale at session 4This 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.

Change from baseline Visual Analog Scale at session 9This 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.

Change from baseline Health Assessment Questionnaire at 13 weeksThis 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

Change from baseline Visual Analog Scale at session 3This 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.

Change from baseline Visual Analog Scale at session 8This 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.

Change from baseline Visual Analog Scale at session 10This 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.

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