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OpenTrials
Completed

NCT Number: NCT04079985

AAI in Elderly Patient With Chronic Pain

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Animal-assisted therapy

Other

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.

Primary outcomes

  1. Change from baseline Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index at 13 weeks

    Time frame: This questionnaire was administered at baseline and at week 13.

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

Secondary outcomes

  1. Change from baseline Lattinen test at 13 weeks

    Time frame: 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

  2. Change from baseline EuroQoL Health Questionnaire at 13 weeks

    Time frame: This questionnaire was administered at baseline and at week 13.

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

  3. Change from baseline Health Assessment Questionnaire at 13 weeks

    Time frame: 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

  4. Change from baseline Visual Analog Scale at session 1

    Time frame: 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.

  5. Change from baseline Visual Analog Scale at session 2

    Time frame: 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.

  6. Change from baseline Visual Analog Scale at session 3

    Time frame: 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.

  7. Change from baseline Visual Analog Scale at session 4

    Time frame: 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.

  8. Change from baseline Visual Analog Scale at session 5

    Time frame: 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.

  9. Change from baseline Visual Analog Scale at session 6

    Time frame: 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.

  10. Change from baseline Visual Analog Scale at session 7

    Time frame: 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.

  11. Change from baseline Visual Analog Scale at session 8

    Time frame: 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.

  12. Change from baseline Visual Analog Scale at session 9

    Time frame: 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.

  13. Change from baseline Visual Analog Scale at session 10

    Time frame: 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.

  14. Change from baseline Visual Analog Scale at session 11

    Time frame: 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.

  15. Change from baseline Visual Analog Scale at session 12

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 6, 2019
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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