Chronic Pain
Conditions
Keywords
Animal-assisted therapy, Chronic Pain, Elderly, Primary Health Care
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.
Interventions
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.
Sponsors
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Single-centre, two-arm randomized, controlled, open-label clinical trial
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index at 13 weeks | This questionnaire was administered at baseline and at week 13. | pain (0-20), stiffness (0-8), functional capacity (0-68) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline EuroQoL Health Questionnaire at 13 weeks | This 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 Health Assessment Questionnaire at 13 weeks | This 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 1 | This 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 2 | This 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 3 | This 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 4 | This 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 5 | This 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 Lattinen test at 13 weeks | This 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 Visual Analog Scale at session 7 | This 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 8 | This 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 9 | This 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 Visual Analog Scale at session 10 | This 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. |
| Change from baseline Visual Analog Scale at session 11 | This 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 12 | This 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 6 | This 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. |
Outcome results
None listed